A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers

This study has been terminated.
(See detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01044108
First received: January 6, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.


Condition Intervention Phase
Metabolism and Nutrition Disorder
Obesity
Healthy
Drug: NNC 0070-0002-0453
Drug: '2-0453
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Two Part Trial (Sequential Single Subcutaneous Dose Rising Trial and Semi-Sequential Multiple Subcutaneous Dose Response Trial) to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0453 in Overweight/Obese Male and Female Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number and severity of adverse events [ Time Frame: From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Terminal half-life (t½) [ Time Frame: After administration of a single dose of trial drug ] [ Designated as safety issue: No ]
  • AUC 0-24h, area under the '2-453 concentration-time curve [ Time Frame: From 0 to 24 hours after steady state ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trial, part 1 (males only) Drug: NNC 0070-0002-0453
Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
Drug: placebo
Placebo will be administered as a comparator at each dose level.
Experimental: Trial, part 2 (males and females) Drug: '2-0453
Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
Drug: placebo
Placebo will be administered as a comparator at each dose level.

Detailed Description:

Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • FOR TRIAL PART 1, THE FOLLOWING APPLIES:
  • Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject
  • Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2
  • Good general health
  • FOR TRIAL PART 2, THE FOLLOWING APPLIES:
  • Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject.
  • Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2
  • Good general health.

Exclusion Criteria:

  • Aggressive diet attempts within the last 3 months
  • Current or history of treatment with medications that may cause significant weight gain
  • History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour
  • History of eating disorders
  • Any weight change of 5 kg (11 pounds) in the last 3 months
  • Tobacco use
  • History of alcoholism or drug/chemical abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044108

Locations
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01044108     History of Changes
Other Study ID Numbers: NN9161-3749, U1111-1112-7351
Study First Received: January 6, 2010
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nutrition Disorders
Obesity
Overweight
Overnutrition
Body Weight
Signs and Symptoms
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014