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CompletedPhase 4Results posted

Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults

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

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

54

actual

Study population

Obesity / overweight, Psychiatric (schizophrenia / bipolar / depression)

Key I/E criterion

BMI ≥30

Primary endpoint

Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00845507
Org study IDExenatide

Timeline

Milestones

Study first posted2009-02-18estimated
Last update posted2018-04-20actual
Results first posted2018-04-20actual
Study start2008-12 (month precision)
Primary completion2015-07actual (month precision)
Study completion2015-07actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

1. Subjects must be between the ages of 18 and 55 years old.

2. 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).

3. 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.

4. Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales.

5. Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report.

6. Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2.

7. Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained.

8. 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.

9. 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

1. Subjects with clinically significant suicidal or homicidal ideation.

2. 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.

3. 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.

4. 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.

5. Female patients who are either pregnant or lactating.

6. Any female patient whose sexual activity is unknown or in questions.

7. 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.

8. 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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

2 endpoints
Primary/protocol endpoint

Change in Weight From Baseline to Endpoint.

Time frame:16 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Pounds95% CI
Exenatide Group-1.1
Placebo Group5.9
Secondary/protocol endpoint

Change in Body Mass Index (BMI) From Baseline to Endpoint.

Time frame:16 Weeks

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), Kgs/meter squared95% CI
Exenatide Group-0.2
Placebo Group1.0

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.