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

Phase 1

Terminated

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: NNC 0070-0002-0182; Drug: placebo

• Registration Number: NCT00665665
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2016-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	NNC 0070-0002-0182	-
A	placebo	-
B	placebo	-
B	NNC 0070-0002-0182	-
C	placebo	-
C	NNC 0070-0002-0182	-
D	placebo	-
D	NNC 0070-0002-0182	-

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses	after 6 weeks

Secondary Outcome Measures

Name	Time	Method
Change in body composition and resting metabolism	at 6 weeks
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
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Madison, Wisconsin, United States