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A Trial of Setmelanotide in Acquired Hypothalamic Obesity

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Publications: details revised at 1 of 2 entriesv36
  2. Results first posted: May 29, 2026 Secondary endpoints revised (16)v35 Show 1 more changeShow less
    • Secondary endpoints revised (16)

    See this version in full on ClinicalTrials.gov ↗

  3. Secondary endpoints revised (16)v34 See this version in full on ClinicalTrials.gov ↗
  4. Primary endpoint revised Enrollment target: estimated 120 to confirmed 143 · Secondary endpoints: 11 to 16v33 Show 2 more changesShow less
    • Enrollment target: estimated 120 to confirmed 143
    • Secondary endpoints: 11 to 16

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv32
Show 30 earlier versionsHide 30 earlier versions
  1. Primary completion date changed from estimate of Apr 16, 2025 to Mar 18, 2025 Completion date: Apr 16, 2025 to Apr 16, 2027v31 Show 1 more changeShow less
    • Completion date: Apr 16, 2025 to Apr 16, 2027
  2. Study sites: 24 to 28v30
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting Study sites: 25 to 24v29 Show 1 more changeShow less
    • Study sites: 25 to 24
  4. Study sites: 28 to 25v28
  5. Secondary endpoints: details revised at 11 of 11 entriesv27
  6. Study sites revised (28)v26 See this version in full on ClinicalTrials.gov ↗
  7. Study sites: 27 to 28v25
  8. Re-verified, no change to tracked fieldsv24
  9. Study sites: 24 to 27v23
  10. Study sites revised (24)v22 See this version in full on ClinicalTrials.gov ↗
  11. Trial status: Recruiting to Enrolling by Invitation Site details revised at 24 of 24 sitesv21 Show 1 more changeShow less
    • Site details revised at 24 of 24 sites
  12. Study sites: 22 to 24v20
  13. Study sites: 21 to 22v19
  14. Study sites: 20 to 21v18
  15. Study sites: 19 to 20v17
  16. Study sites: 18 to 19v16
  17. Study sites: 16 to 18v15
  18. Study sites: 15 to 16v14
  19. Study sites: 12 to 15v13
  20. Study sites: 10 to 12v12
  21. Study sites: 9 to 10v11
  22. Study sites: 8 to 9v10
  23. Study sites: 6 to 8v9
  24. Study sites: 5 to 6v8
  25. Site details revised at 1 of 5 sitesv7
  26. Site details revised at 1 of 5 sitesv6
  27. Study sites: 4 to 5v5
  28. Site details revised at 1 of 4 sitesv4
  29. Start date changed from estimate of Mar 26, 2023 to Apr 26, 2023v3
  30. Study sites: 1 to 4v2
  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 goal of this trial 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 acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen. A separate sub-study in patients with congenital HO is detailed under NCT06760546.
Trial Details
NCT Number NCT05774756
Lead Sponsor Rhythm Pharmaceuticals, Inc.
Conditions Hypothalamic Obesity
Enrollment 143 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov