Conditions: Overweight Obesity
Keywords: overweight obesity pramlintide leptin Amylin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 177
Healthy volunteers: no

Brief summary:
This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.

Detailed description:

Arms:
arm 1: Placebo-pramlintide 600 microliters (µL) twice a day (BID) and metreleptin (recombinant-methionyl human leptin) 5 milligram (mg) BID, 20 weeks arm 2: Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and placebo-metreleptin 1 mL BID, 20 weeks arm 3: Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and metreleptin (recombinant-methionyl human leptin) 5 mg BID, 20 weeks arm 4: During the Lead-In Period before a participant was randomized to a study arm, the participant received 180 mcg pramlintide acetate twice a day (BID) for 2 weeks, followed by 360 mcg pramlintide acetate BID for 2 weeks (total of 4 weeks in the Lead-In Period).

Interventions: intervention 1: pramlintide acetate 360 mcg intervention 2: metreleptin intervention 3: placebo-pramlintide 600 uL intervention 4: placebo-metreleptin 1 mL intervention 5: Pramlintide acetate 180 mcg
Intervention descriptions: intervention 1: subcutaneous injection, twice a day, 360mcg intervention 2: subcutaneous injection, twice a day, 5mg intervention 3: twice a day intervention 4: twice a day intervention 5: subcutaneous injection twice a day, 180 mcg

Protocol document: