Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OPK-88006, Placebo.
- Who it may be relevant to
- Registry conditions: MASH. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants
Overview
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
- Drug OPK-88006
Administered by subcutaneous injection - Drug Placebo
Administered by subcutaneous injection
Primary outcome measures
- SAD - OPK-88006 maximum plasma concentration (Cmax) [Time frame: 2 hours to 1 week]
- SAD - OPK-88006 Time to peak (Tmax) [Time frame: 2 hours to 1 week]
- SAD - OPK-88006 Elimination half-life (T1/2) [Time frame: 10 hours to 200 hours]
- SAD - Frequency of treatment emergent adverse events (TEAE) [Time frame: Up to 2 weeks]
- MAD - Frequency of treatment emergent adverse events (TEAE) [Time frame: Up to 20 weeks]
- MAD - Change in body weight [Time frame: Up to 17 weeks]
- MAD - Change in fasting lipids [Time frame: Up to 17 weeks]
- MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) [Time frame: Up to 17 weeks]
- MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE) [Time frame: Up to 17 weeks]
- MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score [Time frame: Up to 17 weeks]
Eligibility 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- OPKO study site — Miami
Identifiers
NCT: NCT07512427 · OPK-88006-101