A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.

Key facts

Study ID

NCT01235741

Run by

AstraZeneca

People needed

213

Starts

2011-01-01

Expected to finish

2011-09-01

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…

• Is obese with a BMI ≥35 to ≤45 kg/m2.
• Has stable body weight (not varying by >5% within 3 months prior to study start).
• Meets certain requirements with respect to concomitant medications.
• Has not smoked or used nicotine-containing products for at least 12 months prior to study start.

You may not qualify if…

• Has not been enrolled in a weight loss program within 2 months prior to study start.

Where it is running

• Research Site — Greenbrae, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Hyattsville, Maryland, United States
• Research Site — Boston, Massachusetts, 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 — Tulsa, Oklahoma, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Austin, Texas, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Arlington, Virginia, United States
• Research Site — Norfolk, Virginia, United States
• Research Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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