Conditions: Overweight Obesity
Keywords: overweight obesity pramlintide metreleptin Amylin
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 636
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Placebo matched to pramlintide BID plus placebo matched to metreleptin BID arm 2: 360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID arm 3: Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID arm 4: Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID arm 5: Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID arm 6: Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID arm 7: Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID arm 8: Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID

Interventions: intervention 1: pramlintide acetate intervention 2: metreleptin intervention 3: placebo-P intervention 4: placebo-M
Intervention descriptions: intervention 1: subcutaneous injection, twice a day intervention 2: subcutaneous injection, twice a day intervention 3: subcutaneous injection, twice a day intervention 4: subcutaneous injection, twice a day

Protocol document: