Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OPK-88006 · 1 trial · 1 indication
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...
OPK-88006 is an investigational small molecule being developed for the treatment of MASH, or metabolic dysfunction-associated steatohepatitis. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in a Phase 1/2 trial that includes healthy participants and those with presumed MASH.
OPK-88006 targets the GLP-1 and glucagon receptors. As a receptor-targeting small molecule, it is designed to modulate pathways involved in metabolic regulation, which is relevant to its intended use in MASH. The drug is being evaluated in a Phase 1 clinical trial to assess its effects.
OPK-88006 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The drug is currently in Phase 1 clinical development for the treatment of MASH, and it is not yet approved for commercial use.
OPK-88006 is in Phase 1 clinical development. It is being studied in a Phase 1/2 trial that is currently recruiting participants. The drug is investigational and has not received FDA approval. The trial is designed to evaluate the drug in healthy volunteers and participants with presumed MASH.
OPK-88006 is being studied in a Phase 1/2 trial with the identifier NCT07512427, titled 'Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants.' This randomized, double-blind, controlled trial is recruiting 30 participants in the United States, with a minimum age of 18 years.