Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants (NCT07512427)
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (16 items).
Location: OPKO study site — Miami, Florida
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- OPKO study site — Miami, Florida
📞 Contact the Study Coordinator
Phone: (305) 575-4100
Email: contact@opko.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.