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RM-493-034: Setmelanotide in MC4R Study
This study is no longer recruiting.
The purpose of this study is to find out if an investigational drug called setmelanotide (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 & Criteria
IRB #:
21-019201
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
Study Phase:
Phase II
Eligible Age Range:
6 - 65 Years
Gender:
All
Visit Criteria
There are four (4) parts to this trial: Screening Period, Open-Label Treatment Period, Double-Blind Treatment Period and Follow-Up Period.
Screening Period (Up to 8 Weeks): During the initial Screening Period we will assess eligibility. You will complete 1 in-person study visit.
Open-Label Treatment Period (Up to 16 Weeks): If you are confirmed to be eligible for the study, then you will start the 16-Week open-label treatment period. During this period, you will have up to 2 in-person study visits, up to 5 virtual visits, and 1 telephone call.
Double-Blind Treatment Period (Up to 24 Weeks): If you are found to be eligible you may continue to the double-blind treatment period which will last for up to 24 weeks. During this period, you will have up to 4 in-person visits, up to 4 virtual visits and 1 phone call.
Follow-Up Period (4 Weeks): You will have an end-of-study visit completed over the phone approximately 4 weeks after the double-blind treatment period ends. The study doctor will also check whether the study drug works for you. If so, you may have an option to enter an extension study.
Leader
