NCT07512427PHASE1, PHASE2RecruitingAccepts Healthy Volunteers
Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
OPKO Health, Inc.
Start Date
7/24/2026
Completion Date
12/1/2027
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.
Eligibility Criteria
Age Range: 18 years to 75 years
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.
Interventions
DRUG
OPK-88006
DRUG