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

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

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).

Study Overview

• Status: Terminated
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: NNC 0070-0002-0182; Drug: placebo; Drug: NNC 0070-0002-0182; Drug: NNC 0070-0002-0182; Drug: NNC 0070-0002-0182

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Drug: NNC 0070-0002-0182; 12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial
Experimental: B	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; Drug: NNC 0070-0002-0182; 12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial
Experimental: C	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; Drug: NNC 0070-0002-0182; 12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial
Experimental: D	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; Drug: NNC 0070-0002-0182; 12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial; Drug: NNC 0070-0002-0182; 60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses	after 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 in insulin sensitivity (HOMA)	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 from baseline in adiponectin, hsCRP	at 6 weeks
Intervention arm D only: Antibody assessment	at 10 weeks

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: April 23, 2008
• First Posted (Estimate): April 24, 2008

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Nutrition Disorders
• Other Study ID Numbers: NN9112-1846