NCT07512427RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 24 Jul 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- OPKO Health, Inc.
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07512427
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 24 Jul 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).
- Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).
Other illness
- Significant uncontrolled medical or psychiatric history.
- History of pancreatitis, cancer (within 5 years), or substance misuse.
- 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.
Lab values
- Clinically significant abnormal labs (e.g., liver enzymes, low platelets) or ECG findings.
- Clinically significant abnormal labs (e.g., elevated liver enzymes, HbA1c ≥9.5%) or ECG findings.
Other
- Pregnant, lactating, or planning pregnancy.
- Part B (MAD)
- Pregnant, lactating, or planning pregnancy.
Who the study is looking for
- 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.
- 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.
Criteria the registry did not label
- Part A (SAD)
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OPKO study site Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.