NCT05194124View on ClinicalTrials.gov

Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

PHASE3CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

December 21, 2021

Primary Completion Date

October 19, 2023

Study Completion Date

October 19, 2023

Conditions
Bardet-Biedl SyndromePOMC Deficiency
Interventions
DRUG

Setmelanotide 2 mg

Administered as SC injection

DRUG

Setmelanotide 2.5 mg

Administered as SC injection

DRUG

Setmelanotide 3 mg

Administered as SC injection

DRUG

Setmelanotide 20 mg

Administered as SC injection

DRUG

Setmelanotide 25 mg

Administered as SC injection

DRUG

Setmelanotide 30 mg

Administered as SC injection

Trial Locations (7)

13353

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin

54449

Marshfield Clinic Research Institute, Marshfield

85258

Honor Health Research Institute, Scottsdale

T6G 2E1

Alberta Health Services, Edmonton

3015 CE

Erasmus MC, Rotterdam

00935

UPR Medical Sciences Campus, Rio Piedras

CA2 0QQ

Addenbrooke's Hospital, Cambridge

All Listed Sponsors
lead

Rhythm Pharmaceuticals, Inc.

INDUSTRY

NCT05194124 - Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway | Biotech Hunter | Biotech Hunter