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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllOPKO Health, Inc.
NCT07512427 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • OPK-88006
  • Placebo
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Where

1 site
OPKO study site
Miami, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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