Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants

Two-part Phase 1/2 study of OPK-88006, including an open-label SAD phase in healthy participants and a double-blind, randomized, placebo-controlled MAD phase in participants with presumed MASH, to evaluate safety, PK, and MASH related pharmacodynamic changes compared to placebo.

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 history.
• History of pancreatitis, cancer (within 5 years), or substance misuse.
• Clinically significant abnormal labs (e.g., liver enzymes, low platelets) or ECG findings.
• Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).
• Pregnant, lactating, or planning pregnancy.

Part B (MAD)

Inclusion Criteria:

• Adults aged 18-75 years.
• Presumed MASH (defined by metabolic risk factors and specific liver tests).
• BMI ≥27 and ≤40 kg/m² with stable weight.
• Willing to comply with contraception, trial procedures, and stable diet/exercise.

Exclusion Criteria:

• Significant uncontrolled medical or psychiatric history.
• History of other liver diseases, cirrhosis, or hepatic decompensation.
• History of pancreatitis, cancer (within 5 years), or substance misuse.
• Clinically significant abnormal labs (e.g., elevated liver enzymes, HbA1c ≥9.5%) or ECG findings.
• Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).
• Pregnant, lactating, or planning pregnancy.