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

This study has been terminated.
(The trial is terminated due to re-evaluation of the compound)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00665665
First received: April 23, 2008
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Metabolism and Nutrition Disorder
Obesity
Drug: NNC 0070-0002-0182
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses [ Time Frame: after 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of NNC 0070-0002-0182 and its isomer [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
  • Assessment of changes in food consumption and hunger [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Change in weight, waist and hip measurements and mood [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Change in body composition and resting metabolism [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Intervention arm D only: Change in insulin sensitivity (HOMA) [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Intervention arm D only: Change from baseline in body fat (DEXA) [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Intervention arm D only: Change from baseline in indirect calorimetry [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Intervention arm D only: Change from baseline in adiponectin, hsCRP [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Intervention arm D only: Antibody assessment [ Time Frame: at 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NNC 0070-0002-0182
4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial
Drug: placebo
Placebo for s.c. injection
Experimental: B Drug: placebo
Placebo for s.c. injection
Drug: NNC 0070-0002-0182
12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial
Experimental: C Drug: placebo
Placebo for s.c. injection
Drug: NNC 0070-0002-0182
32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial
Experimental: D Drug: placebo
Placebo for s.c. injection
Drug: NNC 0070-0002-0182
60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665665

Locations
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47710
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: William Lyness, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00665665     History of Changes
Other Study ID Numbers: NN9112-1846
Study First Received: April 23, 2008
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014