MASH
Conditions
Brief summary
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.
Interventions
DRUGOPK-88006
Administered by subcutaneous injection
DRUGPlacebo
Administered by subcutaneous injection
Sponsors
OPKO Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| MAD - Change in fasting lipids | Up to 17 weeks | Change from baseline in fasting lipid profile parameters |
| 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. |
Countries
United States
Contacts
CONTACTOPKO Health
Outcome results
None listed