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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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 Group

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.


Participant Flow:   Overall Study
    Exenatide Group   Placebo Group
STARTED   24   30 
COMPLETED   22   29 
NOT COMPLETED   2   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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 Group

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 Total of all reporting groups

Baseline Measures
   Exenatide Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   30   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.2  (9.3)   39.3  (11.7)   41.4  (10.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  62.5%      21  70.0%      36  66.7% 
Male      9  37.5%      9  30.0%      18  33.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
White      12  50.0%      18  60.0%      30  55.6% 
Non-White      12  50.0%      12  40.0%      24  44.4% 
Region of Enrollment 
[Units: Participants]
     
United States   24   30   54 
Weight 
[Units: Pounds]
Mean (Standard Deviation)
 197  (32)   209  (51)   204  (44) 


  Outcome Measures

1.  Primary:   Change in Weight From Baseline to Endpoint.   [ Time Frame: 16 Weeks ]

2.  Secondary:   Change in Body Mass Index (BMI) From Baseline to Endpoint.   [ Time Frame: 16 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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:  
Name/Title: Dr. DelBello
Organization: University of Cincinnati
phone: 513-558-2989
e-mail: Melissa.Delbello@uc.edu



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