Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
ConditionMASH
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOPKO Health, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- OPK-88006
- Placebo
Treatment groups
30 Participants
are divided into 4 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
OPKO Health, Inc.
Lead sponsor
Source ClinicalTrials.gov