A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 9, 2020

Primary Completion Date

April 17, 2021

Study Completion Date

April 17, 2021

Conditions
Renal Insufficiency
Interventions
DRUG

Setmelanotide

Setmelanotide will be administered as a single SC dose of 2.0 mg on Day 1. A dose higher than 2.0 mg will not be used during the study. Dose may be lowered based on safety data.

Trial Locations (4)

32809

Orlando Clinical Research Center, Orlando

33136

University of Miami, Miami

37920

Alliance for Multispecialty Research, LLC, Knoxville

54449

Marshfield Clinic Research Institute, Marshfield

All Listed Sponsors
lead

Rhythm Pharmaceuticals, Inc.

INDUSTRY

NCT04348175 - A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment | Biotech Hunter | Biotech Hunter