Status:
TERMINATED
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Metabolism and Nutrition Disorder
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 0070-0002-018...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00665665
Start Date
November 1 2007
End Date
October 1 2008
Last Update
December 23 2016
Active Locations (2)
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1
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47710
2
Novo Nordisk Investigational Site
Madison, Wisconsin, United States, 53704