RecruitingMASH
Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: OPKO Health, Inc.
You may qualify if…
- ✓ 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.
- ✓ 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.
You may not qualify if…
- ✕ 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)
- ✕ Significant uncontrolled medical or psychiatric history.
- ✕ History of other liver diseases, cirrhosis, or hepatic decompensation.
Where it's recruiting
Florida
Miami
Source: ClinicalTrials.gov · NCT07512427 · last updated 2026-07-31