Clinical trial NCT00500370: A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Official title: A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: exenatide
obesity
diabetes
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-07-12
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: 24 weeks
measure: Change in Waist-to-hip Ratio
timeFrame: 24 weeks
measure: Percentage of Patients Experiencing >=5% Weight Loss
timeFrame: 24 weeks
measure: Change in Total Cholesterol
timeFrame: 24 weeks
measure: Change in High Density Lipoprotein (HDL) Cholesterol
timeFrame: 24 weeks
measure: Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)
timeFrame: 24 weeks
measure: Change in Low Density Lipoprotein (LDL) Cholesterol
timeFrame: 24 weeks
measure: Change in Fasting Serum Glucose
timeFrame: 24 weeks
measure: Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)
timeFrame: 24 weeks
measure: Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)
timeFrame: 24 weeks
measure: Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)
timeFrame: 24 weeks
measure: Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis
timeFrame: 24 weeks
measure: Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)
timeFrame: 24 weeks
measure: Change in High Sensitivity C-reactive Protein (hsCRP)
timeFrame: 24 weeks
measure: Change in Glycosylated Hemoglobin (HbA1c)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Topeka
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Goose Creek
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Renton
country: United States
facility: Research Site
state: Washington
city: Ponce
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: 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.