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



Status:Terminated
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:12/24/2016
Start Date:November 2007
End Date:October 2008

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).


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
We found this trial at
2
sites
Novo Nordisk Investigational Site
Madison, Wisconsin 53792
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Madison, WI
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Novo Nordisk Investigational Site
Evansville, Indiana 47714
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Evansville, IN
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