A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: NNC0194-0499; Drug: Placebo

• Registration Number: NCT03479892
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-09
• Study Start: 2018-03-13
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-03-27
• Status Verified: 2019-06
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0194-0499	NNC0194-0499	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)	count of events

Secondary Outcome Measures

Name	Time	Method
Change in fibrinogen	Baseline (Day -1), Follow-up (Day 112)	measured in g/L
Occurrence of anti-NNC0194-0499 antibodies	From baseline (Day 1) to follow-up (Day 112)
Change in haematology	Baseline (Day -1), Follow-up (Day 112)	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 activated partial thromboplastin time (APTT)	Baseline (Day -1), Follow-up (Day 112)	measured in seconds
Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state	From last dose (Day 78, pre-dose) until the follow-up (Day 112)	Calculated based on serum concentrations of NNC0194-0499
tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state	From last dose (Day 78, pre-dose) until the follow-up (Day 112)	Calculated based on serum concentrations of NNC0194-0499
Change in heart rate	Baseline (Day 1), Follow-up (Day 112)	measured in beats per minute
t½,SS: the terminal serum half-life of NNC0194-0499 at steady state	From last dose (Day 78, pre-dose) until the follow-up (Day 112)	Calculated based on serum concentrations of NNC0194-0499
CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state	From last dose (Day 78, pre-dose) until the follow-up (Day 112)	Calculated based on serum concentrations of NNC0194-0499
Change in biochemistry	Baseline (Day -1), Follow-up (Day 112)	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 prothrombin time read as international normalised ratio (INR)	Baseline (Day -1), Follow-up (Day 112)
Changes in electrocardiogram (ECG)	Baseline (Day 1), Follow-up (Day 112)	Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units
Change in diastolic blood pressure	Baseline (Day 1), Follow-up (Day 112)	measured in mmHg
Number of injection site reactions	From baseline (Day 1) to follow-up (Day 112)	count of injection site reactions
Change in systolic blood pressure	Baseline (Day 1), Follow-up (Day 112)	measured in mmHg

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 San Antonio, Texas, United States