Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
← catalyst calendarNCT07512427 · readout ≤ 498 d
Sponsored by OPKO Health, Inc. (industry) · OPK — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
30estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-24 | estimated | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- MASH
Interventions
- Drug: OPK-88006
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFSAD - OPK-88006 maximum plasma concentration (Cmax)
measured 2 hours to 1 week
SAD - OPK-88006 Time to peak (Tmax)
measured 2 hours to 1 week
SAD - OPK-88006 Elimination half-life (T1/2)
measured 10 hours to 200 hours
SAD - Frequency of treatment emergent adverse events (TEAE)
measured Up to 2 weeks
MAD - Frequency of treatment emergent adverse events (TEAE)
measured Up to 20 weeks
MAD - Change in body weight
measured Up to 17 weeks
MAD - Change in fasting lipids
measured Up to 17 weeks
MAD - Change in liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
measured Up to 17 weeks
MAD - Change in liver stiffness with Vibration-controlled Transient Elastography (VCTE)
measured Up to 17 weeks
MAD - Change in fibrosis markers measured by Enhanced Liver Fibrosis (ELF) score
measured Up to 17 weeks
MAD - Change in hepatic fat measured by MRI-PDFF
measured Up to 17 weeks
Permalink · OPK's whole pipeline · Catalyst calendar · Every registered study · What changed