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

NCT05183802 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2022-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Bardet-Biedl Syndrome (BBS)
  • Obesity

Interventions

DRUG

Setmelanotide, administered subcutaneously [SC], once daily.

Dosing based on age, and titrated from starting dose to target dose.

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Linda Shapiro, M.D., Ph.D. · Chief Medical Officer, Rhythm Pharmaceuticals

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05183802 on ClinicalTrials.gov