Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers

Study Overview
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Brief Summary
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This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated. Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated. Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.

Official Title
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Single Subcutaneous Dose Rising Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0349 in Overweight/Obese Male Subjects

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: NNC 0070-0002-0349
* Drug: NNC 0070-0002-0349
* Drug: NNC 0070-0002-0349
* Drug: NNC 0070-0002-0349
* Drug: NNC 0070-0002-0349
* Drug: placebo
* Drug: placebo
* Drug: placebo
* Drug: placebo
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI greater than 27.0 and less than 35.0 kg/m2 Exclusion Criteria: Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item) Eating disorders Unusual diets or eating habits Dieting, use of diet drugs or obesity surgery Diabetes history or abnormal fasting glucose

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: NNC 0070-0002-0349<br>* Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo<br>Drug: placebo<br>* Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo<br>|
| Experimental: B<br> | Drug: NNC 0070-0002-0349<br>* Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo<br>Drug: placebo<br>* Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo<br>|
| Experimental: C<br> | Drug: NNC 0070-0002-0349<br>* Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo<br>Drug: placebo<br>* Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo<br>|
| Experimental: D<br> | Drug: NNC 0070-0002-0349<br>* Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo)<br>Drug: placebo<br>* Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection<br>|
| Experimental: E<br> | Drug: NNC 0070-0002-0349<br>* Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo)<br>Drug: placebo<br>* Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG) |  | Including screening and evaluation: after approx. 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the curve) |  | 21 days following dosing | 
| Maximum plasma concentration |  | 21 days following dosing | 
| Time to maximum plasma concentration |  | 21 days following dosing | 
| Half life |  | 21 days following dosing |