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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Rhythm Pharmaceuticals, Inc.
Study ID
NCT06239116
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hypothalamic Obesity
  • PWS
  • Prader-Willi Syndrome

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Part A: RM-718 or placebo (matched to specific RM-718 dose cohort) — DRUG
    Single ascending dose of RM-718 or placebo (matched to specific RM-718 Part A dose cohort)
  • Part B: RM-718 or placebo (matched to specific RM-718 dose cohort) — DRUG
    Multiple ascending doses of RM-718 or placebo (matched to specific RM-718 Part B dose cohorts)
  • Part C: RM-718 — DRUG
    Multiple ascending doses of RM-718
  • Part D: RM-718 — DRUG
    Multiple ascending doses of RM-718

Study Details

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

Key Dates

Start date
Mar 5, 2024
Status verified
Dec 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RM-718 (Cohort A1)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A2)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A3)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A4)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A5)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A6)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A7)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A8)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort A9)
    Single dose of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort B1)
    Multiple ascending doses of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort B2)
    Multiple ascending doses of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort B3)
    Multiple ascending doses of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort B4)
    Multiple ascending doses of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort B5)
    Multiple ascending doses of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort B6)
    Multiple ascending doses of RM-718 (4) or placebo (2)
  • Experimental: RM-718 (Cohort C1)
    Multiple ascending doses of RM-718 (30)
  • Experimental: RM-718 (Cohort D1)
    Multiple ascending doses of RM-718 (up to 30)

Primary Outcome Measure

Parts A, B, C, D: Safety and Tolerability Assessed by Number of Study Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From Day 1 through the Safety-Follow-up call (up to Day 43 for all Part A cohorts, up to Day 70 for all Part B cohorts, up to Day 140 for Part C cohort, up to Day 210 for Part D cohort) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UAB Pediatric Endocrinology (Part C and Part D)BirminghamAlabama35233-
Ann and Robert H. Lurie Children's Hospital of Chicago (Part C and Part D)ChicagoIllinois60611-
Boston Children's Hospital (Part C only)BostonMassachusetts021115-
Brigham and Women's Hospital (Part C and Part D)BostonMassachusetts02115-
Vanderbilt University Medical Center (Part C only)NashvilleTennessee37232-
Worldwide Clinical Trials (Part A and Part B)San AntonioTexas78217-
University of Utah Pediatric Endocrine Clinic (Part C and Part D)Salt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By research site
UAB Pediatric Endocrinology (Part C and Part D)· Birmingham, ALAnn and Robert H. Lurie Children's Hospital of Chicago (Part C and Part D)· Chicago, ILBoston Children's Hospital (Part C only)· Boston, MABrigham and Women's Hospital (Part C and Part D)· Boston, MAVanderbilt University Medical Center (Part C only)· Nashville, TNWorldwide Clinical Trials (Part A and Part B)· San Antonio, TX

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