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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: MASH
• Intervention / Treatment: Drug: Placebo; Drug: OPK-88006

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: OPKO Health; Phone Number: 305-575-4100; Email: contact@opko.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD - Cohort 1 OPK-88006	Drug: OPK-88006; Administered by subcutaneous injection
Experimental: SAD - Cohort 2 OPK-88006	Drug: OPK-88006; Administered by subcutaneous injection
Experimental: SAD - Cohort 3 OPK-88006	Drug: OPK-88006; Administered by subcutaneous injection
Experimental: MAD - OPK-88006/Placebo	Drug: Placebo; Administered by subcutaneous injection; Drug: OPK-88006; Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAD - OPK-88006 maximum plasma concentration (Cmax)	To assess Cmax of OPK-88006 after a single dose	2 hours to 1 week
SAD - OPK-88006 Time to peak (Tmax)	To assess Tmax of OPK-88006 after a single dose	2 hours to 1 week
SAD - OPK-88006 Elimination half-life (T1/2)	To assess T1/2 of OPK-88006 after a single dose	10 hours to 200 hours
SAD - Frequency of treatment emergent adverse events (TEAE)	TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to 2 weeks
MAD - Frequency of treatment emergent adverse events (TEAE)	TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to 20 weeks
MAD - Change in body weight	Change from baseline in body weight (measured in kilograms) during the drug administration.	Up to 17 weeks
MAD - Change in fasting lipids	Change from baseline in fasting lipid profile parameters	Up to 17 weeks
MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)	Change from baseline in ALT and AST	Up to 17 weeks
MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE)	Change from baseline measured by VCTE	Up to 17 weeks
MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score	Change from baseline in ELF score	Up to 17 weeks
MAD - Change in hepatic fat measured by MRI-PDFF	Change from baseline in hepatic fat	Up to 17 weeks

Collaborators and Investigators

• Sponsor: OPKO Health, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OPK-88006-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No