{
  "schema_version": "1.0",
  "generated": "2026-05-14",
  "description": "Phase 3 MASH trial biomarker data mock",
  "trials": [
    {
      "trial_code": "MAESTRO-NASH",
      "drug": "resmetirom (THR-beta agonist)",
      "sponsor": "Madrigal",
      "phase": "3",
      "n": 966,
      "primary_endpoint": "MASH resolution + fibrosis improvement at week 52",
      "biomarkers_used": ["BMK-006", "BMK-008", "BMK-001", "BMK-014", "BMK-040", "BMK-019"],
      "korean_sites": 2,
      "status": "approved (FDA accelerated 2024)",
      "biomarker_data_summary": "MRI-PDFF >=30% reduction in 30% of resmetirom 80mg arm vs 9% placebo; PathAI AIM-NASH adjudication used"
    },
    {
      "trial_code": "HARMONY",
      "drug": "efruxifermin (FGF21 analog)",
      "sponsor": "Akero",
      "phase": "2b/3",
      "n": 128,
      "primary_endpoint": "Fibrosis improvement >=1 stage without MASH worsening at week 24/96",
      "biomarkers_used": ["BMK-001", "BMK-002", "BMK-006", "BMK-007", "BMK-041"],
      "korean_sites": 0,
      "status": "phase 3 enrolling (SYMMETRY)",
      "biomarker_data_summary": "Δ ELF -0.5 in EFX 50mg vs +0.1 placebo; Δ PRO-C3 -16% vs -2%"
    },
    {
      "trial_code": "SYMMETRY",
      "drug": "efruxifermin (FGF21 analog)",
      "sponsor": "Akero",
      "phase": "3",
      "n": 1200,
      "primary_endpoint": "Compensated MASH cirrhosis (F4) fibrosis reversal",
      "biomarkers_used": ["BMK-001", "BMK-007", "BMK-014", "BMK-018", "BMK-046"],
      "korean_sites": 3,
      "status": "enrolling 2025-2027",
      "biomarker_data_summary": "Pre-defined biomarker substudy: HepQuant SHUNT + spleen stiffness baseline n=300"
    },
    {
      "trial_code": "ENLIVEN",
      "drug": "pegozafermin (FGF21 analog)",
      "sponsor": "89bio",
      "phase": "2b",
      "n": 222,
      "primary_endpoint": "Fibrosis improvement and MASH resolution at week 24",
      "biomarkers_used": ["BMK-001", "BMK-006", "BMK-041", "BMK-019"],
      "korean_sites": 0,
      "status": "completed (positive), phase 3 ENLIGHTEN ongoing",
      "biomarker_data_summary": "MRI-PDFF >=30% reduction in 64% (44mg QW); ELF -0.4"
    },
    {
      "trial_code": "ENLIGHTEN",
      "drug": "pegozafermin (FGF21 analog)",
      "sponsor": "89bio",
      "phase": "3",
      "n": 1600,
      "primary_endpoint": "MASH resolution + fibrosis improvement at week 52",
      "biomarkers_used": ["BMK-006", "BMK-007", "BMK-001", "BMK-014"],
      "korean_sites": 4,
      "status": "enrolling 2025-2028",
      "biomarker_data_summary": "Composite NIT-based futility analysis at week 24"
    },
    {
      "trial_code": "SYNERGY-NASH",
      "drug": "tirzepatide (GIP/GLP-1)",
      "sponsor": "Lilly",
      "phase": "2",
      "n": 190,
      "primary_endpoint": "MASH resolution without fibrosis worsening at week 52",
      "biomarkers_used": ["BMK-001", "BMK-006", "BMK-014", "BMK-019", "BMK-042"],
      "korean_sites": 1,
      "status": "positive readout 2024",
      "biomarker_data_summary": "MASH resolution 62-74% across doses; adiponectin doubled"
    },
    {
      "trial_code": "LIVERAGE",
      "drug": "survodutide (GLP-1/glucagon)",
      "sponsor": "BI/Zealand",
      "phase": "2",
      "n": 295,
      "primary_endpoint": "Histologic MASH improvement at week 48",
      "biomarkers_used": ["BMK-006", "BMK-001", "BMK-002", "BMK-007"],
      "korean_sites": 1,
      "status": "positive readout 2024",
      "biomarker_data_summary": "MRI-PDFF reduction 60%; phase 3 LIVERAGE-3 launching"
    },
    {
      "trial_code": "NATIV3",
      "drug": "lanifibranor (pan-PPAR)",
      "sponsor": "Inventiva",
      "phase": "3",
      "n": 1000,
      "primary_endpoint": "MASH resolution and/or fibrosis improvement at week 72",
      "biomarkers_used": ["BMK-001", "BMK-006", "BMK-014", "BMK-042"],
      "korean_sites": 2,
      "status": "enrolling",
      "biomarker_data_summary": "Adiponectin Δ +120% expected as PD signal"
    },
    {
      "trial_code": "REVERSE",
      "drug": "obeticholic acid (FXR agonist) follow-up",
      "sponsor": "Intercept (Alfasigma)",
      "phase": "3 follow-up",
      "n": 919,
      "primary_endpoint": "Cirrhotic MASH safety + biomarker readouts",
      "biomarkers_used": ["BMK-001", "BMK-007", "BMK-018", "BMK-046"],
      "korean_sites": 0,
      "status": "long-term safety follow-up",
      "biomarker_data_summary": "Spleen stiffness + HepQuant SHUNT explored for portal hypertension trajectory"
    }
  ]
}