Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: MASH

In brief

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.

Key facts

Study ID

NCT07512427

Run by

OPKO Health, Inc.

People needed

30

Starts

2026-07-24

Expected to finish

2027-12-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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.

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)
• 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.

Where it is running

• OPKO study site — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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