# An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)

> **NCT05183802** · — · APPROVED_FOR_MARKETING · sponsor: **Rhythm Pharmaceuticals, Inc.**

## Conditions studied

- Bardet-Biedl Syndrome (BBS)
- Obesity

## Interventions

- **DRUG:** Setmelanotide, administered subcutaneously [SC], once daily.

## Key facts

- **NCT ID:** NCT05183802
- **Lead sponsor:** Rhythm Pharmaceuticals, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** EXPANDED_ACCESS
- **Status:** APPROVED_FOR_MARKETING
- **Start date:** —
- **Primary completion:** —
- **Final completion:** —
- **Target enrollment:** — (—)
- **Last updated:** 2022-08-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05183802

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05183802, "An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05183802. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*