Study of Weekly RM-718 in Adults with Obesity and Patients Aged 12-65 with Hypothalamic Obesity or Prader-Willi Syndrome

What this Trial Is About

Researchers are studying RM-718 to assess its safety, tolerability, and how the body processes it in healthy individuals with obesity and in patients with impairments in the MC4R pathway. This study includes people aged 12 to 65 years and focuses on those with hypothalamic obesity and Prader-Willi Syndrome, conditions related to obesity caused by specific brain or genetic issues. The study has four parts Part A tests single weekly doses of RM-718 or placebo in healthy obese adults aged 18 to 55 Part B tests multiple weekly doses in a similar group Part C involves multiple weekly doses in patients aged 12 to 65 with hypothalamic obesity and Part D gives multiple weekly doses to patients with Prader-Willi Syndrome aged 12 to 65. Doses are administered by weekly injections under the skin, and parts A and B are randomized, placebo-controlled, and double-blind, while parts C and D are open-label dose escalations. Participants will receive various weekly doses of RM-718 or placebo depending on their study part, with monitoring for side effects throughout. Researchers will assess safety by tracking adverse events during and after treatment, as well as measure how the drug behaves in the body over time. They will also monitor changes in body mass index, weight, waist size, and hunger symptoms in patients with hypothalamic obesity and Prader-Willi Syndrome. The study includes safety follow-up calls extending up to 210 days after dosing in some parts, with total participation lasting up to 26 weeks depending on the group.

A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment