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Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. (REAL 1)

Primary Purpose

Growth Hormone Disorder, Adult Growth Hormone Deficiency

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

somapacitan

somatropin

placebo

About this trial

This is an interventional treatment trial for Growth Hormone Disorder

Eligibility Criteria

23 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent
Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)
If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
FOR ALL COUNTRIES EXCEPT JAPAN:

Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):

Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2, a peak GH less than 4 ng/mL (4 mcg/L)
Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):

a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)

Exclusion Criteria:

Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin
Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

NNC0195-0092 (somapacitan)

Daily hGH

Placebo

Arm Description

Switch to NNC0195-0092 (somapacitan) treatment in the extension period.

Outcomes

Primary Outcome Measures

Change in Truncal Fat Percentage (Week 34)

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).

Secondary Outcome Measures

Change in Truncal Fat Percentage (Week 87)

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Truncal Fat Mass (Week 34)

Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Truncal Fat Mass (Week 87)

Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Truncal Lean Body Mass (Week 34)

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Truncal Lean Body Mass (Week 87)

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Total Fat Mass (Week 34)

Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Total Fat Mass (Week 87)

Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Visceral Adipose Tissue (Week 34)

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Visceral Adipose Tissue (Week 87)

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Android Fat Mass (Week 34)

Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Android Fat Mass (Week 87)

Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Gynoid Fat Mass (Week 34)

Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Gynoid Fat Mass (Week 87)

Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Appendicular Skeletal Muscle Mass (Week 34)

Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Appendicular Skeletal Muscle Mass (Week 87)

Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Lean Body Mass (Week 34)

Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Lean Body Mass (Week 87)

Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Bone Mineral Content (Week 87)

Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Bone Mineral Density (Week 87)

Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in IGF-I SDS (Week 34)

Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.

Change in IGF-I SDS (Week 87)

Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.

Change in IGFBP 3 SDS (Week 34)

Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in IGFBP 3 SDS (Week 87)

Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in TRIM-AGHD (Total and Domain Scores) (Week 34)

Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

Change in TRIM-AGHD (Total and Domain Scores) (Week 87)

Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

Change in SF-36v2 (Summary and Domain Scores) (Week 34)

SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.

Change in SF-36v2 (Summary and Domain Scores) (Week 87)

TSQM-9 Scores (Domain Scores) (Week 34)

Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

TSQM-9 Scores (Domain Scores) (Week 87)

Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

Change in Total Cholesterol (Week 34)

Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Total Cholesterol (Week 87)

Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in HDL-cholesterol (Week 34)

Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in HDL-cholesterol (Week 87)

Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in LDL-cholesterol (Week 34)

Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in LDL-cholesterol (Week 87)

Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Triglycerides (Week 34)

Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Triglycerides (Week 87)

Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Hs-CRP (Week 34)

Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Hs-CRP (Week 87)

Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in IL-6 (Week 34)

Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in IL-6 (Week 87)

Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Body Weight (Week 34)

Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Body Weight (Week 87)

Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Waist Circumference (Week 34)

Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Waist Circumference (Week 87)

Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Number of Adverse Events (Weeks 0-35)

Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.

Number of Adverse Events (Weeks 0-88)

Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.

Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)

Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)

Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)

Incidence of technical complaints were recorded from baseline (week 0) until week 35.

Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)

Incidence of technical complaints were recorded from baseline (week 0) until week 88.

Change in Physical Examination During Exposure to Trial Product (Week 35)

Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation

Change in Physical Examination During Exposure to Trial Product (Week 88)

Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation

Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)

Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.

Change in ECG Evaluation During Exposure to Trial Product (Week 88)

Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.

Change in Diastolic Blood Pressure (Week 35)

Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

Change in Diastolic Blood Pressure (Week 88)

Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.

Change in Systolic Blood Pressure (Week 35)

Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

Change in Systolic Blood Pressure (Week 88)

Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).

Change in Pulse (Week 35)

Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).

Change in Pulse (Week 88)

Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).

Change in Haemoglobin (Week 34)

Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Haemoglobin (Week 87)

Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.

Change in Haematocrit (Week 34)

Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Haematocrit (Week 87)

Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.

Change in Erythrocytes (Week 34)

Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Erythrocytes (Week 87)

Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.

Change in Mean Corpuscular Volume (MCV) (Week 34)

Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Mean Corpuscular Volume (MCV) (Week 87)

Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.

Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)

Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)

Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.

Change in Thrombocytes (Week 34)

Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Thrombocytes (Week 87)

Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.

Change in Leucocytes (Week 34)

Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Leucocytes (Week 87)

Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.

Change in Alanine Aminotransferase (ALT) (Week 34)

Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Alanine Aminotransferase (ALT) (Week 87)

Change in ALT was measured from baseline (week -3) until the end of the week 87.

Change in Albumin (Week 34)

Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Albumin (Week 87)

Change in Albumin was measured from baseline (week -3) until the end of the week 87.

Change in Alkaline Phosphatase (ALP) (Week 34)

Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Alkaline Phosphatase (AP) (Week 87)

Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.

Change in Aspartate Aminotransferase (AST) (Week 34)

Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Aspartate Aminotransferase (AST) (Week 87)

Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Bilirubin (Week 34)

Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Bilirubin (Week 87)

Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Calcium (Week 34)

Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Calcium (Week 87)

Change in Calcium was measured from baseline (week -3) until the end of the week 87.

Change in Chloride (Week 34)

Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Chloride (Week 87)

Change in Chloride was measured from baseline (week -3) until the end of the week 87.

Change in Creatinine (Week 34)

Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Creatinine (Week 87)

Change in Creatinine was measured from baseline (week -3) until the end of the week 87.

Change in Creatine Kinase (Week 34)

Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Creatine Kinase (Week 87)

Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.

Change in Gamma-glutamyl Transferase (GGT) (Week 34)

Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Gamma-glutamyl Transferase (GGT) (Week 87)

Change in GGT was measured from baseline (week -3) until the end of the week 87.

Change in Phosphate (Inorganic) (Week 34)

Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Phosphate (Inorganic)(Week 87)

Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.

Change in Potassium (Week 34)

Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Potassium (Week 87)

Change in Potassium was measured from baseline (week -3) until the end of the week 87.

Change in Sodium (Week 34)

Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Sodium (Week 87)

Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Total Protein (Week 34)

Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Total Protein (Week 87)

Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).

Change in Urea (Week 34)

Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Urea (Week 87)

Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Uric Acid (Week 34)

Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Uric Acid (Week 87)

Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)

Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)

Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Fasting Plasma Glucose (Week 34)

Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Fasting Plasma Glucose (Week 87)

Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Fasting Insulin (Week 34)

Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Fasting Insulin (Week 87)

Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Steady State Beta Cell Function (%B) (Week 34)

Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Steady State Beta Cell Function (%B) (Week 87)

Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.

Change in Insulin Resistance (IR %) (Week 34)

Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Insulin Resistance (IR %) (Week 87)

Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)

Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)

Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Full Information

NCT ID

NCT02229851

First Posted

August 26, 2014

Last Updated

November 3, 2020

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02229851

Brief Title

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Acronym

REAL 1

Official Title

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 31, 2014 (Actual)

Primary Completion Date

April 21, 2017 (Actual)

Study Completion Date

May 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Growth Hormone Disorder, Adult Growth Hormone Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0195-0092 (somapacitan)

Arm Type

Experimental

Arm Title

Daily hGH

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Switch to NNC0195-0092 (somapacitan) treatment in the extension period.

Intervention Type

Drug

Intervention Name(s)

somapacitan

Other Intervention Name(s)

NNC0195-0092

Intervention Description

Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.

Intervention Type

Drug

Intervention Name(s)

somatropin

Intervention Description

Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.

Primary Outcome Measure Information:

Title

Change in Truncal Fat Percentage (Week 34)

Description

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Secondary Outcome Measure Information:

Title

Change in Truncal Fat Percentage (Week 87)

Description

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Truncal Fat Mass (Week 34)

Description

Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Truncal Fat Mass (Week 87)

Description

Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Truncal Lean Body Mass (Week 34)

Description

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Truncal Lean Body Mass (Week 87)

Description

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Total Fat Mass (Week 34)

Description

Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Total Fat Mass (Week 87)

Description

Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

Week -3, week 87

Title

Change in Visceral Adipose Tissue (Week 34)

Description

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Visceral Adipose Tissue (Week 87)

Description

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

Week -3, week 87

Title

Change in Android Fat Mass (Week 34)

Description

Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Android Fat Mass (Week 87)

Description

Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Gynoid Fat Mass (Week 34)

Description

Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Gynoid Fat Mass (Week 87)

Description

Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Appendicular Skeletal Muscle Mass (Week 34)

Description

Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Appendicular Skeletal Muscle Mass (Week 87)

Description

Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Lean Body Mass (Week 34)

Description

Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Lean Body Mass (Week 87)

Description

Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Bone Mineral Content (Week 87)

Description

Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Bone Mineral Density (Week 87)

Description

Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in IGF-I SDS (Week 34)

Description

Time Frame

Week -3, week 34

Title

Change in IGF-I SDS (Week 87)

Description

Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.

Time Frame

Week -3, week 87

Title

Change in IGFBP 3 SDS (Week 34)

Description

Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in IGFBP 3 SDS (Week 87)

Description

Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

Week -3, week 87

Title

Change in TRIM-AGHD (Total and Domain Scores) (Week 34)

Description

Time Frame

Week 0, week 34

Title

Change in TRIM-AGHD (Total and Domain Scores) (Week 87)

Description

Time Frame

week 0, week 87

Title

Change in SF-36v2 (Summary and Domain Scores) (Week 34)

Description

Time Frame

Week 0, week 34

Title

Change in SF-36v2 (Summary and Domain Scores) (Week 87)

Description

Time Frame

week 0, week 87

Title

TSQM-9 Scores (Domain Scores) (Week 34)

Description

Time Frame

Week 34

Title

TSQM-9 Scores (Domain Scores) (Week 87)

Description

Time Frame

Week 87

Title

Change in Total Cholesterol (Week 34)

Description

Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Total Cholesterol (Week 87)

Description

Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in HDL-cholesterol (Week 34)

Description

Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in HDL-cholesterol (Week 87)

Description

Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in LDL-cholesterol (Week 34)

Description

Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in LDL-cholesterol (Week 87)

Description

Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Triglycerides (Week 34)

Description

Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Triglycerides (Week 87)

Description

Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Hs-CRP (Week 34)

Description

Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Hs-CRP (Week 87)

Description

Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in IL-6 (Week 34)

Description

Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in IL-6 (Week 87)

Description

Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Body Weight (Week 34)

Description

Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Body Weight (Week 87)

Description

Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Waist Circumference (Week 34)

Description

Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Waist Circumference (Week 87)

Description

Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Number of Adverse Events (Weeks 0-35)

Description

Time Frame

Weeks 0-35

Title

Number of Adverse Events (Weeks 0-88)

Description

Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.

Time Frame

Weeks 0-88

Title

Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)

Description

Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

Time Frame

Weeks 0 to 35

Title

Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)

Description

Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

Time Frame

Weeks 0 to 88

Title

Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)

Description

Incidence of technical complaints were recorded from baseline (week 0) until week 35.

Time Frame

Weeks 0 to 35

Title

Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)

Description

Incidence of technical complaints were recorded from baseline (week 0) until week 88.

Time Frame

Weeks 0 to 88

Title

Change in Physical Examination During Exposure to Trial Product (Week 35)

Description

Time Frame

Week 0 and week 35

Title

Change in Physical Examination During Exposure to Trial Product (Week 88)

Description

Time Frame

Week 0 and week 88

Title

Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)

Description

Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.

Time Frame

Week -3 and week 35

Title

Change in ECG Evaluation During Exposure to Trial Product (Week 88)

Description

Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.

Time Frame

Week -3 and week 88

Title

Change in Diastolic Blood Pressure (Week 35)

Description

Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

Time Frame

Week -3, week 35

Title

Change in Diastolic Blood Pressure (Week 88)

Description

Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.

Time Frame

Week -3, week 88

Title

Change in Systolic Blood Pressure (Week 35)

Description

Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

Time Frame

Week -3, week 35

Title

Change in Systolic Blood Pressure (Week 88)

Description

Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).

Time Frame

Week -3, week 88

Title

Change in Pulse (Week 35)

Description

Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).

Time Frame

Week -3, week 35

Title

Change in Pulse (Week 88)

Description

Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).

Time Frame

Week -3, week 88

Title

Change in Haemoglobin (Week 34)

Description

Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Haemoglobin (Week 87)

Description

Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Haematocrit (Week 34)

Description

Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Haematocrit (Week 87)

Description

Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Erythrocytes (Week 34)

Description

Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Erythrocytes (Week 87)

Description

Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Mean Corpuscular Volume (MCV) (Week 34)

Description

Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Mean Corpuscular Volume (MCV) (Week 87)

Description

Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)

Description

Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)

Description

Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Thrombocytes (Week 34)

Description

Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Thrombocytes (Week 87)

Description

Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Leucocytes (Week 34)

Description

Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Leucocytes (Week 87)

Description

Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Alanine Aminotransferase (ALT) (Week 34)

Description

Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Alanine Aminotransferase (ALT) (Week 87)

Description

Change in ALT was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Albumin (Week 34)

Description

Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Albumin (Week 87)

Description

Change in Albumin was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Alkaline Phosphatase (ALP) (Week 34)

Description

Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Alkaline Phosphatase (AP) (Week 87)

Description

Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.

Time Frame

Week -3, week 87

Title

Change in Aspartate Aminotransferase (AST) (Week 34)

Description

Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Aspartate Aminotransferase (AST) (Week 87)

Description

Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

Week -3, week 87

Title

Change in Bilirubin (Week 34)

Description

Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Bilirubin (Week 87)

Description

Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Calcium (Week 34)

Description

Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Calcium (Week 87)

Description

Change in Calcium was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Chloride (Week 34)

Description

Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Chloride (Week 87)

Description

Change in Chloride was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Creatinine (Week 34)

Description

Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Creatinine (Week 87)

Description

Change in Creatinine was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Creatine Kinase (Week 34)

Description

Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Creatine Kinase (Week 87)

Description

Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Gamma-glutamyl Transferase (GGT) (Week 34)

Description

Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Gamma-glutamyl Transferase (GGT) (Week 87)

Description

Change in GGT was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Phosphate (Inorganic) (Week 34)

Description

Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Phosphate (Inorganic)(Week 87)

Description

Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Potassium (Week 34)

Description

Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Potassium (Week 87)

Description

Change in Potassium was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Sodium (Week 34)

Description

Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Sodium (Week 87)

Description

Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Total Protein (Week 34)

Description

Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Total Protein (Week 87)

Description

Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Urea (Week 34)

Description

Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Urea (Week 87)

Description

Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Uric Acid (Week 34)

Description

Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Uric Acid (Week 87)

Description

Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)

Description

Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)

Description

Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Fasting Plasma Glucose (Week 34)

Description

Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Fasting Plasma Glucose (Week 87)

Description

Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Fasting Insulin (Week 34)

Description

Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Fasting Insulin (Week 87)

Description

Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Steady State Beta Cell Function (%B) (Week 34)

Description

Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Steady State Beta Cell Function (%B) (Week 87)

Description

Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.

Time Frame

week -3, week 87

Title

Change in Insulin Resistance (IR %) (Week 34)

Description

Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Insulin Resistance (IR %) (Week 87)

Description

Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

Title

Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)

Description

Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time Frame

Week -3, week 34

Title

Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)

Description

Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time Frame

week -3, week 87

10. Eligibility

Sex

All

Minimum Age & Unit of Time

23 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included) If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator FOR ALL COUNTRIES EXCEPT JAPAN: Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test): Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L) Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2, a peak GH less than 4 ng/mL (4 mcg/L) Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria): a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard) Exclusion Criteria: Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure' (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

East Lansing

State/Province

Michigan

ZIP/Postal Code

48824

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-4120

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89511

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79935

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Shavano Park

State/Province

Texas

ZIP/Postal Code

78231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122-5789

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Coffs Harbour

State/Province

New South Wales

ZIP/Postal Code

2450

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01228-000

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

13352

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500034

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560034

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682041

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400008

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Dehli

State/Province

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chandigarh

State/Province

Punjab

ZIP/Postal Code

160012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Telengana

ZIP/Postal Code

500033

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700032

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Petah-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Bunkyo-ku, Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chiba-shi, Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukuoka-shi, Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hamamatsu-shi, Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Itabashi-ku, Tokyo

ZIP/Postal Code

173-8606

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kagoshima

ZIP/Postal Code

890-8520

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kyoto-shi Kyoto

ZIP/Postal Code

612-8555

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Minato-ku, Tokyo

ZIP/Postal Code

105-8470

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Okayama, Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sagamihara-shi, Kanagawa

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sapporo, Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sappro-shi, Hokkaido

ZIP/Postal Code

060 8648

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

134-0088

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Yamagata-shi, Yamagata

ZIP/Postal Code

990-9585

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Yokohama, Kanagawa

ZIP/Postal Code

222-0036

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Kuching

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Pulau Pinang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Putrajaya

ZIP/Postal Code

62250

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0027

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Krakow

ZIP/Postal Code

31-455

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

50-311

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Cluj Napoca

State/Province

Cluj

ZIP/Postal Code

400349

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Targu Mures

State/Province

Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Bucuresti

ZIP/Postal Code

011863

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Iasi

ZIP/Postal Code

700111

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Sibiu

ZIP/Postal Code

550166

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Timisoara

ZIP/Postal Code

300736

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Kazan

ZIP/Postal Code

420061

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0044

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Tygerberg

State/Province

Western Cape

ZIP/Postal Code

7505

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Kiev

ZIP/Postal Code

01021

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Hull

ZIP/Postal Code

HU3 2RW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Citations:

PubMed Identifier

32022863

Citation

Johannsson G, Gordon MB, Hojby Rasmussen M, Hakonsson IH, Karges W, Svaerke C, Tahara S, Takano K, Biller BMK. Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1358-76. doi: 10.1210/clinem/dgaa049.

Results Reference

result

PubMed Identifier

36380045

Citation

Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

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Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. (REAL 1)

Growth Hormone Disorder, Adult Growth Hormone Deficiency

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial