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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 4
Enrollment
54 participants (actual)
Sponsor
University of Cincinnati · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Dec 2008
Primary completion
Jul 2015
Completion
Jul 2015
First posted
18 Feb 2009 (estimated)
Last update posted
20 Apr 2018
Conditions
Weight Gain

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. Ph 4

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

    NCT00845507

    Dec 2008 to Jul 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ExenatideDrug
  • PlaceboDrug

Arms2

  • 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.

  • Placebo comparator

    Placebo Group

    Placebo: Sterile solution in equivalent doses as Exenatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Weight From Baseline to Endpoint.

    Time frame · 16 Weeks

    Registry description

    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).

Secondary outcomes(1)
  1. Change in Body Mass Index (BMI) From Baseline to Endpoint.

    Time frame · 16 Weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 16 Weeks

Change in Weight From Baseline to Endpoint.

GroupValue (Pounds)Spread
Exenatide Group-1.16.2
Placebo Group5.910.3
Secondary and other outcome results(1)
Secondary outcomeMean· 16 Weeks

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

GroupValue (Kgs/meter squared)Spread
Exenatide Group-0.21.0
Placebo Group1.01.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide GroupExenatide dstarted at 5 mcg subcutaneously twice daily within one hour before the morning and evening meals, and increased (as tolerated) to 10 mcg. Exenatide: 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.–2 / 2414 / 24
Placebo GroupPlacebo: Sterile solution in equivalent doses as Exenatide Exenatide: 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.–1 / 3011 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

5 results

A double-blind, placebo-controlled trial of exenatide for the treatment of olanzapine-related weight gain in obese and overweight adults.

Patino et al. 2025Journal of affective disorderscited by 8

PMID 40203970DOI 10.1016/j.jad.2025.04.046PUB-40203970

Full text at the publisher5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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). 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

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