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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.