Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RM-718 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| RM-718 (Cohort A1) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A2) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A3) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A4) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A5) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A6) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A7) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A8) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort A9) | EXPERIMENTAL | Single dose of RM-718 (4) or placebo (2) |
| RM-718 (Cohort B1) | EXPERIMENTAL | Multiple ascending doses of RM-718 (4) or placebo (2) |
| RM-718 (Cohort B2) | EXPERIMENTAL | Multiple ascending doses of RM-718 (4) or placebo (2) |
| RM-718 (Cohort B3) | EXPERIMENTAL | Multiple ascending doses of RM-718 (4) or placebo (2) |
| RM-718 (Cohort B4) | EXPERIMENTAL | Multiple ascending doses of RM-718 (4) or placebo (2) |
| RM-718 (Cohort B5) | EXPERIMENTAL | Multiple ascending doses of RM-718 (4) or placebo (2) |
| RM-718 (Cohort B6) | EXPERIMENTAL | Multiple ascending doses of RM-718 (4) or placebo (2) |
| RM-718 (Cohort C1) | EXPERIMENTAL | Multiple ascending doses of RM-718 (30) |
| RM-718 (Cohort D1) | EXPERIMENTAL | Multiple ascending doses of RM-718 (up to 30) |
| Name | Type | Description |
|---|---|---|
| Part A: RM-718 or placebo (matched to specific RM-718 dose cohort) | DRUG | Single ascending dose of RM-718 or placebo (matched to specific RM-718 Part A dose cohort) |
| Part B: RM-718 or placebo (matched to specific RM-718 dose cohort) | DRUG | Multiple ascending doses of RM-718 or placebo (matched to specific RM-718 Part B dose cohorts) |
| Part C: RM-718 | DRUG | Multiple ascending doses of RM-718 |
| Part D: RM-718 | DRUG | Multiple ascending doses of RM-718 |
Key Inclusion Criteria: Parts A and B: * Male and female subjects in good health aged 18-55 years of age at Screening. * Body mass index (BMI) ≥30 kg/m2. * Subjects who are medically healthy with normal or clinically insignificant screening results. * Subjects must use a highly effective form of c...
RM-718 is an investigational small molecule being developed for hypothalamic obesity, a rare disease in which damage to the hypothalamus causes severe weight gain. It is also being studied in patients with MC4R pathway impairment, including Prader-Willi syndrome. RM-718 has not been approved for any use and remains in clinical development.
RM-718 targets MC4R, the melanocortin 4 receptor. MC4R is a receptor in the melanocortin pathway that regulates appetite and energy balance. RM-718 is a small molecule designed to act on this receptor, which is relevant to hypothalamic obesity and other conditions involving MC4R pathway impairment.
RM-718 is being developed by Rhythm Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker RYTM. Rhythm is a biopharmaceutical company focused on rare diseases of the melanocortin pathway. The company is running the clinical program for RM-718 in hypothalamic obesity and related MC4R pathway conditions.
RM-718 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes a randomized, double-blind, controlled study. RM-718 has received RMAT designation from the FDA, which is a designation for regenerative medicine therapies.
RM-718 is being studied in the Phase 1 trial NCT06239116, titled A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment. The trial is active but not recruiting, with an enrollment of 111 participants. It includes healthy volunteers and patients with hypothalamic obesity or Prader-Willi syndrome, and is conducted in the United States.
Yes. RM-718 is also referred to as Part C: RM-718 and Part D: RM-718. These are alternative names for the same investigational drug candidate. Searches for any of these names refer to the MC4R-targeted small molecule being developed by Rhythm Pharmaceuticals for hypothalamic obesity and related conditions.