Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants

OPKO Health, Inc.

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.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: Yes

Detailed 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…

Interventions

Drug
OPK-88006
Administered by subcutaneous injection
Drug
Placebo
Administered by subcutaneous injection

Location

OPKO study site
Miami, Florida

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions