Rhythm Pharmaceuticals announced that the first patients have been dosed in the Company’s Phase 1 clinical trial of RM-718, an investigational, weekly melanocortin-4 receptor- specific agonist designed to be MC1R-sparing and to potentially avoid hyperpigmentation. This Phase 1 trial is a three-part study to evaluate safety, tolerability and pharmacokinetics. The study consists of Part A: single ascending doses of RM-718 in healthy participants 18 to 55 years old with obesity; Part B: multiple ascending doses of RM-718 in healthy participants 18 to 55 years old with obesity; and Part C: MAD of RM-718 in patients 12 to 65 years old with hypothalamic obesity. Cohorts in Parts A and B are double-blind, placebo-controlled, and randomized 2:1. Study participants will receive one weekly dose of either RM-718 or placebo in Part A, four weekly doses of either RM-718 or placebo in Part B, and four weekly doses of open-label RM-718 in Part C. RM-718 or placebo doses are administered weekly via subcutaneous injection. The anticipated enrollment for this study is 96 participants.
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