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

NCT07512427 | Recruiting Phase 1 FDA Drug

• 1 other identifier: OPK-88006-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (4)

SAD - Cohort 1 OPK-88006

EXPERIMENTAL

Drug: OPK-88006

SAD - Cohort 2 OPK-88006

EXPERIMENTAL

Drug: OPK-88006

SAD - Cohort 3 OPK-88006

EXPERIMENTAL

Drug: OPK-88006

MAD - OPK-88006/Placebo

EXPERIMENTAL

Drug: OPK-88006; Drug: Placebo

Interventions

OPK-88006 DRUG

Administered by subcutaneous injection

MAD - OPK-88006/Placebo; SAD - Cohort 1 OPK-88006; SAD - Cohort 2 OPK-88006; SAD - Cohort 3 OPK-88006

Placebo DRUG

Administered by subcutaneous injection

MAD - OPK-88006/Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• 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).

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

OPKO study site

Miami, Florida, 33143, United States

RECRUITING

Central Study Contacts

OPKO Health

CONTACT

305-575-4100; contact@opko.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: April 6, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

US (1)