MASHPhase 1/2NCT07512427
Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
A Phase 1/2 study testing OPK-88006 in people with MASH, run by OPKO Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- MASH
- What is being tested?
- OPK-88006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2026to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OPKO study site
Miami, Florida, 33143
OPKO Site
About this study
Official title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (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.
- Conditions
- MASH
- Being tested
- OPK-88006, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPK-88006Drug
Administered by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SAD - Cohort 1 OPK-88006 | Experimental | Not described Receives: Drug: OPK-88006 |
| SAD - Cohort 2 OPK-88006 | Experimental | Not described Receives: Drug: OPK-88006 |
| SAD - Cohort 3 OPK-88006 | Experimental | Not described Receives: Drug: OPK-88006 |
| MAD - OPK-88006/Placebo | Experimental | Not described Receives: Drug: OPK-88006; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD - OPK-88006 maximum plasma concentration (Cmax)
To assess Cmax of OPK-88006 after a single dose
Measured: 2 hours to 1 week
SAD - OPK-88006 Time to peak (Tmax)
To assess Tmax of OPK-88006 after a single dose
Measured: 2 hours to 1 week
SAD - OPK-88006 Elimination half-life (T1/2)
To assess T1/2 of OPK-88006 after a single dose
Measured: 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.
Measured: 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.
Measured: Up to 20 weeks
MAD - Change in body weight
Change from baseline in body weight (measured in kilograms) during the drug administration.
Measured: Up to 17 weeks
MAD - Change in fasting lipids
Change from baseline in fasting lipid profile parameters
Measured: Up to 17 weeks
MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Change from baseline in ALT and AST
Measured: Up to 17 weeks
MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE)
Change from baseline measured by VCTE
Measured: Up to 17 weeks
MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score
Change from baseline in ELF score
Measured: Up to 17 weeks
MAD - Change in hepatic fat measured by MRI-PDFF
Change from baseline in hepatic fat
Measured: Up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start24 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512427
- Sponsor's protocol ID
- OPK-88006-101
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants
- ClinicalTrials.gov ID
- NCT07512427
- Acronym / sponsor ID
- OPK-88006-101
- Conditions
- MASH
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Adults aged 18-75 years.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPK-88006Administered by subcutaneous injection | Drug | MAD - OPK-88006/Placebo, SAD - Cohort 1 OPK-88006, SAD - Cohort 2 OPK-88006, SAD - Cohort 3 OPK-88006 |
| PlaceboAdministered by subcutaneous injection | Drug | MAD - OPK-88006/Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OPK-88006 in people with MASH, run by OPKO Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OPKO Health (305-575-4100, contact@opko.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD - OPK-88006 maximum plasma concentration (Cmax) (time frame: 2 hours to 1 week). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.