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

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ClinicalTrials.gov Identifier: NCT00845507
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Weight Gain
Interventions Drug: Exenatide
Drug: Placebo
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exenatide Group Placebo Group
Hide Arm/Group Description

Exenatide 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.

Placebo: 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.

Period Title: Overall Study
Started 24 30
Completed 22 29
Not Completed 2 1
Arm/Group Title Exenatide Group Placebo Group Total
Hide Arm/Group Description

Exenatide 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.

Placebo: 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.

Total of all reporting groups
Overall Number of Baseline Participants 24 30 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 30 participants 54 participants
44.2  (9.3) 39.3  (11.7) 41.4  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 30 participants 54 participants
Female
15
  62.5%
21
  70.0%
36
  66.7%
Male
9
  37.5%
9
  30.0%
18
  33.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 24 participants 30 participants 54 participants
White
12
  50.0%
18
  60.0%
30
  55.6%
Non-White
12
  50.0%
12
  40.0%
24
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 30 participants 54 participants
24 30 54
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 24 participants 30 participants 54 participants
197  (32) 209  (51) 204  (44)
1.Primary Outcome
Title Change in Weight From Baseline to Endpoint.
Hide 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).
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication and had one post-baseline evaluation.
Arm/Group Title Exenatide Group Placebo Group
Hide Arm/Group Description:

Exenatide 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.

Placebo: 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.

Overall Number of Participants Analyzed 22 29
Mean (Standard Deviation)
Unit of Measure: Pounds
-1.1  (6.2) 5.9  (10.3)
2.Secondary Outcome
Title Change in Body Mass Index (BMI) From Baseline to Endpoint.
Hide Description Secondary outcome measures included change in body mass index (BMI).
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication and had one post-baseline evaluation.
Arm/Group Title Exenatide Group Placebo Group
Hide Arm/Group Description:

Exenatide 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.

Placebo: 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.

Overall Number of Participants Analyzed 22 29
Mean (Standard Deviation)
Unit of Measure: Kgs/meter squared
-0.2  (1.0) 1.0  (1.7)
Time Frame Up to 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Group Placebo Group
Hide Arm/Group Description

Exenatide 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.

Placebo: 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.

All-Cause Mortality
Exenatide Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/24 (8.33%)      1/30 (3.33%)    
Gastrointestinal disorders     
Hospitalization for Mallory-Weiss tear *  1/24 (4.17%)  1 0/30 (0.00%)  0
Psychiatric disorders     
Hospitalization for exacerbation of depressive symptoms *  1/24 (4.17%)  1 1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exenatide Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/24 (58.33%)      11/30 (36.67%)    
Gastrointestinal disorders     
Gastointestinal disturbance (includes acid reflux, constipation, diarrhea, heartburn, nausea etc) *  14/24 (58.33%)  14 11/30 (36.67%)  11
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. DelBello
Organization: University of Cincinnati
Phone: 513-558-2989
EMail: Melissa.Delbello@uc.edu
Layout table for additonal information
Responsible Party: Melissa Delbello, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00845507     History of Changes
Other Study ID Numbers: Exenatide
First Submitted: February 16, 2009
First Posted: February 18, 2009
Results First Submitted: November 20, 2017
Results First Posted: April 20, 2018
Last Update Posted: April 20, 2018