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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-05

Study Completion Date

2011-09-20

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.

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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.

Conditions

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Metabolism and Nutrition Disorder Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Trial, part 1 (males only)

Group Type EXPERIMENTAL

NNC 0070-0002-0453

Intervention Type DRUG

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.

placebo

Intervention Type DRUG

Placebo will be administered as a comparator at each dose level.

Trial, part 2 (males and females)

Group Type EXPERIMENTAL

'2-0453

Intervention Type DRUG

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.

placebo

Intervention Type DRUG

Placebo will be administered as a comparator at each dose level.

Interventions

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NNC 0070-0002-0453

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.

Intervention Type DRUG

'2-0453

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.

Intervention Type DRUG

placebo

Placebo will be administered as a comparator at each dose level.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes