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.