Weight GainPhase 4NCT00845507
Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults
A Phase 4 study testing Exenatide in people with Weight Gain, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder Exenatide has been approved by the FDA for the… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Weight Gain
- 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
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jul 2015
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be between the ages of 18 and 55 years old.
- Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR criteria and diagnosed using the Structured Clinical Interview for DSM-IV (SCID).
- Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and baseline visits.
- Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales.
- Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report.
- Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2.
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- Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable method(s) of contraception (e.g., hormonal methods, intrauterine device, abstinence) for at least one month prior to study entry and throughout the study.
- Subjects must be on a stable dose of olanzapine for at least 14 days and must have been on 5-30mg/day for at least 1 month.
- Major Exclusion Criteria
- Subjects with clinically significant suicidal or homicidal ideation.
- Subjects who have a DSM-IV lifetime diagnosis of a substance dependence disorder within the past 6 months or within the past month have been diagnosed with a substance abuse disorder, (except for nicotine abuse or dependence), as determined by psychiatric history or SCID interview.
- Subjects with a clinically significant or unstable medical disease, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions, that could interfere with diagnosis, assessment, or treatment of bipolar disorder or obesity, as well as subjects with a history of pancreatitis.
- Patients with clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices or clinically abnormal ECG.
- Female patients who are either pregnant or lactating.
- Any female patient whose sexual activity is unknown or in questions.
- Any history of current or past diabetes that has been treated with pharmacological intervention. Subjects who have a diagnosis of diabetes, are currently receiving exenatide, insulin, or an oral anti-hyperglycemic medication, or who have a nonfasting blood glucose ≥ 200 mg/dl or a fasting blood glucose ≥126 mg/dl on 2 separate tests. Subjects with pre-diabetes will not be excluded.
- Neurological disorders including epilepsy, stroke, or severe head trauma. Mental retardation (IQ <70).
- 10. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
- 11. Treatment with concurrent mood stabilizers (except lithium), anticonvulsants, or antipsychotics.
- 12. Other psychotic disorders (including delusional disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
- 13. Dysthymic disorder or depressive disorder not otherwise specified, bipolar disorder not otherwise specified.
- 14. Subjects previously enrolled in this study or have previously been treated with exenatide.
- 15. Subjects who have received an experimental drug within 30 days. 16. Subjects who are displaying current clinically significant depressive or manic symptoms, defined as a MADRS score >24 or a YMRS score > 16 or who currently meet DSM-IV-TR criteria for a manic, mixed, hypomanic, or depressive episode.
- 17. Subjects who are displaying current clinically significant psychotic symptoms, defined as any SAPS subscale score > 2 18. Subjects with a history of pancreatitis in themselves or any risk factors for developing pancreatitis (risk factors include but are not limited to: alcohol use, history of gallbladder disease or gallstones, diabetes or a family history of pancreatitis) 19. Subjects with elevated amylase or lipase levels as measured at the screening visit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Placebo-Controlled Study of Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults With Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder
The purpose of this research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder
Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.
It has not been approved for the treatment of weight gain associated with olanzapine in obese adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder
Read the detailed description
Double-blind studies suggest that olanzapine is highly effective for the treatment of individuals with bipolar disorder. However, weight gain and impaired glucose tolerance remain significant concerns associated with olanzapine. Exenatide is an anti-diabetic medication that is associated with weight loss and improved glucose regulation. Therefore, the overall goal of the proposed study is to conduct a 16-week double-blind placebo-controlled study of exenatide for the treatment of weight gain associated with olanzapine in 60 obese adults with bipolar disorder treated with olanzapine. We propose to conduct the study over the course of 24 months, with an expected enrollment of approximately 3 patients per month. The primary outcome measure will be change from baseline to endpoint in weight. The secondary outcome measures will include changes from baseline to endpoint, in body mass index (BMI), abdominal circumference, metabolic parameters, clinical global improvement of psychiatric symptoms, and change in manic, depressive and psychotic symptoms. Rates of adverse events also will be assessed.
- Conditions
- Weight Gain
- Being tested
- Exenatide, Placebo
- Keywords
- weight gain
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Exenatide (Byeta)
The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily.
PlaceboDrug
Placebo: Sterile solution in equivalent doses as Exenatide
| Study group | Role | What they receive |
|---|---|---|
| Exenatide Group | Experimental | Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg. Receives: Drug: Exenatide |
| Placebo Group | Placebo comparator | Placebo: Sterile solution in equivalent doses as Exenatide Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight From Baseline to Endpoint.
Change in weight from baseline to endpoint in the intent-to-treat (ITT) population (all subjects who took at least one dose of study medication and had one post-baseline evaluation).
Measured: 16 Weeks
Secondary outcomes (1)
Change in Body Mass Index (BMI) From Baseline to Endpoint.
Secondary outcome measures included change in body mass index (BMI).
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2015
- Study completionJul 2015
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 Weight GainStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Melissa Delbello, University of Cincinnati
- Investigators
- Melissa DelBello, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845507
- Sponsor's protocol ID
- Exenatide
- Status last verified
- Aug 2015
- First submitted
- 16 Feb 2009
- Last updated
- 20 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Patino LR, Strawn JR, Adler CM, Blom TJ, Welge JA, DelBello MP. A double-blind, placebo-controlled trial of exenatide for the treatment of olanzapine-related weight gain in obese and overweight adults. J Affect Disord. 2025 Aug 1;382:116-122. doi: 10.1016/j.jad.2025.04.046. Epub 2025 Apr 7.
PubMed 40203970
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Study of Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults With Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00845507
- Acronym / sponsor ID
- Exenatide
- Conditions
- Weight Gain
- Keywords
- weight gain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 20 Apr 2018
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 research study is to test the safety and efficacy (how well it works) of exenatide as a treatment for weight gain associated with olanzapine in obese adults with Bipolar Disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder
Exenatide has been approved by the FDA for the treatment of Type 2 diabetes.
It has not been approved for the treatment of weight gain associated with olanzapine in obese adults with bipolar disorder, Major Depressive Disorder, Schizophrenia or Schizoaffective Disorder
Detailed description
Double-blind studies suggest that olanzapine is highly effective for the treatment of individuals with bipolar disorder. However, weight gain and impaired glucose tolerance remain significant concerns associated with olanzapine. Exenatide is an anti-diabetic medication that is associated with weight loss and improved glucose regulation. Therefore, the overall goal of the proposed study is to conduct a 16-week double-blind placebo-controlled study of exenatide for the treatment of weight gain associated with olanzapine in 60 obese adults with bipolar disorder treated with olanzapine. We propose to conduct the study over the course of 24 months, with an expected enrollment of approximately 3 patients per month. The primary outcome measure will be change from baseline to endpoint in weight. The secondary outcome measures will include changes from baseline to endpoint, in body mass index (BMI), abdominal circumference, metabolic parameters, clinical global improvement of psychiatric symptoms, and change in manic, depressive and psychotic symptoms. Rates of adverse events also will be assessed.
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 Group | Experimental | Drug: ExenatideExenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg. |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo: Sterile solution in equivalent doses as Exenatide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Subjects must be between the ages of 18 and 55 years old.
- Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR criteria and diagnosed using the Structured Clinical Interview for DSM-IV (SCID).
- Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and baseline visits.
- Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales.
- Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report.
Key exclusion criteria (0 listed)
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: Exenatide (Byeta)The dosage of study medication will be 5 mcg injection of exenatide twice daily for 28 days. On day 28 the dosage may be increased, as tolerated, to 10 mcg twice daily. | Drug | Exenatide Group |
| PlaceboPlacebo: Sterile solution in equivalent doses as Exenatide | Drug | Placebo Group |
Primary outcome
Change in Weight From Baseline to Endpoint.
Time frame: 16 Weeks
Change in weight from baseline to endpoint in the intent-to-treat (ITT) population (all subjects who took at least one dose of study medication and had one post-baseline evaluation).
1 secondary outcome
Change in Body Mass Index (BMI) From Baseline to Endpoint.
Time frame: 16 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40203970Patino LR, Strawn JR, Adler CM, Blom TJ, Welge JA, DelBello MP. A double-blind, placebo-controlled trial of exenatide for the treatment of olanzapine-related weight gain in obese and overweight adults. J Affect Disord. 2025 Aug 1;382:116-122. doi: 10.1016/j.jad.2025.04.046. Epub 2025 Apr 7.
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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.
Melissa DelBello, MD principal investigator
University of Cincinnati
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 in people with Weight Gain, run by University of Cincinnati 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 25 inclusion and 0 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 20 Apr 2018. 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 20 Apr 2018). 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 Weight From Baseline to Endpoint. (time frame: 16 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 NCT00845507, 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 20 Apr 2018.