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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00665665

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.

Condition	Intervention	Phase
Obesity	Drug: NNC 0070-0002-0182 Drug: placebo	Phase I Phase II

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers

Further study details as provided by Novo Nordisk:

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:	60
Study Start Date:	April 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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
B: Experimental	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
C: Experimental	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
D: Experimental	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

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

Investigators

Study Director:

William Lyness, PhD

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN9112-1846
Study First Received:	April 23, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00665665
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overnutrition
Overweight
Healthy

ClinicalTrials.gov processed this record on January 16, 2009