Study Stopped
The trial is terminated due to re-evaluation of the compound
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers
1 other identifier
interventional
101
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedDecember 23, 2016
December 1, 2016
11 months
April 23, 2008
December 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
after 6 weeks
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (4)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALD
EXPERIMENTALInterventions
4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Evansville, Indiana, 47710, United States
Novo Nordisk Investigational Site
Madison, Wisconsin, 53704, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 24, 2008
Study Start
November 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
December 23, 2016
Record last verified: 2016-12