Long-Term Setmelanotide for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the Melanocortin-4 (MC4) receptor in the leptin-melanocortin pathway.
Who Is on the Research Team?
David Meeker, MD
Principal Investigator
Rhythm Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for patients aged 2 or older who have previously been treated with setmelanotide for obesity linked to genetic defects and saw benefits. They must be able to follow the study plan, use effective birth control, and not have significant liver disease, severe kidney issues, certain psychiatric disorders, a history of melanoma or suicidal behavior.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants continue receiving setmelanotide treatment via once daily subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term extension
Exploration of long-term safety and tolerability of setmelanotide
What Are the Treatments Tested in This Trial?
Interventions
- Setmelanotide
Setmelanotide is already approved in United States, European Union, Canada for the following indications:
- Chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
- Chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
- Chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
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Who Is Running the Clinical Trial?
Rhythm Pharmaceuticals, Inc.
Lead Sponsor