Rhythm is committed to developing safe and effective therapies for the treatment of rare genetic diseases of obesity. Setmelanotide is an investigational MC4R agonist being evaluated in clinical trials for the treatment of rare disorders of obesity and insatiable hunger.
Expanded access is the use of an investigational therapy outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options. Rhythm understands the interest in expanded access programs. We believe the most appropriate way to deliver on our commitment to patients is through participation in our clinical trials. Clinical trials, and the subsequent approval of a therapy, provide the best way to provide long-term access to as many patients as possible. For that reason, Rhythm does not currently offer an expanded access program.
If you have questions, we encourage you to speak with your doctor and potentially participate in one of Rhythm’s clinical trials. Please find information on clinical trials by searching for Rhythm at www.clinicaltrials.gov.
We recognize that not all patients will be able to enter these clinical trials, and as more information and clinical data on the safety and efficacy of our investigational therapies become available, our policy on expanded access will be reviewed regularly.
If you have any questions regarding this policy, please contact ExpandedAccess@rhythm.jpa.com. Rhythm anticipates responding to inquiries within 5 business days.