A Study of RM-718 Weekly Formulation in Healthy Subjects With Obesity and in Patients With Obesity Due to MC4R Impairment
Rhythm Pharmaceuticals, Inc.
Summary
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
Description
This is a first-in-human and first-in-patient, 4-part study that includes the evaluation of safety, tolerability, and PK of: single ascending doses (SAD) of RM-718 weekly (RM-718) in healthy subjects 18 to 55 years of age with obesity (Part A), multiple ascending doses (MAD) of RM-718 in healthy subjects 18 to 55 years of age with obesity (Part B), MAD of RM-718 in patients 12 to 65 years of age with HO (Part C), and MAD of RM-718 in patients with PWS (Part D). Cohorts in Parts A and B are double-blind, placebo-controlled, and randomized 2:1 (4 subjects receive RM-718, 2 subjects receive place…
Eligibility
- Age range
- 12–65 years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria: Parts A and B: * Male and female subjects in good health aged 18-55 years of age at Screening. * Body mass index (BMI) ≥30 kg/m2. * Subjects who are medically healthy with normal or clinically insignificant screening results. * Subjects must use a highly effective form of contraception and follow the study contraception requirements. * Ability to communicate well with the Investigator, understand and comply with the requirements of the trial, and understand English and sign the written informed consent. Part C: * Male and female patients with HO, aged 12-65 years of…
Interventions
- DrugPart A: RM-718 or placebo (matched to specific RM-718 dose cohort)
Single ascending dose of RM-718 or placebo (matched to specific RM-718 Part A dose cohort)
- DrugPart B: RM-718 or placebo (matched to specific RM-718 dose cohort)
Multiple ascending doses of RM-718 or placebo (matched to specific RM-718 Part B dose cohorts)
- DrugPart C: RM-718
Multiple ascending doses of RM-718
- DrugPart D: RM-718
Multiple ascending doses of RM-718
Locations (7)
- UAB Pediatric Endocrinology (Part C and Part D)Birmingham, Alabama
- Ann and Robert H. Lurie Children's Hospital of Chicago (Part C and Part D)Chicago, Illinois
- Boston Children's Hospital (Part C only)Boston, Massachusetts
- Brigham and Women's Hospital (Part C and Part D)Boston, Massachusetts
- Vanderbilt University Medical Center (Part C only)Nashville, Tennessee
- Worldwide Clinical Trials (Part A and Part B)San Antonio, Texas