Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06239116 | A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment | PHASE1 | RECRUITING | 150 | — | — | Mar 5, 2024 | Nov 1, 2028 | Dec 22, 2025 | 7 | United States |
| 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...