OPKO study site
Miami, Florida, 33143, United States
Location status: Recruiting
Location contact
OPKO Site
CONTACT
Recruiting
NCT Number: NCT07512427
Phase 1/2 Study of OPK-88006 in Healthy and Presumed 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
OPK-88006
DrugAdministered by subcutaneous injection
Placebo
DrugAdministered by subcutaneous injection
Primary outcomes
-
SAD - OPK-88006 maximum plasma concentration (Cmax)
Time frame: 2 hours to 1 week
To assess Cmax of OPK-88006 after a single dose
-
SAD - OPK-88006 Time to peak (Tmax)
Time frame: 2 hours to 1 week
To assess Tmax of OPK-88006 after a single dose
-
SAD - OPK-88006 Elimination half-life (T1/2)
Time frame: 10 hours to 200 hours
To assess T1/2 of OPK-88006 after a single dose
-
SAD - Frequency of treatment emergent adverse events (TEAE)
Time frame: Up to 2 weeks
TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
-
MAD - Frequency of treatment emergent adverse events (TEAE)
Time frame: Up to 20 weeks
TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
-
MAD - Change in body weight
Time frame: Up to 17 weeks
Change from baseline in body weight (measured in kilograms) during the drug administration.
-
MAD - Change in fasting lipids
Time frame: Up to 17 weeks
Change from baseline in fasting lipid profile parameters
-
MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: Up to 17 weeks
Change from baseline in ALT and AST
-
MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE)
Time frame: Up to 17 weeks
Change from baseline measured by VCTE
-
MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score
Time frame: Up to 17 weeks
Change from baseline in ELF score
-
MAD - Change in hepatic fat measured by MRI-PDFF
Time frame: Up to 17 weeks
Change from baseline in hepatic fat
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
OPKO Health, Inc.
Industry
Registry information
Official study title
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 6, 2026
- Registry last updated
- Jul 31, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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