Back to resultsA Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity
Primary Purpose
Metabolism and Nutrition Disorder, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC0194-0499
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorder
Eligibility Criteria
Inclusion Criteria:
- Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
- Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
- Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
- Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
- Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit
Exclusion Criteria:
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
- History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NNC0194-0499
Placebo
Arm Description
Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events (TEAEs)
count of events
Secondary Outcome Measures
Change in heart rate
measured in beats per minute
Change in biochemistry
Parameters: Calcium (total), Chloride, Magnesium, Phosphate (inorganic), Potassium, Sodium, Urea (blood urea nitrogen, BUN), Uric acid, Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Amylase, Aspartate aminotransferase (AST), Creatinine kinase (CK, total), Gamma glutamyltransferase (GGT), Lactase dehydrogenase, Lipase, Albumin, Bicarbonate, Bilirubin (total), Creatinine, High sensitivity C-reactive protein (hsCRP) and Total protein in SI units
Change in haematology
Parameters: Erythrocytes, Reticulocytes, Thrombocytes, Leucocytes (total), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV) and Mean corpuscular haemoglobin concentration (MCHC) in SI units
Change in fibrinogen
measured in g/L
Change in prothrombin time read as international normalised ratio (INR)
Change in activated partial thromboplastin time (APTT)
measured in seconds
Changes in electrocardiogram (ECG)
Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units
Number of injection site reactions
count of injection site reactions
Occurrence of anti-NNC0194-0499 antibodies
t½,SS: the terminal serum half-life of NNC0194-0499 at steady state
Calculated based on serum concentrations of NNC0194-0499
Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state
Calculated based on serum concentrations of NNC0194-0499
tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state
Calculated based on serum concentrations of NNC0194-0499
CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state
Calculated based on serum concentrations of NNC0194-0499
Change in systolic blood pressure
measured in mmHg
Change in diastolic blood pressure
measured in mmHg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03479892
Brief Title
A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity
Official Title
A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC0194-0499
Arm Type
Experimental
Arm Description
Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499
Intervention Description
Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level.
Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive once weekly injections of NNC0194-0499 matched placebo.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAEs)
Description
count of events
Time Frame
From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)
Secondary Outcome Measure Information:
Title
Change in heart rate
Description
measured in beats per minute
Time Frame
Baseline (Day 1), Follow-up (Day 112)
Title
Change in biochemistry
Description
Parameters: Calcium (total), Chloride, Magnesium, Phosphate (inorganic), Potassium, Sodium, Urea (blood urea nitrogen, BUN), Uric acid, Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Amylase, Aspartate aminotransferase (AST), Creatinine kinase (CK, total), Gamma glutamyltransferase (GGT), Lactase dehydrogenase, Lipase, Albumin, Bicarbonate, Bilirubin (total), Creatinine, High sensitivity C-reactive protein (hsCRP) and Total protein in SI units
Time Frame
Baseline (Day -1), Follow-up (Day 112)
Title
Change in haematology
Description
Parameters: Erythrocytes, Reticulocytes, Thrombocytes, Leucocytes (total), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV) and Mean corpuscular haemoglobin concentration (MCHC) in SI units
Time Frame
Baseline (Day -1), Follow-up (Day 112)
Title
Change in fibrinogen
Description
measured in g/L
Time Frame
Baseline (Day -1), Follow-up (Day 112)
Title
Change in prothrombin time read as international normalised ratio (INR)
Time Frame
Baseline (Day -1), Follow-up (Day 112)
Title
Change in activated partial thromboplastin time (APTT)
Description
measured in seconds
Time Frame
Baseline (Day -1), Follow-up (Day 112)
Title
Changes in electrocardiogram (ECG)
Description
Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units
Time Frame
Baseline (Day 1), Follow-up (Day 112)
Title
Number of injection site reactions
Description
count of injection site reactions
Time Frame
From baseline (Day 1) to follow-up (Day 112)
Title
Occurrence of anti-NNC0194-0499 antibodies
Time Frame
From baseline (Day 1) to follow-up (Day 112)
Title
t½,SS: the terminal serum half-life of NNC0194-0499 at steady state
Description
Calculated based on serum concentrations of NNC0194-0499
Time Frame
From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Title
Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state
Description
Calculated based on serum concentrations of NNC0194-0499
Time Frame
From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Title
tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state
Description
Calculated based on serum concentrations of NNC0194-0499
Time Frame
From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Title
CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state
Description
Calculated based on serum concentrations of NNC0194-0499
Time Frame
From last dose (Day 78, pre-dose) until the follow-up (Day 112)
Title
Change in systolic blood pressure
Description
measured in mmHg
Time Frame
Baseline (Day 1), Follow-up (Day 112)
Title
Change in diastolic blood pressure
Description
measured in mmHg
Time Frame
Baseline (Day 1), Follow-up (Day 112)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit
Exclusion Criteria:
Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
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
http://www.novonordisk-trials.com
Learn more about this trial
A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity
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