Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RM-493 · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| RM-493 | ACTIVE_COMPARATOR | Double blind RM-493 will be administered at a dose of 1 mg/24 hrs via subcutaneous infusion for 3 days |
| Placebo | PLACEBO_COMPARATOR | Double blind placebo will be administered via subcutaneous infusion for 3 days |
| Cohort 1: RM-493 SC Infusion 14 Days | ACTIVE_COMPARATOR | Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 14 days (1 panel, all male subjects) |
| Cohort 2: RM-493 SC Infusion 28 Days | ACTIVE_COMPARATOR | Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel) |
| Cohort 3: RM-493 SC Infusion 28 Days | ACTIVE_COMPARATOR | Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel) |
| Cohort 4: RM-493 SC Infusion 28 Days | ACTIVE_COMPARATOR | Double-blind RM-493 will be administered at a dose of 0.015 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel) |
| Cohort 5: RM-493 SC Injection 14 days | ACTIVE_COMPARATOR | Double-blind RM-493 will be administered at a dose of 0.0075 mg/kg every 12 hours via a subcutaneous injection for 14 days (1 panel) |
| Cohort 6: RM-493 SC Infusion 28 Days | ACTIVE_COMPARATOR | Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel, heterozygous MC4R subjects) |
| Cohort 1: Placebo SC Infusion 14 Days | PLACEBO_COMPARATOR | Double-blind Placebo will be administered via subcutaneous continuous infusion for 14 days (1 panel, all male subject) |
| Cohort 2: Placebo SC Infusion 28 Days | PLACEBO_COMPARATOR | Double-blind Placebo will be via subcutaneous continuous infusion for 14 days (1 panel) |
| Cohort 3: Placebo SC Infusion 28 Days | PLACEBO_COMPARATOR | Double-blind Placebo will be administered via subcutaneous continuous infusion for 28 days (1 panel) |
| Cohort 4: Placebo SC Infusion 28 Days | PLACEBO_COMPARATOR | Double-blind Placebo will be administered via subcutaneous continuous infusion for 28 days (1 panel) |
| Cohort 5: Placebo SC Injection 14 days | PLACEBO_COMPARATOR | Double-blind Placebo will be administered via a subcutaneous injection every 12 hours for 14 days (1 panel) |
| Cohort 6: Placebo SC Infusion 28 Days | PLACEBO_COMPARATOR | Double-blind Placebo will be administered via subcutaneous continuous infusion for 28 days (1 panel, heterozygous MC4R subjects) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Sterile solution (vehicle) for subcutaneous infusion |
| RM-493 | DRUG | Sterile solution (2mg/ml) for subcutaneous infusion |
* INCLUSION CRITERIA: Male and female subjects aged 18 to 50 years at screening who meet the following inclusion and exclusion criteria will be eligible for enrollment: * Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures...
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RM-493 is an investigational small molecule being developed for obesity and overweight. It is being studied in individuals who are obese, morbidly obese, or overweight. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
RM-493 is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker RYTM. The company is conducting clinical trials to evaluate the drug's safety and effects in obese and overweight populations.
RM-493 is in Phase 1 clinical development. It has completed two Phase 1 trials, and no active trials are currently listed. The drug remains investigational and has not received FDA approval for any indication.
RM-493 has been studied in two completed Phase 1 trials. NCT01867437 examined its effects on energy expenditure in obese individuals, enrolling 15 participants. NCT02431442 evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy, obese, non-diabetic volunteers, enrolling 57 participants.
No, RM-493 is not the same as setmelanotide. RM-493 is a distinct investigational small molecule developed by Rhythm Pharmaceuticals for obesity and overweight. It is in Phase 1 clinical trials and has not been approved by regulatory authorities.