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

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC 0070-0002-0182
placebo
NNC 0070-0002-0182
NNC 0070-0002-0182
NNC 0070-0002-0182
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A

B

C

D

Arm Description

Outcomes

Primary Outcome Measures

To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses

Secondary Outcome Measures

Pharmacokinetics of NNC 0070-0002-0182 and its isomer
Assessment of changes in food consumption and hunger
Change in weight, waist and hip measurements and mood
Change in body composition and resting metabolism
Intervention arm D only: Change in insulin sensitivity (HOMA)
Intervention arm D only: Change from baseline in body fat (DEXA)
Intervention arm D only: Change from baseline in indirect calorimetry
Intervention arm D only: Change from baseline in adiponectin, hsCRP
Intervention arm D only: Antibody assessment

Full Information

First Posted
April 23, 2008
Last Updated
December 22, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00665665
Brief Title
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers
Official Title
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
The trial is terminated due to re-evaluation of the compound
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Title
D
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC 0070-0002-0182
Intervention Description
4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo for s.c. injection
Intervention Type
Drug
Intervention Name(s)
NNC 0070-0002-0182
Intervention Description
12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial
Intervention Type
Drug
Intervention Name(s)
NNC 0070-0002-0182
Intervention Description
32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial
Intervention Type
Drug
Intervention Name(s)
NNC 0070-0002-0182
Intervention Description
60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
Time Frame
after 6 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics of NNC 0070-0002-0182 and its isomer
Time Frame
at 8 weeks
Title
Assessment of changes in food consumption and hunger
Time Frame
at 6 weeks
Title
Change in weight, waist and hip measurements and mood
Time Frame
at 6 weeks
Title
Change in body composition and resting metabolism
Time Frame
at 6 weeks
Title
Intervention arm D only: Change in insulin sensitivity (HOMA)
Time Frame
at 6 weeks
Title
Intervention arm D only: Change from baseline in body fat (DEXA)
Time Frame
at 6 weeks
Title
Intervention arm D only: Change from baseline in indirect calorimetry
Time Frame
at 6 weeks
Title
Intervention arm D only: Change from baseline in adiponectin, hsCRP
Time Frame
at 6 weeks
Title
Intervention arm D only: Antibody assessment
Time Frame
at 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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