ObesityPhase 4NCT01590433
Weight Loss With Exenatide Treatment
A Phase 4 study testing Exenatide and Dietary counseling in people with Obesity, run by Jody Dushay at 1 site in United States.
Trial summary
The investigators are conducting a study that will investigate the possible mechanisms of weight loss associated with exenatide treatment and the metabolic characteristics of high responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exenatide and Dietary counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jan 2019
- Phase
- Phase 4
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females age 18-70
- BMI 28-48 kg/m^2
- Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).
- Ability to give informed consent and follow verbal and written instructions in English.
Who cannot join
- Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- Unstable heart disease as evidenced by ongoing angina
- Congestive heart failure
- Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)
- Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)
- Tobacco, marijuana, cocaine, or intravenous drug use
Show all 23Show fewer
- Shift workers (night shift or alternating day/night shifts)
- Gastroparesis
- Inflammatory bowel disease or irritable bowel syndrome
- Malignancy treated with chemotherapy within the past 3 years
- History of pancreatitis
- Depression requiring hospitalization or diagnosis of psychosis
- Renal insufficiency (eGFR less than 50)
- Transaminases greater than 2 times above the normal range
- Pregnancy within 6 months of the screening visit
- Lactation
- Failure to use medically approved contraceptive methods (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
- History of an eating disorder (anorexia, bulimia or laxative abuse)
- Treatment with FDA-approved or over-the-counter weight loss medication within 6 months, with the exception of Xenical if there was no weight loss
- History of gastric bypass surgery or gastric stapling
- Biochemical evidence of hyper or hypothyroidism, or new diagnosis of hypo or hyperthyroidism within 3 months of screening visit
- Previous treatment with exenatide
- Discretion of the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes
The investigators are conducting a study that will investigate the possible mechanisms of weight loss associated with exenatide treatment and the metabolic characteristics of high responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment. The investigators will also examine the magnitude and duration of weight loss among a cohort of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment.
Hypothesis:
The mechanisms of weight loss with exenatide are not fully understood, and weight loss responses to exenatide are highly variable, possibly reflecting distinct metabolic parameters. By identifying and following a group of obese women who lose greater than 5% body weight after short-term exenatide treatment, the investigators can gain insights into the possible mechanisms of weight loss and assess long-term weight loss with this pharmacotherapeutic intervention.
Read the detailed description
Primary Outcomes
The primary objectives of this study is:
- To investigate possible mechanisms and patterns of weight loss with exenatide treatment, especially among individuals who have robust early weight loss (greater than 5% weight loss in 12 weeks) with exenatide.
Secondary Outcomes
Our secondary objective is to identify metabolic characteristics that predict robust response to exenatide treatment.
Outcome measurements:
- Weight
- Body composition
- Resting energy expenditure (REE)
- Mixed meal test
- Thermic effect of food
- Serum metabolic parameters
- Hunger/Nausea/Satiety visual analog scales (VAS)
- Physical activity monitoring
Study Population
The study population will be generally healthy, non-diabetic women age 18-70 years with BMI 28-48 kg/m^2.
- Conditions
- Obesity
- Being tested
- Exenatide, Placebo, Dietary counseling
- Keywords
- Obesity, Overweight, Exenatide, Diet, Women
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Subjects will inject 5mcg of exenatide subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
PlaceboDrug
Subjects will inject 5mcg of identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
Dietary counselingBehavioural
All subjects will also receive individualized dietary counseling. Subjects in the placebo group will be counseled to follow a hypocaloric diet.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive exenatide will not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of study team will know which they are receiving. Receives: Drug: Exenatide |
| Placebo | Placebo comparator | Subjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive placebo will be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of the study team will know which they are receiving. Receives: Drug: Placebo; Behavioral: Dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jody Dushay
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Jody Dushay, Beth Israel Deaconess Medical Center
- Investigators
- Eleftheria Maratos-Flier, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590433
- Sponsor's protocol ID
- 2011P000310
- Status last verified
- Jun 2021
- First submitted
- 24 Feb 2012
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodgers M, Migdal AL, Rodriguez TG, Chen ZZ, Nath AK, Gerszten RE, Kasid N, Toschi E, Tripaldi J, Heineman B, Phan M, Ngo L, Maratos-Flier E, Dushay J. Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women. Front Endocrinol (Lausanne). 2021 Nov 17;12:742873. doi: 10.3389/fendo.2021.742873. eCollection 2021.
PubMed 34867786
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes
- ClinicalTrials.gov ID
- NCT01590433
- Acronym / sponsor ID
- 2011P000310
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Exenatide, Diet, Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Jody DushayUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2012
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting a study that will investigate the possible mechanisms of weight loss associated with exenatide treatment and the metabolic characteristics of high responders (i.e. subjects who achieve greater than 5% weight loss) to exenatide treatment. The investigators will also examine the magnitude and duration of weight loss among a cohort of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment.
Hypothesis:
The mechanisms of weight loss with exenatide are not fully understood, and weight loss responses to exenatide are highly variable, possibly reflecting distinct metabolic parameters. By identifying and following a group of obese women who lose greater than 5% body weight after short-term exenatide treatment, the investigators can gain insights into the possible mechanisms of weight loss and assess long-term weight loss with this pharmacotherapeutic intervention.
Detailed description
Primary Outcomes
The primary objectives of this study is:
- To investigate possible mechanisms and patterns of weight loss with exenatide treatment, especially among individuals who have robust early weight loss (greater than 5% weight loss in 12 weeks) with exenatide.
Secondary Outcomes
Our secondary objective is to identify metabolic characteristics that predict robust response to exenatide treatment.
Outcome measurements:
- Weight
- Body composition
- Resting energy expenditure (REE)
- Mixed meal test
- Thermic effect of food
- Serum metabolic parameters
- Hunger/Nausea/Satiety visual analog scales (VAS)
- Physical activity monitoring
Study Population
The study population will be generally healthy, non-diabetic women age 18-70 years with BMI 28-48 kg/m^2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: ExenatideSubjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive exenatide will not be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of study team will know which they are receiving. |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Dietary counselingSubjects will be randomly assigned to the exenatide study treatment group or to the placebo study treatment group. Subjects will have a 33 percent chance of being assigned to the placebo study treatment group and a 66 percent chance of being assigned to exenatide study treatment. Subjects will not be able to choose the study group to which they will be assigned. All study participants will receive individualized dietary counseling based on food logs. Subjects who receive placebo will be assigned to follow a reduced-calorie diet in addition to study treatment. Subjects will not know whether they are receiving exenatide or placebo, but the unblinded members of the study team will know which they are receiving. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females age 18-70
- BMI 28-48 kg/m^2
- Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).
- Ability to give informed consent and follow verbal and written instructions in English.
Key exclusion criteria (23 listed)
- Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- Unstable heart disease as evidenced by ongoing angina
- Congestive heart failure
- Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)
- Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)
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 |
|---|---|---|
| ExenatideSubjects will inject 5mcg of exenatide subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study. | Drug | Exenatide |
| PlaceboSubjects will inject 5mcg of identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study. | Drug | Placebo |
| Dietary counselingAll subjects will also receive individualized dietary counseling. Subjects in the placebo group will be counseled to follow a hypocaloric diet. | Behavioural | Placebo |
Primary outcome
Change in Body Weight
Time frame: 12 weeks
Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34867786Rodgers M, Migdal AL, Rodriguez TG, Chen ZZ, Nath AK, Gerszten RE, Kasid N, Toschi E, Tripaldi J, Heineman B, Phan M, Ngo L, Maratos-Flier E, Dushay J. Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women. Front Endocrinol (Lausanne). 2021 Nov 17;12:742873. doi: 10.3389/fendo.2021.742873. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Eleftheria Maratos-Flier, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide and Dietary counseling in people with Obesity, run by Jody Dushay at 1 site 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 23 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 12 Feb 2020). 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: 12 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 NCT01590433, 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 23 Jun 2021; AzTrials last refreshed its copy on 31 Oct 2026.