Recruiting

Phase 1

Phase 2

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

Sponsor:

OPKO Health, Inc.

Code:

NCT07512427

Conditions

MASH

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

OPK-88006

Placebo

Study Details

Brief summary:

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.

Conditions

MASH

Study ID

NCT07512427

Start date

Jul 24, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAD - Cohort 1 OPK-88006

experimental: SAD - Cohort 2 OPK-88006

experimental: SAD - Cohort 3 OPK-88006

experimental: MAD - OPK-88006/Placebo

Interventions

OPK-88006

Administered by subcutaneous injection

Placebo

Administered by subcutaneous injection

Primary outcome measure

SAD - OPK-88006 maximum plasma concentration (Cmax) [ Time Frame: 2 hours to 1 week ]
SAD - OPK-88006 Time to peak (Tmax) [ Time Frame: 2 hours to 1 week ]
SAD - OPK-88006 Elimination half-life (T1/2) [ Time Frame: 10 hours to 200 hours ]
SAD - Frequency of treatment emergent adverse events (TEAE) [ Time Frame: Up to 2 weeks ]
MAD - Frequency of treatment emergent adverse events (TEAE) [ Time Frame: Up to 20 weeks ]
MAD - Change in body weight [ Time Frame: Up to 17 weeks ]
MAD - Change in fasting lipids [ Time Frame: Up to 17 weeks ]
MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) [ Time Frame: Up to 17 weeks ]
MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE) [ Time Frame: Up to 17 weeks ]
MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score [ Time Frame: Up to 17 weeks ]
MAD - Change in hepatic fat measured by MRI-PDFF [ Time Frame: Up to 17 weeks ]

Central Contacts and Locations

Central contacts

OPKO Health

305-575-4100 contact@opko.com

Locations

OPKO study site

Recruiting

Miami, Florida, United States, 33143

More Information

Sponsor

OPKO Health, Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OPKO Health, Inc. on 2026-08-27.