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"name": "KOREA-CKD-AOMcoach-DTx", "sponsor": "Chong Kun Dang + Welt", "country": "Korea", "drug_class": "digital therapeutic + GLP-1RA", "intervention": "DTx coaching app + liraglutide", "condition": "obesity", "phase": "Phase 3", "status": "Recruiting", "first_posted": "2024-05-30", "primary_completion": "2026-05-31", "readout_estimated": "2026-08-31", "current_n": 280, "korean_site": true, "amendments": [ {"date": "2024-12-22", "type": "primary_endpoint", "before": "% weight change @ 52wk", "after": "% weight change @ 52wk (DTx engagement-adjusted)", "reason": "PMDA-style DTx adjustment", "note": "DTx 보정"}, {"date": "2025-07-08", "type": "exclusion", "before": "no smartphone proficiency required", "after": "smartphone proficiency required (Android/iOS)", "reason": "DTx feasibility", "note": "exclusion 강화"} ] }, { "trial_id": "CRIS-KCT0008900", "registry": "CRIS-Korea", "name": "KOREA-SARCOPENIC-OB", "sponsor": "Severance + Yuhan", "country": "Korea", "drug_class": "GLP-1RA + 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26wk", "reason": "timepoint align with reimbursement", "note": "★★ primary 시점 변경"}, {"date": "2025-04-15", "type": "secondary_endpoint", "before": "PHQ-9", "after": "PHQ-9 + EQ-5D-5L", "reason": "HRQoL add", "note": "secondary 확장"} ] }, { "trial_id": "ACTRN12625000033399", "registry": "ANZCTR", "name": "ANZ-RETA-OB", "sponsor": "Eli Lilly Australia", "country": "Australia", "drug_class": "triple agonist", "intervention": "retatrutide", "condition": "obesity", "phase": "Phase 2b", "status": "Recruiting", "first_posted": "2025-01-08", "primary_completion": "2026-12-31", "readout_estimated": "2027-03-31", "current_n": 260, "korean_site": false, "amendments": [ {"date": "2025-06-20", "type": "exclusion", "before": "no severe AE history", "after": "no severe AE history + no active malignancy 5y", "reason": "safety", "note": "exclusion 강화"} ] }, { "trial_id": "NCT05844111", "registry": "ClinicalTrials.gov", "name": "SURPASS-OB-PEDS", "sponsor": "Eli Lilly", "country": "US", "drug_class": "GIP/GLP-1 dual", "intervention": "tirzepatide (pediatric)", "condition": "pediatric obesity (10-17y)", "phase": "Phase 3", "status": "Recruiting", "first_posted": "2023-05-10", "primary_completion": "2026-04-30", "readout_estimated": "2026-08-31", "current_n": 720, "korean_site": false, "amendments": [ {"date": "2024-07-15", "type": "exclusion", "before": "no eating disorder history", "after": "no eating disorder history + assent required", "reason": "ethics", "note": "exclusion 추가"}, {"date": "2025-02-08", "type": "primary_endpoint", "before": "BMI %ile change", "after": "BMI Z-score change", "reason": "pediatric standard", "note": "★★★ primary 정의 변경"} ] }, { "trial_id": "NCT05990001", "registry": "ClinicalTrials.gov", "name": "MARITIDE-2", "sponsor": "Amgen", "country": "US/Global", "drug_class": "amylin/GLP-1", "intervention": "MariTide (AMG133)", "condition": "obesity", "phase": "Phase 3", "status": "Recruiting", "first_posted": "2024-04-22", "primary_completion": "2026-10-31", "readout_estimated": "2027-02-28", "current_n": 3300, "korean_site": true, "amendments": [ {"date": "2025-01-18", "type": "primary_endpoint", "before": "% weight loss @ 52wk", "after": "% weight loss @ 72wk", "reason": "plateau time", "note": "★★ 시점 연장"}, {"date": "2025-09-30", "type": "sample_size", "before": 3000, "after": 3300, "reason": "additional dose arm", "note": "+10%"} ] }, { "trial_id": "NCT06234567", "registry": "ClinicalTrials.gov", "name": "ECLIPSE-OB-DEVICE", "sponsor": "Boston Scientific", "country": "US", "drug_class": "endoscopic device", "intervention": "intragastric balloon (next-gen)", "condition": "obesity (BMI 30-40)", "phase": "N/A", "status": "Withdrawn", "first_posted": "2024-02-02", "primary_completion": "2025-08-31", "readout_estimated": null, "current_n": 0, "korean_site": false, "amendments": [ {"date": "2024-12-05", "type": "status", "before": "Not yet recruiting", "after": "Withdrawn", "reason": "business decision (funding)", "note": "★★★ withdrawal funding 사유"} ] }, { "trial_id": "NCT05789011", "registry": "ClinicalTrials.gov", "name": "OPTIWIN-2", "sponsor": "Currax Pharmaceuticals", "country": "US", "drug_class": "naltrexone/bupropion", "intervention": "Contrave", "condition": "obesity", "phase": "Phase 4", "status": "Active, not recruiting", "first_posted": "2023-03-08", "primary_completion": "2025-03-31", "readout_estimated": "2025-06-30", "current_n": 990, "korean_site": false, "amendments": [ {"date": "2024-05-17", "type": "secondary_endpoint", "before": "cravings VAS", "after": "cravings VAS + food addiction (YFAS)", "reason": "exploratory", "note": "secondary 확장"} ] }, { "trial_id": "NCT06330011", "registry": "ClinicalTrials.gov", "name": "GLOW-MASLD-OB", "sponsor": "Madrigal", "country": "US/EU", "drug_class": "THR-β agonist", "intervention": "resmetirom", "condition": "obesity + MASH (F2-F3)", "phase": "Phase 3b", "status": "Recruiting", "first_posted": "2024-06-11", "primary_completion": "2027-03-31", "readout_estimated": "2027-06-30", "current_n": 800, "korean_site": false, "amendments": [ {"date": "2025-03-04", "type": "secondary_endpoint", "before": "weight %", "after": "weight % + waist circumference", "reason": "obesity focus", "note": "secondary 확장"}, {"date": "2025-09-19", "type": "exclusion", "before": "Child-Pugh A", "after": "Child-Pugh A (B 일부 허용)", "reason": "expand pop", "note": "exclusion 완화"} ] }, { "trial_id": "NCT06401122", "registry": "ClinicalTrials.gov", "name": "PALOMA-OB-COMBO", "sponsor": "Roche", "country": "Global", "drug_class": "amylin + GLP-1RA combo", "intervention": "petrelintide + semaglutide", "condition": "obesity", "phase": "Phase 2", "status": "Recruiting", "first_posted": "2024-08-19", "primary_completion": "2026-06-30", "readout_estimated": "2026-09-30", "current_n": 520, "korean_site": false, "amendments": [ {"date": "2025-04-25", "type": "comparator", "before": "placebo + semaglutide", "after": "placebo + semaglutide + tirzepatide active reference arm", "reason": "head-to-head", "note": "★★★ comparator 변경"} ] }, { "trial_id": "NCT06222233", "registry": "ClinicalTrials.gov", "name": "EVOKE-OB-AD", "sponsor": "Novo Nordisk", "country": "Global", "drug_class": "GLP-1RA", "intervention": "semaglutide", "condition": "obesity + early AD", "phase": "Phase 3", "status": "Active, not recruiting", "first_posted": "2024-01-30", "primary_completion": "2025-09-30", "readout_estimated": "2025-12-31", "current_n": 1840, "korean_site": false, "amendments": [ {"date": "2024-11-12", "type": "secondary_endpoint", "before": "CDR-SB", "after": "CDR-SB + plasma p-tau217", "reason": "biomarker add", "note": "secondary 확장"}, {"date": "2025-06-30", "type": "analysis_plan", "before": "MMRM", "after": "MMRM + Bayesian sensitivity", "reason": "post-hoc", "note": "post-hoc 추가"} ] } ]