A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorRhythm Pharmaceuticals, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator.
Active or history of any significant medical condition such as and including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.
Obesity due to genetic, syndromic, or endocrine etiologies.
History of renal transplant, end stage renal disease.
Trial design
Treatments tested in this trial
- Part A: RM-718 or placebo (matched to specific RM-718 dose cohort)
- Part B: RM-718 or placebo (matched to specific RM-718 dose cohort)
- Part C: RM-718
- Part D: RM-718
Treatment groups
150 Participants
are divided into 17 treatment groups17
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov