NCT07512427 · OPKO Health, Inc.
Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
What this study is about
Two-part Phase 1/2 study of OPK-88006, including an where both patients and doctors know the treatment given SAD phase in healthy participants and a where neither patients nor doctors know which treatment is given, randomly assigned, compared against an inactive treatment MAD phase in participants with presumed MASH, to evaluate safety, PK, and MASH related how the drug affects the body changes compared to placebo.
View original scientific description
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.
Interventions
DRUG
OPK-88006
Administered by subcutaneous injection
DRUG
Placebo
Administered by subcutaneous injection
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations