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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00665665
• Other study ID #: NN9112-1846
• Status: Terminated
• Phase: Phase 1
• First received: April 23, 2008
• Last updated: December 22, 2016
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• NNC 0070-0002-0182
4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial
• placebo
Placebo for s.c. injection
• NNC 0070-0002-0182
12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial
• NNC 0070-0002-0182
32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial
• NNC 0070-0002-0182
60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Evansville	Indiana
United States	Novo Nordisk Investigational Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses		after 6 weeks	Yes
Secondary	Pharmacokinetics of NNC 0070-0002-0182 and its isomer		at 8 weeks	No
Secondary	Assessment of changes in food consumption and hunger		at 6 weeks	No
Secondary	Change in weight, waist and hip measurements and mood		at 6 weeks	No
Secondary	Change in body composition and resting metabolism		at 6 weeks	No
Secondary	Intervention arm D only: Change in insulin sensitivity (HOMA)		at 6 weeks	No
Secondary	Intervention arm D only: Change from baseline in body fat (DEXA)		at 6 weeks	No
Secondary	Intervention arm D only: Change from baseline in indirect calorimetry		at 6 weeks	No
Secondary	Intervention arm D only: Change from baseline in adiponectin, hsCRP		at 6 weeks	No
Secondary	Intervention arm D only: Antibody assessment		at 10 weeks	Yes

External Links

•   Clinical Trials at Novo Nordisk