GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00500370

CompletedPhase 2Results posted

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

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

163

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00500370

Org study IDH8O-MC-GWBP

Timeline

Milestones

Study first posted2007-07-12estimated

Results first posted2009-09-04estimated

Last update posted2015-04-07estimated

Study start2007-06 (month precision)

Primary completion2008-02actual (month precision)

Study completion2008-02actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

4 endpoints

Primary/protocol endpoint

Change in Body Weight

Time frame:24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Group A (Exenatide)Baseline (Week 0)	109.48	—
Change at Endpoint (Week 24)	-5.06	—
Group B (Placebo)Baseline (Week 0)	107.64	—
Change at Endpoint (Week 24)	-1.61	—

p<0.0001Mixed Model Repeated Measures ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:24 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg/m^2	95% CI
Group A (Exenatide)Baseline (Week 0)	39.64	—
Change at Endpoint (Week 24)	-1.83	—
Group B (Placebo)Baseline (Week 0)	39.39	—
Change at Endpoint (Week 24)	-0.58	—

p<0.0001Mixed Model Repeated Measures ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Change in Waist-to-hip Ratio

Time frame:24 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
Group A (Exenatide)Baseline (Week 0)	0.90	—
Change at Endpoint (Week 24)	-0.001	—
Group B (Placebo)Baseline (Week 0)	0.90	—
Change at Endpoint (Week 24)	0.002	—

p0.6766Mixed Model Repeated Measures ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Percentage of Patients Experiencing >=5% Weight Loss

Time frame:24 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of patients	95% CI
Group A (Exenatide)	31.5	—
Group B (Placebo)	16.5	—

p0.0393Cochran-Mantel-Haenszel

Glycemic / diabetes

7 endpoints

Secondary/protocol endpoint

Change in Fasting Serum Glucose

Time frame:24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Group A (Exenatide)Baseline (Week 0)	5.37	—
Change at Endpoint (Week 24)	0.000	—
Group B (Placebo)Baseline (Week 0)	5.37	—
Change at Endpoint (Week 24)	-0.02	—

p0.8479Mixed Model Repeated Measures ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)

Time frame:24 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), (mmol*hr)/L	95% CI
Group A (Exenatide)Baseline (Week 0)	15.73	—
Change at Endpoint (Week 24)	-0.47	—
Group B (Placebo)Baseline (Week 0)	15.19	—
Change at Endpoint (Week 24)	-0.01	—

p0.2151ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)

Time frame:24 weeks

ratio, improvement

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
Group A (Exenatide)	1.06	—
Group B (Placebo)	1.08	—

p0.7619ANCOVA

Secondary/protocol endpoint

Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)

Time frame:24 weeks

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
Group A (Exenatide)	0.92	—
Group B (Placebo)	0.91	—

p0.8973ANCOVA

Secondary/protocol endpoint

Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis

Time frame:24 weeks

T2DM prevention

threshold achievement, event

Posted result

Group	Value (number), Participants	95% CI
Group A (Exenatide)	3	—
Group B (Placebo)	2	—

p0.6507Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)

Time frame:24 weeks

threshold achievement, improvement

Posted result

Group	Value (number), Participants	95% CI
Group A (Exenatide)	13	—
Group B (Placebo)	9	—

p0.2593Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in Glycosylated Hemoglobin (HbA1c)

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent	95% CI
Group A (Exenatide)Baseline (Week 0)	5.61	—
Change at Endpoint (Week 24)	-0.003	—
Group B (Placebo)Baseline (Week 0)	5.58	—
Change at Endpoint (Week 24)	0.09	—

p0.0293Mixed Model Repeated Measures ANCOVA

Analysis pertains to change at endpoint (Week 24)

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:24 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Group A (Exenatide)Baseline (Week 0)	4.87	—
Change at Endpoint (Week 24)	0.19	—
Group B (Placebo)Baseline (Week 0)	4.88	—
Change at Endpoint (Week 24)	0.33	—

p0.1808ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol

Time frame:24 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Group A (Exenatide)Baseline (Week 0)	1.27	—
Change at Endpoint (Week 24)	0.004	—
Group B (Placebo)Baseline (Week 0)	1.36	—
Change at Endpoint (Week 24)	0.06	—

p0.1204ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)

Time frame:24 weeks

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
Group A (Exenatide)	0.99	—
Group B (Placebo)	0.96	—

p0.6651ANCOVA

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol

Time frame:24 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Group A (Exenatide)Baseline (Week 0)	2.86	—
Change at Endpoint (Week 24)	0.20	—
Group B (Placebo)Baseline (Week 0)	2.79	—
Change at Endpoint (Week 24)	0.34	—

p0.1204ANCOVA

Analysis pertains to change at endpoint (Week 24)

Secondary/protocol endpoint

Change in High Sensitivity C-reactive Protein (hsCRP)

Time frame:24 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
Group A (Exenatide)Baseline (Week 0)	8.61	—
Change at Endpoint (Week 24)	-1.31	—
Group B (Placebo)Baseline (Week 0)	8.03	—
Change at Endpoint (Week 24)	-0.44	—

p0.2919Mixed Model Repeated Measures ANCOVA

Analysis pertains to change at endpoint (Week 24)

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes.
Diabetes care2010 Jun (month)PMID20332357doi:10.2337/dc09-1203via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.