Morbid ObesityPhase 2/3AGREENCT00872378
The Effects of Exenatide After Gastric Restriction
A Phase 2/3 study testing Exenatide in people with Morbid Obesity, run by Advanced Specialty Care at 2 sites in United States.
Trial summary
The purpose of this study is to describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or placebo injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Exenatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years,
- Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery),
- For women of childbearing age, must have a negative pregnancy test at screening, and agree to use barrier contraceptives for the duration of the study, AND
- Are able to understand and comply with the study process, and give informed consent.
Who cannot join
- A diagnosis of type 1 diabetes mellitus,
- A diagnosis of type 2 diabetes mellitus (A diagnosis of T2DM will be a previous fasting plasma glucose greater than or equal to 126 mg/dL, or a random plasma glucose greater than 200 mg/dL),
- Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide),
- Patients with end stage renal disease or severe renal impairment,
- Patients with severe gastrointestinal disease, including gastroparesis,
- Liver function tests 2.5 standard deviations above normal values,
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- Contraindication for bariatric surgery,
- Treatment with exenatide (Byetta) in the last three months,
- Currently using or have used within three months before this trial: sibutramine, orlistat, or phentermine(patients must also agree to not use these medications for the duration of the study),
- Treatment with any investigational drug in the last 30 days,
- Active malignancy, liver of kidney failure, symptomatic coronary heart disease, or severe psychiatric disease,
- History of malignancy other than basal cell skin carcinoma, OR
- In the opinion of the investigator, patient is abusing alcohol and/or drugs.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Advanced Specialty Care
Bend, Oregon, 97701
Megan E Boone, BS, 541-322-1772, megan@advancedspecialtycare.com
Ngocthuy Hughes, MD
- Recruiting
Endocrinology Services NorthWest
Bend, Oregon, 97701
Megan E Boone, BS, 541-322-1772, megan@advancedspecialtycare.com
Patrick J McCarthy, MD
About this study
Official title: A Pilot Study of the Effects of BYETTA® (Exenatide) on Weight Loss in Morbidly Obese Non Diabetic Patients Following Adjustable Gastric Banding
The purpose of this study is to describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or placebo injections.
- Conditions
- Morbid Obesity
- Being tested
- Exenatide, Placebo
- Keywords
- Morbid Obesity, LAP Band, Adjustable Gastric Band, Exenatide, Byetta, Weight Loss, Bariatric Surgery
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called BYETTA
Exenatide titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID).
PlaceboDrug
Placebo titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID).
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Active comparator | Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program Receives: Drug: Exenatide |
| Placebo | Placebo comparator | Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan.
Measured: 52 weeks
Secondary outcomes (4)
Body Mass Index (BMI)
Measured: 52 Weeks
Waist circumference
Measured: 52 Weeks
Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c
Measured: 52 Weeks
Carotid intima media thickness(CIMT)
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Specialty Care
- Sponsor type
- University, hospital or other
- Investigators
- Patrick J McCarthy, M.D., Principal investigator, Endocrinology Services NorthWest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872378
- Sponsor's protocol ID
- ASC-AGREE Study
- Acronym
- AGREE
- Status last verified
- Mar 2009
- First submitted
- 27 Mar 2009
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of BYETTA® (Exenatide) on Weight Loss in Morbidly Obese Non Diabetic Patients Following Adjustable Gastric Banding
- ClinicalTrials.gov ID
- NCT00872378
- Acronym / sponsor ID
- AGREE / ASC-AGREE Study
- Conditions
- Morbid Obesity
- Keywords
- Morbid Obesity, LAP Band, Adjustable Gastric Band, Exenatide, Byetta, Weight Loss, Bariatric Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Advanced Specialty CareUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or placebo injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Active comparator | Drug: ExenatideLaparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program |
| Placebo | Placebo comparator | Drug: PlaceboLaparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years,
- Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery),
- For women of childbearing age, must have a negative pregnancy test at screening, and agree to use barrier contraceptives for the duration of the study, AND
- Are able to understand and comply with the study process, and give informed consent.
Key exclusion criteria (13 listed)
- A diagnosis of type 1 diabetes mellitus,
- A diagnosis of type 2 diabetes mellitus (A diagnosis of T2DM will be a previous fasting plasma glucose greater than or equal to 126 mg/dL, or a random plasma glucose greater than 200 mg/dL),
- Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide),
- Patients with end stage renal disease or severe renal impairment,
- Patients with severe gastrointestinal disease, including gastroparesis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: BYETTAExenatide titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID). | Drug | Exenatide |
| PlaceboPlacebo titrated up to 20mcg BID. (4 weeks at 5mcg BID; 4 weeks at 10mcg BID; 4 weeks at 15mcg BID; 37 weeks at 20mcg BID). | Drug | Placebo |
Primary outcome
To describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan.
Time frame: 52 weeks
4 secondary outcomes
Body Mass Index (BMI)
Time frame: 52 Weeks
Waist circumference
Time frame: 52 Weeks
Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c
Time frame: 52 Weeks
Carotid intima media thickness(CIMT)
Time frame: 52 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J McCarthy, M.D. principal investigator
Endocrinology Services NorthWest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exenatide in people with Morbid Obesity, run by Advanced Specialty Care at 2 sites in United States.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan E Boone, BS (541-322-1772, megan@advancedspecialtycare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2009.