RecruitingPhase 1Phase 2NCT07512427

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

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants


Sponsor

OPKO Health, Inc.

Enrollment

30 participants

Start Date

Jul 24, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called OPK-88006 and a drug called Placebo for people with mash. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOPK-88006

Administered by subcutaneous injection

DRUGPlacebo

Administered by subcutaneous injection


Locations(1)

OPKO study site

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT07512427


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