NCT00665665
Terminated
Phase 1
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers
Overview
- Phase
- Phase 1
- Intervention
- placebo
- Conditions
- Metabolism and Nutrition Disorder
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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 0070-0002-0182 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).
Investigators
Eligibility Criteria
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
Arms & Interventions
A
Intervention: placebo
A
Intervention: NNC 0070-0002-0182
B
Intervention: placebo
B
Intervention: NNC 0070-0002-0182
C
Intervention: placebo
C
Intervention: NNC 0070-0002-0182
D
Intervention: placebo
D
Intervention: NNC 0070-0002-0182
Outcomes
Primary Outcomes
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
Time Frame: after 6 weeks
Secondary Outcomes
- Pharmacokinetics of NNC 0070-0002-0182 and its isomer(at 8 weeks)
- Assessment of changes in food consumption and hunger(at 6 weeks)
- Change in weight, waist and hip measurements and mood(at 6 weeks)
- Change in body composition and resting metabolism(at 6 weeks)
- Intervention arm D only: Change from baseline in body fat (DEXA)(at 6 weeks)
- Intervention arm D only: Change from baseline in indirect calorimetry(at 6 weeks)
- Intervention arm D only: Change in insulin sensitivity (HOMA)(at 6 weeks)
- Intervention arm D only: Change from baseline in adiponectin, hsCRP(at 6 weeks)
- Intervention arm D only: Antibody assessment(at 10 weeks)
Study Sites (1)
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