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A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (REAL4)

Primary Purpose

Growth Hormone Deficiency in Children

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Somapacitan

Norditropin®

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency in Children

Eligibility Criteria

undefined - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue)
Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard
Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
No prior exposure to growth hormone therapy or IGF-I treatment

Exclusion Criteria:

Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
Diagnosis of attention deficit hyperactivity disorder
Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder
Prior history or presence of malignancy including intracranial tumours

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Somapacitan weekly

Norditropin® daily

Arm Description

Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).

Participants will receive Norditropin® daily for 52 weeks (main trial period).

Outcomes

Primary Outcome Measures

Height Velocity: In-trial Observation Period

Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Height Velocity: On-treatment Observation Period

Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.

Secondary Outcome Measures

Change in Bone Age

Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Change in Height Standard Deviation Score (HSDS)

Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Change in Height Velocity Standard Deviation Score (HV SDS)

Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Change in Fasting Plasma Glucose (FPG) at Week 52

Change from baseline (week -2) in FPG at week 52 is presented.

Change in FPG at Week 104

Change in FPG at Week 156

Change in FPG at Week 208

Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52

Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

Change in HOMA-B at Week 104

Change in HOMA-B at Week 156

Change in HOMA-B at Week 208

Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52

Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) * 1/6(µU/mL) * FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

Change in HOMA-IR at Week 104

Change in HOMA-IR at Week 156

Change in HOMA-IR at Week 208

Change in Glycated Haemoglobin (HbA1c) at Week 52

Change from baseline (week -2) in HbA1c at week 52 is presented.

Change in HbA1c at Week 104

Change in HbA1c at Week 156

Change in HbA1c at Week 208

Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52

Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Change in IGF-I SDS at Week 104

Change in IGF-I SDS at Week 156

Change in IGF-I SDS at Week 208

Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52

Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Change in IGFBP-3 SDS at Week 104

Change in IGFBP-3 SDS at Week 156

Change in IGFBP-3 SDS at Week 208

Full Information

NCT ID

NCT03811535

First Posted

January 18, 2019

Last Updated

September 21, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03811535

Brief Title

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

Acronym

REAL4

Official Title

A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 20, 2019 (Actual)

Primary Completion Date

November 10, 2021 (Actual)

Study Completion Date

September 30, 2025 (Anticipated)

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

Yes

5. Study Description

Brief Summary

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

6. Conditions and Keywords

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

Growth Hormone Deficiency in Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Participants will receive either somapacitan once weekly or Norditropin® once daily for 52 weeks (main trial period). All participants completing the main trial period will receive somapacitan weekly for 3 years (extension trial period).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Somapacitan weekly

Arm Type

Experimental

Arm Description

Arm Title

Norditropin® daily

Arm Type

Active Comparator

Arm Description

Participants will receive Norditropin® daily for 52 weeks (main trial period).

Intervention Type

Drug

Intervention Name(s)

Somapacitan

Intervention Description

Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

Intervention Type

Drug

Intervention Name(s)

Norditropin®

Intervention Description

Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.

Primary Outcome Measure Information:

Title

Height Velocity: In-trial Observation Period

Description

Time Frame

From baseline (week 0) to visit 7 (week 52)

Title

Height Velocity: On-treatment Observation Period

Description

Time Frame

From baseline (week 0) to visit 7 (week 52)

Secondary Outcome Measure Information:

Title

Change in Bone Age

Description

Time Frame

Baseline (week -2), week 52

Title

Change in Height Standard Deviation Score (HSDS)

Description

Time Frame

Baseline (week 0), week 52

Title

Change in Height Velocity Standard Deviation Score (HV SDS)

Description

Time Frame

Baseline (week 0), week 52

Title

Change in Fasting Plasma Glucose (FPG) at Week 52

Description

Change from baseline (week -2) in FPG at week 52 is presented.

Time Frame

Baseline (week -2), week 52

Title

Change in FPG at Week 104

Time Frame

Baseline (week -2), week 104

Title

Change in FPG at Week 156

Time Frame

Baseline (week -2), week 156

Title

Change in FPG at Week 208

Time Frame

Baseline (week -2), week 208

Title

Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52

Description

Time Frame

Baseline (week -2), week 52

Title

Change in HOMA-B at Week 104

Time Frame

Baseline (week -2), week 104

Title

Change in HOMA-B at Week 156

Time Frame

Baseline (week -2), week 156

Title

Change in HOMA-B at Week 208

Time Frame

Baseline (week -2), week 208

Title

Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52

Description

Time Frame

Baseline (week -2), week 52

Title

Change in HOMA-IR at Week 104

Time Frame

Baseline (week -2), week 104

Title

Change in HOMA-IR at Week 156

Time Frame

Baseline (week -2), week 156

Title

Change in HOMA-IR at Week 208

Time Frame

Baseline (week -2), week 208

Title

Change in Glycated Haemoglobin (HbA1c) at Week 52

Description

Change from baseline (week -2) in HbA1c at week 52 is presented.

Time Frame

Baseline (week -2), week 52

Title

Change in HbA1c at Week 104

Time Frame

Baseline (week -2), week 104

Title

Change in HbA1c at Week 156

Time Frame

Baseline (week -2), week 156

Title

Change in HbA1c at Week 208

Time Frame

Baseline (week -2), week 208

Title

Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52

Description

Time Frame

Baseline (week 0), week 52

Title

Change in IGF-I SDS at Week 104

Time Frame

Baseline (week 0), week 104

Title

Change in IGF-I SDS at Week 156

Time Frame

Baseline (week 0), week 156

Title

Change in IGF-I SDS at Week 208

Time Frame

Baseline (week 0), week 208

Title

Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52

Description

Time Frame

Baseline (week 0), week 52

Title

Change in IGFBP-3 SDS at Week 104

Time Frame

Baseline (week 0), week 104

Title

Change in IGFBP-3 SDS at Week 156

Time Frame

Baseline (week 0), week 156

Title

Change in IGFBP-3 SDS at Week 208

Time Frame

Baseline (week 0), week 208

10. Eligibility

Sex

All

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue) Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory No prior exposure to growth hormone therapy or IGF-I treatment Exclusion Criteria: Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening Diagnosis of attention deficit hyperactivity disorder Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder Prior history or presence of malignancy including intracranial tumours

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Transparency (dept. 2834)

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

90027

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greenwood Village

State/Province

Colorado

ZIP/Postal Code

80111-2803

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19803

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

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

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78723

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Algiers

ZIP/Postal Code

16000

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Constantine

ZIP/Postal Code

25000

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

A 5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

St. Poelten

ZIP/Postal Code

A 3100

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

ANGERS cedex 09

ZIP/Postal Code

49033

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Le Kremlin-bicetre

ZIP/Postal Code

94275

Country

France

Facility Name

Novo Nordisk Investigational Site

City

MARSEILLE Cédex 05

ZIP/Postal Code

13385

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682041

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

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

Dublin

ZIP/Postal Code

D12 N512

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah Tikva

ZIP/Postal Code

49202

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Genova

ZIP/Postal Code

16147

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Roma

ZIP/Postal Code

00165

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Fukuoka-shi, Fukuoka

ZIP/Postal Code

813-0017

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukuyama-shi, Hiroshima

ZIP/Postal Code

720-8520

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukuyama-shi, Hiroshima

ZIP/Postal Code

721-8511

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Mito, Ibaraki

ZIP/Postal Code

311-4145

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Nara-shi, Nara

ZIP/Postal Code

630-8581

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Obu-shi, Aichi

ZIP/Postal Code

474-8710

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Okayama-shi, Okayama

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka

ZIP/Postal Code

594-1101

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suita-shi, Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

157 8535

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Busan

ZIP/Postal Code

47392

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV1004

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Szczecin

ZIP/Postal Code

71-252

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Izhevsk

ZIP/Postal Code

426009

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

Moscow

ZIP/Postal Code

125373

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630048

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Rostov-on-Don

ZIP/Postal Code

344013

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191144

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Samara

ZIP/Postal Code

443079

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

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11070

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Ljubljana

ZIP/Postal Code

1525

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Esplugues Llobregat(Barcelona)

ZIP/Postal Code

08950

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Kharkiv

ZIP/Postal Code

61000

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Vinnytsia

ZIP/Postal Code

21010

Country

Ukraine

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Hull

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Liverpool

ZIP/Postal Code

L12 2AP

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Tooting

ZIP/Postal Code

SW17 0RE

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

IPD Sharing URL

https://www.novonordisk-trials.com

Citations:

PubMed Identifier

36062966

Citation

Miller BS, Blair JC, Rasmussen MH, Maniatis A, Kildemoes RJ, Mori J, Polak M, Bang RB, Bottcher V, Stagi S, Horikawa R. Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3378-3388. doi: 10.1210/clinem/dgac513.

Results Reference

derived

Learn more about this trial

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

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A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (REAL4)

Growth Hormone Deficiency in Children

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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