Conditions: Overweight and Obesity
Keywords: Overweight
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide administered once or twice daily. The study drug (setmelanotide and placebo) will be administered in a blinded fashion.

Detailed description:

Arms:
arm 1: Once daily in the morning, equivalent placebo in evening. arm 2: Split dose, one half in the morning and one half in the evening. arm 3: Placebo in the morning, placebo in the evening.

Interventions: intervention 1: Setmelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: