Last reviewed · How we verify
NCT05183802
An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)
trial testing Setmelanotide, administered subcutaneously [SC], once daily. in Bardet-Biedl Syndrome (BBS). Approved for marketing.
Quick facts
| Lead sponsor | Rhythm Pharmaceuticals, Inc. |
|---|---|
| Status | APPROVED FOR MARKETING |
| Study type | EXPANDED_ACCESS |
Drugs / interventions tested
- Setmelanotide, administered subcutaneously [SC], once daily. — full drug profile →
Conditions studied
- Bardet-Biedl Syndrome (BBS) — all drugs for Bardet-Biedl Syndrome (BBS) →
- Obesity — all drugs for Obesity →
Sponsor
Rhythm Pharmaceuticals, Inc. — full company profile →
Who can join
6 and older, any sex, with Bardet-Biedl Syndrome (BBS) or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An open-label, single-arm, multicenter, Expanded Access Protocol \[EAP\] designed to provide treatment access to setmelanotide (3 mg, administered subcutaneously \[SC\], once daily) for eligible patients with BBS who have no alternative treatment options. All patients will continue to receive setmelanotide at the discretion of the Treating Physician and while they are deriving clinical benefit.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05183802
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Rhythm Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07156578 — A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO) · Phase 2 · enrolling by invitation
- NCT06760546 — A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) · Phase 3 · recruiting
- NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
- NCT06596135 — Open-Label Extension Study of Setmelanotide · Phase 3 · enrolling by invitation
- NCT06046443 — A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05183802 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rhythm Pharmaceuticals, Inc.
- Last refreshed: 10 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05183802.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing