A new clinical study is now enrolling individuals with Prader-Willi syndrome (PWS), offering families the opportunity to explore a potential new treatment for obesity and hyperphagia.
RM-718 is an investigational medication taken as a once-weekly injection and is currently being investigated in several syndromes. RM-718, Part D, will evaluate the drug’s safety and ability to treat hyperphagia and obesity in adolescents and adults with PWS ages 12 to 65 years old.
The study will enroll up to 30 participants at 4 clinical trial sites:
- Chicago, IL
- Birmingham, AL
- Salt Lake City, UT
- San Diego, CA
Overview of the Rm-718 Study, Part D
This study is an open-label investigation, meaning every participant will receive the active study drug, RM-718, as a weekly injection.
Participation will last about 8 months. During the study:
- You will receive a weekly injection of RM-718 for 26 weeks. RM-718 is injected under the skin. If tolerated, the dose will be gradually increased up to the target level.
- Including the screening, treatment, and follow-up periods, your participation in the study will last up to 33 weeks.
- You can expect up to 29 visits, either at the clinic or at home with a visiting nurse.
If you are eligible, you may have the option to continue to receive RM-718 after the study in a Long-Term Extension Period.
All study-related care—including the medication, visits, and tests—is provided at no cost.
What are the Minimum Eligibility Criteria for the RM-718 Study?
This study requires participants to be:
- Ages 12 to 65 years
- Have a confirmed diagnosis of PWS
- Minimum BMI:
- 30 or higher (adults)
- 95th percentile or higher (under 18)
The study team will review additional criteria during screening.
Considering Participation?
Deciding whether to join a clinical trial is deeply personal. It’s important to understand that this study drug is investigational, meaning it is not yet FDA-approved. There could be side effects, which will be closely monitored throughout the study.
Some families choose to participate because they want access to new approaches; others are motivated by the opportunity to contribute to research that could help the entire PWS community. Participation is always completely voluntary, and you can leave the study at any time, for any reason.
If you’re interested in participating, the next step is to learn more.
Where Can You Get More Information?
- Download the RM-718 participation brochure
- View the trial listing on ClinicalTrials.gov (NCT06239116)
- Email questions or request a screening: patientadvocacy@rhythmtx.com
