Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Overweight, Obesity

In brief

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 by a separate subcutaneous (SC) injection in obese and overweight subjects.

Key facts

Study ID: NCT00673387
Run by: AstraZeneca
People needed: 636
Starts: 2008-04-01
Expected to finish: 2009-10-01
Last updated by the study team: 2015-04-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Research Site — Birmingham, Alabama, United States
Research Site — Chandler, Arizona, United States
Research Site — Santa Rosa, California, United States
Research Site — Walnut Creek, California, United States
Research Site — Denver, Colorado, United States
Research Site — Jacksonville, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Pembrook Pines, Florida, United States
Research Site — Plantation, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Springfield, Illinois, United States
Research Site — Overland Park, Kansas, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Auburn, Maine, United States
Research Site — Boston, Massachusetts, United States
Research Site — Edina, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — Butte, Montana, United States
Research Site — New York, New York, United States
Research Site — Statesville, North Carolina, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Columbus, Ohio, United States
Research Site — Eugene, Oregon, United States
Research Site — Medford, Oregon, United States

Full record on ClinicalTrials.gov

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