Back to resultsA Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers
Primary Purpose
Metabolism and Nutrition Disorder, Obesity
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC 0070-0002-0453
'2-0453
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorder
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Trial, part 1 (males only)
Trial, part 2 (males and females)
Arm Description
Outcomes
Primary Outcome Measures
Number and severity of adverse events
Secondary Outcome Measures
Terminal half-life (t½)
AUC 0-24h, area under the '2-453 concentration-time curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01044108
Brief Title
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
See detailed description
Study Start Date
January 5, 2010 (Actual)
Primary Completion Date
December 13, 2010 (Actual)
Study Completion Date
September 20, 2011 (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 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.
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.
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
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial, part 1 (males only)
Arm Type
Experimental
Arm Title
Trial, part 2 (males and females)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC 0070-0002-0453
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
'2-0453
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo will be administered as a comparator at each dose level.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Terminal half-life (t½)
Time Frame
After administration of a single dose of trial drug
Title
AUC 0-24h, area under the '2-453 concentration-time curve
Time Frame
From 0 to 24 hours after steady state
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers
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