deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03746522

Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity

A Phase 3 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity

Sponsor: Rhythm Pharmaceuticals, Inc.

Updated 23 times since 2018 Last updated: Nov 9, 2023 Started: Nov 23, 2018 Primary completion: Nov 16, 2020 Completion: Mar 8, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03746522, this PHASE3 trial focuses on Alström Syndrome (AS) and Bardet Biedl Syndrome (BBS) and remains completed. Sponsored by Rhythm Pharmaceuticals, Inc., it has been updated 23 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Jan 2024 · 28 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 23 months · monthly snapshot

Change History

23 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE3

  4. Sep 2021 — Jan 2024 [monthly]

    Completed PHASE3

  5. Jun 2021 — Sep 2021 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

Show 18 earlier versions
  1. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  2. Mar 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  3. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE3

  4. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  6. May 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  7. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  8. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  9. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  10. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  11. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  12. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  13. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  14. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  15. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  16. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  17. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  18. Dec 2018 — Apr 2019 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Rhythm Pharmaceuticals, Inc.
Data source: Rhythm Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .