A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers

Study Overview
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Brief Summary
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This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.

Detailed Description
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Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Two Part Trial (Sequential Single Subcutaneous Dose Rising Trial and Semi-Sequential Multiple Subcutaneous Dose Response Trial) to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0453 in Overweight/Obese Male and Female Subjects

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: NNC 0070-0002-0453
* Drug: '2-0453
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FOR TRIAL PART 1, THE FOLLOWING APPLIES: Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2 Good general health FOR TRIAL PART 2, THE FOLLOWING APPLIES: Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject. Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2 Good general health. Exclusion Criteria: Aggressive diet attempts within the last 3 months Current or history of treatment with medications that may cause significant weight gain History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour History of eating disorders Any weight change of 5 kg (11 pounds) in the last 3 months Tobacco use History of alcoholism or drug/chemical abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial, part 1 (males only)<br> | Drug: NNC 0070-0002-0453<br>* Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.<br>Drug: placebo<br>* Placebo will be administered as a comparator at each dose level.<br>|
| Experimental: Trial, part 2 (males and females)<br> | Drug: '2-0453<br>* Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.<br>Drug: placebo<br>* Placebo will be administered as a comparator at each dose level.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of adverse events |  | From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal half-life (t½) |  | After administration of a single dose of trial drug | 
| AUC 0-24h, area under the '2-453 concentration-time curve |  | From 0 to 24 hours after steady state |