Status:
COMPLETED
Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered b...
Eligibility Criteria
Inclusion
- 18 to 65 years old.
- Is obese (Body Mass Index \[BMI\]\>=30kg/m\^2 and \<=35kg/m\^2); or overweight (BMI\>=27kg/m\^2 and \<30kg/m\^2.
- Has stable body weight, i.e., not varying by \>3% within 3 months prior to study.
- Has not been treated over the past 3 months or is currently treated with any of the following medications: Oral contraceptives (female subjects); Hormone replacement therapy (female subjects); Metformin for the treatment of polycystic ovary syndrome (female subjects); Antihypertensive agents; Lipid-lowering agents; Thyroid replacement therapy; selective serotonin reuptake inhibitors (SSRIs).
- Is comfortable with having repeated telephone contacts with a lifestyle counselor during the study.
- Is a nonsmoker (has not smoked for at least 6 months prior to the study).
Exclusion
- Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics suggestive of genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet-Biedl syndrome).
- 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 \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility, \*antidiabetic medications.
- Has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®).
- 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 had a major surgery or a blood transfusion, or has donated blood over the past 2 months or is planning to donate blood during the study.
- Has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure during the study.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
636 Patients enrolled
Trial Details
Trial ID
NCT00673387
Start Date
April 1 2008
End Date
October 1 2009
Last Update
April 15 2015
Active Locations (36)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Chandler, Arizona, United States
3
Research Site
Santa Rosa, California, United States
4
Research Site
Walnut Creek, California, United States