Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female 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 the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).

Official Title
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Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: NNC 0070-0002-0182
* Drug: placebo
* Drug: NNC 0070-0002-0182
* Drug: NNC 0070-0002-0182
* Drug: NNC 0070-0002-0182


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 30.0-39.0 kg/m2 (obese) Females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy Exclusion Criteria: Clinically significant diseases Blood pressure greater than 140/90 mmHg Evidence of depression Recent diet attempts, treatment with diet drugs (within 3 months) Liposuction or other surgery for weight loss within the last year Evidence of eating disorders (bulimia, binge eating) Restricted diets (Kosher, vegetarian) Smoker or history of drug or alcohol abuse Females of childbearing potential: positive pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 0070-0002-0182<br>* 4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial<br>Drug: placebo<br>* Placebo for s.c. injection<br>|
| Experimental: B<br> | Drug: placebo<br>* Placebo for s.c. injection<br>Drug: NNC 0070-0002-0182<br>* 12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial<br>|
| Experimental: C<br> | Drug: placebo<br>* Placebo for s.c. injection<br>Drug: NNC 0070-0002-0182<br>* 32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial<br>|
| Experimental: D<br> | Drug: placebo<br>* Placebo for s.c. injection<br>Drug: NNC 0070-0002-0182<br>* 60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses |  | after 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of NNC 0070-0002-0182 and its isomer |  | at 8 weeks | 
| Assessment of changes in food consumption and hunger |  | at 6 weeks | 
| Change in weight, waist and hip measurements and mood |  | at 6 weeks | 
| Change in body composition and resting metabolism |  | at 6 weeks | 
| Intervention arm D only: Change in insulin sensitivity (HOMA) |  | at 6 weeks | 
| Intervention arm D only: Change from baseline in body fat (DEXA) |  | at 6 weeks | 
| Intervention arm D only: Change from baseline in indirect calorimetry |  | at 6 weeks | 
| Intervention arm D only: Change from baseline in adiponectin, hsCRP |  | at 6 weeks | 
| Intervention arm D only: Antibody assessment |  | at 10 weeks |