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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Final enrollment: 111 participants (planned 150) · Primary completion moved earlier from Nov 1, 2027 to May 7, 2027 · Eligibility criteria expanded, about 67 words · 2 more Show 5 more changesShow less
    • Final enrollment: 111 participants (planned 150)
    • Primary completion moved earlier from Nov 1, 2027 to May 7, 2027
    • Eligibility criteria expanded, about 67 words
    • Secondary endpoints: details revised at 4 of 24 entries
    • Site details revised at 7 of 7 sites
  2. Phase: Phase 1 to Phase 1/2 Primary completion date: May 4, 2026 to Nov 1, 2027 · Primary endpoint revised · Enrollment target: 120 to 150 · 8 morev14 Show 11 more changesShow less
    • Primary completion date: May 4, 2026 to Nov 1, 2027
    • Primary endpoint revised
    • Enrollment target: 120 to 150
    • Completion date: May 4, 2026 to Nov 1, 2028
    • Interventions: Part A: RM-718 or placebo (matched to specific RM-718 dose cohort) (Drug), Part B: RM-718 or placebo (matched to specific RM-718 dose… to Part A: RM-718 or placebo (matched to specific RM-718 dose cohort) (Drug), Part B: RM-718 or placebo (matched to specific RM-718 dose…
    • Eligibility criteria expanded, about 154 words
    • Secondary endpoints: 17 to 24
    • Study description expanded, about 30 words
    • Study sites revised (7)
    • Study arms: 13 to 17
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv13
  4. Site details revised at 2 of 7 sitesv12
  5. Site details revised at 1 of 7 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 1 of 7 sitesv10
  2. Site details revised at 1 of 7 sitesv9
  3. Site details revised at 1 of 7 sitesv8
  4. Primary and study completion dates: Jul 30, 2026 to May 4, 2026v7
  5. Primary and study completion dates: Jun 30, 2025 to Jul 30, 2026 Study sites: 1 to 7 · Secondary endpoints: 12 to 17 · Study description revised · 1 morev6 Show 4 more changesShow less
    • Study sites: 1 to 7
    • Secondary endpoints: 12 to 17
    • Study description revised
    • Study arms: 14 to 13

    See this version in full on ClinicalTrials.gov ↗

  6. Enrollment target: 90 to 120v5
  7. Start date changed from estimate of Feb 28, 2024 to Mar 5, 2024v4
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  9. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06239116
Lead Sponsor Rhythm Pharmaceuticals, Inc.
Conditions Hypothalamic Obesity, Prader-Willi Syndrome, PWS
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov