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RM-493-034: Setmelanotide in MC4R

RM-493-034: Setmelanotide in MC4R

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This study is now recruiting. Learn more about enrolling here.

Description

Thepurpose of this study is to find out if an investigational drug calledsetmelanotide (RM-493) can help control body weight in people with certain genetic modifications in their genes that play a key role in the regulation of body weight. Males and females, age 6 to 65, with certain genetic variants (MC4R pathway) may be eligible to participate.  If you are confirmed eligible for the study, then participation will last up to 48 Weeks.  Participants will complete Screening (Up to 8 Weeks), Open-Label Treatment (Up to 16 Weeks), and may be eligible to continue in the Double-Blind Treatment Period (Up to 24 Weeks).  Participants will complete research procedures including physical exams, blood draws, ECGs, and questionnaires.  Participant will also need to self-inject the study drug once daily for the duration of their participation. 

Eligibility and criteria


IRB Number:
21-019201
Eligible age range:
6 years - 65 years
Clinical trial phase:
Phase II
Official title:
A 2-stage (Open-Label Run-in followed by Randomized Withdrawal), Double-Blind, Placebo-Controlled, Phase 2 Study of Setmelanotide in Patients with Specific Gene Defects in the Melanocortin-4 Receptor Pathway
Smiling CHOP patient holding shopping bag

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