OPK-88006 in Healthy Adults and People with Presumed MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part Phase 1/2 interventional trial of OPK-88006. Part A is an open-label single-ascending-dose study in healthy adults to assess safety and pharmacokinetics. Part B is a double-blind, randomized, placebo-controlled multiple-ascending-dose study in adults with presumed MASH to evaluate safety, pharmacodynamics, and PD changes related to the condition compared with placebo. The study aims to identify dose ranges and observe how the drug affects metabolic and liver-related biomarkers. Primary endpoints focus on safety and PK, with exploratory PD assessments in MASH participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• OPKO study site
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: OPKO Health
• Email: contact@opko.com
• Phone: 305-575-4100

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.