NCT07512427

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	OPK-88006	Administered by subcutaneous injection
DRUG	Placebo	Administered by subcutaneous injection

Timeline

• Start date: 2026-12-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Regulatory

• FDA-regulated drug study