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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
SAD - OPK-88006 maximum plasma concentration (Cmax) — 2 hours to 1 week To assess Cmax of OPK-88006 after a single dose
SAD - OPK-88006 Time to peak (Tmax) — 2 hours to 1 week To assess Tmax of OPK-88006 after a single dose
SAD - OPK-88006 Elimination half-life (T1/2) — 10 hours to 200 hours To assess T1/2 of OPK-88006 after a single dose
SAD - Frequency of treatment emergent adverse events (TEAE) — Up to 2 weeks TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
MAD - Frequency of treatment emergent adverse events (TEAE) — Up to 20 weeks TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
MAD - Change in body weight — Up to 17 weeks Change from baseline in body weight (measured in kilograms) during the drug administration.
MAD - Change in fasting lipids — Up to 17 weeks Change from baseline in fasting lipid profile parameters
MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) — Up to 17 weeks Change from baseline in ALT and AST
MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE) — Up to 17 weeks Change from baseline measured by VCTE
MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score — Up to 17 weeks Change from baseline in ELF score
MAD - Change in hepatic fat measured by MRI-PDFF — Up to 17 weeks Change from baseline in hepatic fat
Trial sites (1)
Facility
City
Region
Status
OPKO study site
Miami
Florida
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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