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RecruitingAccepts healthy volunteersPhase 1/Phase 2

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

OPKO Health, Inc. · NCT07512427

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
30
US sites recruiting
1
Study start
July 24, 2026
Record last updated
August 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: OPK-88006; Placebo

Conditions: MASH

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • OPKO study site

    Miami, FL 33143

    Site contact: OPKO Site

Study contacts (from the official record)

  • OPKO Health · 305-575-4100 · contact@opko.com
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Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants (NCT07512427) | Bored Studies