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

Purpose

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.

Condition

  • MASH

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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: OPK-88006
    Administered by subcutaneous injection
  • Drug: Placebo
    Administered by subcutaneous injection

Recruiting Locations

OPKO study site
Miami, Florida 33143
Contact:
OPKO Site

More Details

Status
Recruiting
Sponsor
OPKO Health, Inc.

Study Contact

OPKO Health
305-575-4100
contact@opko.com