Status:
COMPLETED
A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.
Eligibility Criteria
Inclusion
- Is obese (Body Mass Index \[BMI\]\>=30kg/m\^2 and \<=35kg/m\^2); or overweight (BMI\>=27kg/m\^2 and \<30kg/m\^2) with abdominal obesity, based on the following: \*waist circumference \>102 cm if male, \*waist circumference \>88 cm if female
- Is a nonsmoker (has not smoked for at least 6 months prior to the study)
- Consumes a morning and evening meal each day
Exclusion
- Is diagnosed with type 2 diabetes
- Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion)
- Has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with any of the following medications: \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility
- Has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting
- Has previously received treatment with recombinant leptin or pramlintide
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00392925
Start Date
October 1 2006
End Date
September 1 2007
Last Update
April 14 2015
Active Locations (12)
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1
Research Site
DeLand, Florida, United States
2
Research Site
Chicago, Illinois, United States
3
Research Site
Indianapolis, Indiana, United States
4
Research Site
Overland Park, Kansas, United States