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

NCT ID: NCT00665665

Last Updated: 2016-12-23

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-10-31

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).

Detailed Description

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Conditions

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Metabolism and Nutrition Disorder Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

NNC 0070-0002-0182

Intervention Type DRUG

4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial

placebo

Intervention Type DRUG

Placebo for s.c. injection

B

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Placebo for s.c. injection

NNC 0070-0002-0182

Intervention Type DRUG

12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial

C

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Placebo for s.c. injection

NNC 0070-0002-0182

Intervention Type DRUG

32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial

D

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Placebo for s.c. injection

NNC 0070-0002-0182

Intervention Type DRUG

60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial

Interventions

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NNC 0070-0002-0182

4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial

Intervention Type DRUG

placebo

Placebo for s.c. injection

Intervention Type DRUG

NNC 0070-0002-0182

12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial

Intervention Type DRUG

NNC 0070-0002-0182

32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial

Intervention Type DRUG

NNC 0070-0002-0182

60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Evansville, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN9112-1846

Identifier Type: -

Identifier Source: org_study_id