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CompletedNCT00845507Updated Apr 20, 2018Results posted

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

A Phase 4 interventional study of Exenatide and Placebo in Weight Gain, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by University of Cincinnati · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Weight Gain

Keywords

  • weight gain
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 54 is below the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion 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).
  1. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
  1. Treatment with concurrent mood stabilizers (except lithium), anticonvulsants, or antipsychotics.
  1. 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.
  1. Dysthymic disorder or depressive disorder not otherwise specified, bipolar disorder not otherwise specified.
  1. Subjects previously enrolled in this study or have previously been treated with exenatide.
  1. 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.
  1. 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Exenatide Group

    Exenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg.

    Drug: Exenatide

  • Placebo comparator
    Placebo Group

    Placebo: Sterile solution in equivalent doses as Exenatide

    Drug: Placebo

Interventions

  • DrugExenatide

    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.

    Also known as: Exenatide (Byeta)

  • DrugPlacebo

    Placebo: Sterile solution in equivalent doses as Exenatide

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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).

    Time frame: 16 Weeks

07

Results

Posted Apr 20, 2018

Participant flow

Participant flow — Overall Study
MilestoneExenatide GroupPlacebo Group
Started2430
Completed2229
Not completed21

Outcome measures

PrimaryChange 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).

Time frame:
16 Weeks
Reported as:
Mean · Pounds
Change in Weight From Baseline to Endpoint.
PoundsExenatide GroupPlacebo Group
Change in Weight From Baseline to Endpoint.-1.1 ± 6.25.9 ± 10.3
SecondaryChange in Body Mass Index (BMI) From Baseline to Endpoint.

Secondary outcome measures included change in body mass index (BMI).

Time frame:
16 Weeks
Reported as:
Mean · Kgs/meter squared
Change in Body Mass Index (BMI) From Baseline to Endpoint.
Kgs/meter squaredExenatide GroupPlacebo Group
Change in Body Mass Index (BMI) From Baseline to Endpoint.-0.2 ± 1.01.0 ± 1.7

Adverse events

Collected over Up to 16 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Exenatide Group—2/24 (8.3%)14/24 (58.3%)
Placebo Group—1/30 (3.3%)11/30 (36.7%)
Most frequent serious events
Most frequent serious events
EventExenatide GroupPlacebo Group
Hospitalization for exacerbation of depressive symptomsPsychiatric disorders1/241/30
Hospitalization for Mallory-Weiss tearGastrointestinal disorders1/240/30
Most frequent other events
Most frequent other events
EventExenatide GroupPlacebo Group
Gastointestinal disturbance (includes acid reflux, constipation, diarrhea, heartburn, nausea etc)Gastrointestinal disorders14/2411/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)Exenatide GroupPlacebo GroupTotal
Mean44.2 ± 9.339.3 ± 11.741.4 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Exenatide GroupPlacebo GroupTotal
Female152136
Male9918
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Exenatide GroupPlacebo GroupTotal
Race — White121830
Race — Non-White121224
Region of Enrollment
Region of Enrollment(participants)Exenatide GroupPlacebo GroupTotal
United States243054
Weight
Weight(Pounds)Exenatide GroupPlacebo GroupTotal
Mean197 ± 32209 ± 51204 ± 44
08

Study locations

1 site
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00845507
Lead sponsor
University of Cincinnati
Collaborators
Eli Lilly and Company
Responsible party
Melissa Delbello (Professor, University of Cincinnati) — Principal investigator
First posted
Feb 18, 2009
Start date
Dec 2008
Primary completion
Jul 2015
Completion
Jul 2015
Results posted
Apr 20, 2018
Last update
Apr 20, 2018

Study contacts

Melissa DelBello, MD
principal investigator · University of Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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