A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

NCT ID: NCT00500370

Last Updated: 2015-04-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection (5mcg or 10mcg), twice a day

Group B

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subcutaneous injection (equivalent volume to active dose), twice a day

Interventions

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exenatide

subcutaneous injection (5mcg or 10mcg), twice a day

Intervention Type DRUG

placebo

subcutaneous injection (equivalent volume to active dose), twice a day

Intervention Type DRUG

Other Intervention Names

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Byetta

Eligibility Criteria

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Inclusion Criteria

* Have a Body Mass Index (BMI) \>= 30kg/m\^2

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Malone, MD

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Research Site

Peoria, Arizona, United States

Site Status

Research Site

Tucson, Arizona, United States

Site Status

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Santa Ana, California, United States

Site Status

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Indianapolis, Indiana, United States

Site Status

Research Site

Topeka, Kansas, United States

Site Status

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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St Louis, Missouri, United States

Site Status

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Oklahoma City, Oklahoma, United States

Site Status

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Goose Creek, South Carolina, United States

Site Status

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Spartanburg, South Carolina, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Renton, Washington, United States

Site Status

Research Site

Ponce, , Puerto Rico

Site Status

Research Site

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 20332357 (View on PubMed)

Other Identifiers

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H8O-MC-GWBP

Identifier Type: -

Identifier Source: org_study_id

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