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A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 8 to 11 Primary completion date: Sep 30, 2026 to Mar 13, 2027 · Completion date: Sep 30, 2027 to Mar 13, 2028v8 Show 2 more changesShow less
    • Primary completion date: Sep 30, 2026 to Mar 13, 2027
    • Completion date: Sep 30, 2027 to Mar 13, 2028
  2. Study sites: 5 to 8v7
  3. Primary completion date: Jan 30, 2027 to Sep 30, 2026 Completion date: Jan 30, 2027 to Sep 30, 2027v6 Show 1 more changeShow less
    • Completion date: Jan 30, 2027 to Sep 30, 2027
  4. Study sites: 4 to 5 Start date changed from estimate of Sep 22, 2025 to Sep 23, 2025v5 Show 1 more changeShow less
    • Start date changed from estimate of Sep 22, 2025 to Sep 23, 2025
  5. Trial status: Not Yet Recruiting to Recruiting Start date: Jun 20, 2025 to Sep 22, 2025 · Study sites: 0 to 4v4 Show 2 more changesShow less
    • Start date: Jun 20, 2025 to Sep 22, 2025
    • Study sites: 0 to 4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Apr 30, 2025 to Jun 20, 2025v3
  2. Start date: Mar 30, 2025 to Apr 30, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.
Trial Details
NCT Number NCT06760546
Lead Sponsor Rhythm Pharmaceuticals, Inc.
Conditions Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia, Childhood-onset Combined Pituitary Hormone Deficiency, Pituitary Stalk Interruption Syndrome
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov