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ObesityPhase 2NCT00500370

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

A Phase 2 study testing exenatide in people with Obesity, run by AstraZeneca at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
exenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
163 participants
Where
16 sitesin 2 countries
Study dates
Jun 2007to Feb 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States14 sites

  • Research Site

    Baton Rouge, Louisiana

  • Research Site

    Dallas, Texas

  • Research Site

    Goose Creek, South Carolina

  • Research Site

    Indianapolis, Indiana

  • Research Site

    Oklahoma City, Oklahoma

  • Research Site

    Peoria, Arizona

  • Research Site

    Renton, Washington

  • Research Site

    San Antonio, Texas

  • Research Site

    Santa Ana, California

  • Research Site

    Spartanburg, South Carolina

  • Research Site

    St Louis, Missouri

  • Research Site

    Topeka, Kansas

  • Research Site

    Tucson, Arizona

  • Research Site

    Wichita, Kansas

Other trials in United States

Puerto Rico2 sites

  • Research Site

    Ponce

  • Research Site

    San Juan

Other trials in Puerto Rico

About this study

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.

Conditions
Obesity
Being tested
exenatide, placebo
Keywords
exenatide, obesity, diabetes, Amylin, Lilly
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exenatideDrug

    Also called Byetta

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

  • placeboDrug

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

Study groups in NCT00500370
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: exenatide
Group BPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24 weeks

Secondary outcomes (15)

  1. Change in Body Mass Index (BMI)

    Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)

    Measured: 24 weeks

  2. Change in Waist-to-hip Ratio

    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.

    Measured: 24 weeks

  3. Percentage of Patients Experiencing >=5% Weight Loss

    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%)

    Measured: 24 weeks

  4. Change in Total Cholesterol

    Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

    Measured: 24 weeks

  5. Change in High Density Lipoprotein (HDL) Cholesterol

    Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)

    Measured: 24 weeks

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

    Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)

    Measured: 24 weeks

  7. Change in Low Density Lipoprotein (LDL) Cholesterol

    Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)

    Measured: 24 weeks

  8. Change in Fasting Serum Glucose

    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)

    Measured: 24 weeks

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

    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)

    Measured: 24 weeks

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

    Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.

    Measured: 24 weeks

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

    Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.

    Measured: 24 weeks

  12. Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis

    Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24

    Measured: 24 weeks

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

    Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24

    Measured: 24 weeks

  14. Change in High Sensitivity C-reactive Protein (hsCRP)

    Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)

    Measured: 24 weeks

  15. Change in Glycosylated Hemoglobin (HbA1c)

    Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00500370
Sponsor's protocol ID
H8O-MC-GWBP
Status last verified
Mar 2015
First submitted
10 Jul 2007
Last updated
7 Apr 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 20332357

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing exenatide in people with Obesity, run by AstraZeneca at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Weight (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00500370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

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