Long-Term Setmelanotide for Obesity

Recruiting at30 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Rhythm Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

Research Team

David Meeker, MD

Principal Investigator

Rhythm Pharmaceuticals, Inc.

Eligibility Criteria

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

If the patient exhibited a clinically meaningful benefit (efficacy) to setmelanotide treatment, and would benefit from continued treatment, he/she may be eligible for the extension study, after discussion with the Sponsor.

I am over 2 years old and have safely benefited from a prior setmelanotide trial.

Agree to use a highly effective form of contraception throughout the trial

Exclusion Criteria

You have thought about or attempted suicide in the past.

I or my close family have had melanoma, or I have a history of albinism.

You are pregnant or breastfeeding.

Treatment Details

Interventions

• Setmelanotide (Melanocortin 4 Receptor (MC4R) Agonist)

Trial Overview The trial is testing the long-term safety and effectiveness of continued setmelanotide treatment in those who've shown positive results from earlier trials. Setmelanotide targets specific genetic causes of obesity by acting on a pathway that controls weight.

Participant Groups

Group I: Setmelanotide Experimental Treatment 1 Intervention

Once daily subcutaneous injection

Setmelanotide is already approved in Canada for the following indications:

Approved in Canada as Imcivree for:

• 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).

Who Is Running the Clinical Trial?

Rhythm Pharmaceuticals, Inc.

Lead Sponsor

Trials

31

Recruited

10,400+