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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blinded, Multiple-dose, Dose-escalation Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Subjects With Overweight or Obesity

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: NNC0194-0499
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0194-0499<br>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. | Drug: NNC0194-0499<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Participants will receive once weekly injections of NNC0194-0499 matched placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events (TEAEs) | count of events | From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112) | 

Secondary Outcome Measures

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