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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07512427 | Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants | PHASE1 | NOT YET_RECRUITING | 30 | — | — | Dec 1, 2026 | Dec 1, 2027 | Apr 6, 2026 | - | — |
To assess Cmax of OPK-88006 after a single dose
To assess Tmax of OPK-88006 after a single dose
To assess T1/2 of OPK-88006 after a single dose
TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Change from baseline in body weight (measured in kilograms) during the drug administration.
Change from baseline in fasting lipid profile parameters
Change from baseline in ALT and AST
Change from baseline measured by VCTE
Change from baseline in ELF score
Change from baseline in hepatic fat
| Arm | Type | Description |
|---|---|---|
| SAD - Cohort 1 OPK-88006 | EXPERIMENTAL | - |
| SAD - Cohort 2 OPK-88006 | EXPERIMENTAL | - |
| SAD - Cohort 3 OPK-88006 | EXPERIMENTAL | - |
| MAD - OPK-88006/Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| OPK-88006 | DRUG | Administered by subcutaneous injection |
| Placebo | DRUG | Administered by subcutaneous injection |
Part A (SAD) Inclusion Criteria: * Adults aged 18-65 years. * BMI ≥27 and ≤35 kg/m². * Good general health per investigator assessment. * Willing to comply with contraception, trial procedures, and stable diet/exercise. Exclusion Criteria: * Significant uncontrolled medical or psychiatric histor...