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

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.