[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632341":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":11,"centralContacts":33,"locations":11,"responsibleParty":39,"collaborators":11,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":11,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":11},{"fullName":5,"class":6},"OPKO Health, Inc.","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"SAD - Cohort 1 OPK-88006","EXPERIMENTAL",null,[13],"Drug: OPK-88006",{"label":15,"type":10,"description":11,"interventionNames":16},"SAD - Cohort 2 OPK-88006",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"SAD - Cohort 3 OPK-88006",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"MAD - OPK-88006\u002FPlacebo",[13,23],"Drug: Placebo",[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","OPK-88006","Administered by subcutaneous injection",[21,9,15,18],{"type":26,"name":31,"description":28,"armGroupLabels":32,"otherNames":11},"Placebo",[21],[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"OPKO Health","CONTACT","305-575-4100","contact@opko.com",{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632341","phase-1-phase-12-study-of-opk-88006-in-healthy-and-presumed-mash-participants-100632341",false,"NCT07512427","Phase 1\u002F2 Study of OPK-88006 in Healthy and Presumed MASH Participants","Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of OPK-88006 in Healthy and Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) Participants","Part A (SAD)\n\nInclusion Criteria:\n\n* Adults aged 18-65 years.\n* BMI ≥27 and ≤35 kg\u002Fm².\n* Good general health per investigator assessment.\n* Willing to comply with contraception, trial procedures, and stable diet\u002Fexercise.\n\nExclusion Criteria:\n\n* Significant uncontrolled medical or psychiatric history.\n* History of pancreatitis, cancer (within 5 years), or substance misuse.\n* Clinically significant abnormal labs (e.g., liver enzymes, low platelets) or ECG findings.\n* Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).\n* Pregnant, lactating, or planning pregnancy.\n\nPart B (MAD)\n\nInclusion Criteria:\n\n* Adults aged 18-75 years.\n* Presumed MASH (defined by metabolic risk factors and specific liver tests).\n* BMI ≥27 and ≤40 kg\u002Fm² with stable weight.\n* Willing to comply with contraception, trial procedures, and stable diet\u002Fexercise.\n\nExclusion Criteria:\n\n* Significant uncontrolled medical or psychiatric history.\n* History of other liver diseases, cirrhosis, or hepatic decompensation.\n* History of pancreatitis, cancer (within 5 years), or substance misuse.\n* Clinically significant abnormal labs (e.g., elevated liver enzymes, HbA1c ≥9.5%) or ECG findings.\n* Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).\n* Pregnant, lactating, or planning pregnancy.",true,"ALL","18 Years","75 Years",{"count":53,"type":54},30,"ESTIMATED","INTERVENTIONAL",[57,58],"PHASE1","PHASE2","Two-part Phase 1\u002F2 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.",[61],"MASH","NOT_YET_RECRUITING","2026-03-30",{"date":65,"type":66},"2026-04-06","ACTUAL",{"date":68,"type":54},"2026-12",{"date":70,"type":54},"2027-12",{"name":5,"class":6}]