Trial · NCT00500370
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
NCT00500370, Phase 2, Completed, AstraZeneca; results first posted 2009-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients. Trials, record NCT00500370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00500370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
- NCT number
- NCT00500370
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 163 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Obesity
- Interventions
- exenatide, placebo
- First posted
- 2007-07-12
- Last updated
- 2015-04-07
- Results first posted
- 2009-09-04
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Weight | 24 weeks | Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0) |
| Secondary | Change in Body Mass Index (BMI) | 24 weeks | Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0) |
| Secondary | Change in Waist-to-hip Ratio | 24 weeks | Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint. |
| Secondary | Percentage of Patients Experiencing >=5% Weight Loss | 24 weeks | Percentage of exenatide and placebo treated patients experiencing \>=5% weight loss after 24 weeks of treatment (i.e., \[weight at week 0 minus weight at week 24\] divided by weight at week 0 times 100% \>=5%) |
| Secondary | Change in Total Cholesterol | 24 weeks | Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0) |
| Secondary | Change in High Density Lipoprotein (HDL) Cholesterol | 24 weeks | Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0) |
| Secondary | Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) | 24 weeks | Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0) |
| Secondary | Change in Low Density Lipoprotein (LDL) Cholesterol | 24 weeks | Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0) |
| Secondary | Change in Fasting Serum Glucose | 24 weeks | Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0) |
| Secondary | Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | 24 weeks | Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Body Weight | 24 weeks | Intent to Treat population | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Body Mass Index (BMI) | 24 weeks | Intent to Treat population | kg/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Waist-to-hip Ratio | 24 weeks | Intent to Treat population | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Experiencing >=5% Weight Loss | 24 weeks | Intent to Treat population; Last Observation Carried Forward | percentage of patients | NUMBER |
| SECONDARY | Change in Total Cholesterol | 24 weeks | Intent to Treat population; Last Observation Carried Forward | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in High Density Lipoprotein (HDL) Cholesterol | 24 weeks | Intent to Treat population; Last Observation Carried Forward | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) | 24 weeks | Intent to Treat population; Last Observation Carried Forward | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Low Density Lipoprotein (LDL) Cholesterol | 24 weeks | Intent to Treat population; Last Observation Carried Forward | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Serum Glucose | 24 weeks | Intent to Treat population | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | 24 weeks | Intent to Treat population; Last Observation Carried Forward | (mmol*hr)/L | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Body Weight | Group A (Exenatide) | Baseline (Week 0) | 109.48 | Standard Error 2.70 | kg |
| Change in Body Weight | Group B (Placebo) | Baseline (Week 0) | 107.64 | Standard Error 2.61 | kg |
| Change in Body Weight | Group A (Exenatide) | Change at Endpoint (Week 24) | -5.06 | Standard Error 0.49 | kg |
| Change in Body Weight | Group B (Placebo) | Change at Endpoint (Week 24) | -1.61 | Standard Error 0.47 | kg |
| Change in Body Mass Index (BMI) | Group A (Exenatide) | Baseline (Week 0) | 39.64 | Standard Error 0.82 | kg/m^2 |
| Change in Body Mass Index (BMI) | Group B (Placebo) | Baseline (Week 0) | 39.39 | Standard Error 0.79 | kg/m^2 |
| Change in Body Mass Index (BMI) | Group A (Exenatide) | Change at Endpoint (Week 24) | -1.83 | Standard Error 0.18 | kg/m^2 |
| Change in Body Mass Index (BMI) | Group B (Placebo) | Change at Endpoint (Week 24) | -0.58 | Standard Error 0.17 | kg/m^2 |
| Change in Waist-to-hip Ratio | Group A (Exenatide) | Baseline (Week 0) | 0.90 | Standard Error 0.01 | Ratio |
| Change in Waist-to-hip Ratio | Group B (Placebo) | Baseline (Week 0) | 0.90 | Standard Error 0.01 | Ratio |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A (Exenatide) | 80 | |
| Overall Study | STARTED | Group B (Placebo) | 83 | |
| Overall Study | Treatment Start-Baseline (Week 0) | Group A (Exenatide) | 73 | |
| Overall Study | Treatment Start-Baseline (Week 0) | Group B (Placebo) | 79 | |
| Overall Study | Treatment Complete (Week 24) | Group A (Exenatide) | 48 | |
| Overall Study | Treatment Complete (Week 24) | Group B (Placebo) | 54 | |
| Overall Study | COMPLETED | Group A (Exenatide) | 47 | |
| Overall Study | COMPLETED | Group B (Placebo) | 49 | |
| Overall Study | NOT COMPLETED | Group A (Exenatide) | 33 | |
| Overall Study | NOT COMPLETED | Group B (Placebo) | 34 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Group A (Exenatide) | 18 | 73 | |
| other | Nausea | Gastrointestinal disorders | Group B (Placebo) | 3 | 79 | |
| other | Diarrhea | Gastrointestinal disorders | Group A (Exenatide) | 10 | 73 | |
| other | Diarrhea | Gastrointestinal disorders | Group B (Placebo) | 2 | 79 | |
| other | Headache | Nervous system disorders | Group A (Exenatide) | 7 | 73 | |
| other | Headache | Nervous system disorders | Group B (Placebo) | 5 | 79 | |
| other | Sinusitis | Infections and infestations | Group A (Exenatide) | 7 | 73 | |
| other | Sinusitis | Infections and infestations | Group B (Placebo) | 7 | 79 | |
| other | Vomiting | Gastrointestinal disorders | Group A (Exenatide) | 6 | 73 | |
| other | Vomiting | Gastrointestinal disorders | Group B (Placebo) | 1 | 79 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A (Exenatide) | ||
| Total, all-cause mortality | Group B (Placebo) | ||
| Total, other adverse events | Group A (Exenatide) | 60 | 73 |
| Total, other adverse events | Group B (Placebo) | 53 | 79 |
| Total, serious adverse events | Group A (Exenatide) | 0 | 73 |
| Total, serious adverse events | Group B (Placebo) | 0 | 79 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20332357 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A (Exenatide) vs Group B (Placebo): Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis | Trial comparisons |
| Group A (Exenatide) vs Group B (Placebo): Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) | Trial comparisons |
| Group A (Exenatide) vs Group B (Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00500370
GET https://conductscience.org/api/trials/v1/NCT00500370/results?page=2