A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
1 other identifier
interventional
163
2 countries
16
Brief Summary
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Jun 2007
Shorter than P25 for phase_2 obesity
16 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
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 10, 2007
CompletedFirst Posted
Study publicly available on registry
July 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
September 4, 2009
CompletedApril 7, 2015
March 1, 2015
8 months
July 10, 2007
February 26, 2009
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Body Weight
Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
24 weeks
Secondary Outcomes (15)
Change in Body Mass Index (BMI)
24 weeks
Change in Waist-to-hip Ratio
24 weeks
Percentage of Patients Experiencing >=5% Weight Loss
24 weeks
Change in Total Cholesterol
24 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
24 weeks
- +10 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALGroup B
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Have a Body Mass Index (BMI) \>= 30kg/m\^2
You may not qualify if:
- Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
- Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for \> 3 months
- Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
- Used drugs for weight loss (e.g., Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Accomplia \[rimonabant\], Alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
- Are actively participating in, or have participated in a formal weight loss program within the last 3 months
- Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
- Have been treated with any anti-diabetic medications within 3 months of screening
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
- Have had bariatric surgery
- Have had an organ transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (16)
Research Site
Peoria, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Santa Ana, California, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Topeka, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
St Louis, Missouri, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Goose Creek, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Renton, Washington, United States
Research Site
Ponce, Puerto Rico
Research Site
San Juan, Puerto Rico
Related Publications (1)
Rosenstock J, Klaff LJ, Schwartz S, Northrup J, Holcombe JH, Wilhelm K, Trautmann M. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care. 2010 Jun;33(6):1173-5. doi: 10.2337/dc09-1203. Epub 2010 Mar 23.
PMID: 20332357DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2007
First Posted
July 12, 2007
Study Start
June 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 7, 2015
Results First Posted
September 4, 2009
Record last verified: 2015-03