A Two Part Trial Investigating an Anti-obesity Drug ('2-0453) in Overweight/Obese Male and Female Healthy Volunteers
This study has been terminated.
(See detailed description)
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01044108
First received: January 6, 2010
Last updated: December 6, 2011
Last verified: December 2011
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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 '2-0453 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 |
|---|---|---|
|
Healthy Obesity |
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:
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: '2-0453
Administration of a single subcutaneous (under the skin) dose of '2-0453. 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
Investigators
| Study Director: | Birgit Sehested Hansen, PhD | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| 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 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |
Signs and Symptoms Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013