# MASHTrialPulse Daily Digest — 2026-04-26

> Disclaimer: 본 도구는 연구·교육 목적의 참고용이며, 임상시험 등록·MASH 처방·임상 의사결정 근거로 사용할 수 없습니다. 모든 데이터는 합성(synthetic)입니다.

## ClinicalTrials.gov diff (synthetic)

- **[pipeline]** retatrutide의 Eli Lilly이 2026-04-26에 Phase 2 신규 trial 등록을 보고함.
  - 영향 약물: retatrutide
  - id: NCT09000113
  - detail: 신규 trial 등록: Retatrutide TRIUMPH-MASH-Synth Phase 2 (synthetic) (Phase 2)
- **[pipeline]** VK2809의 Viking이 2026-04-26에 Phase 2b 신규 trial 등록을 보고함.
  - 영향 약물: VK2809
  - id: NCT09000114
  - detail: 신규 trial 등록: VK2809 VOYAGE-Synth MASH F2-F3 (synthetic) (Phase 2b)
- **[efficacy, regulatory]** semaglutide-2.4의 Novo Nordisk이 2026-04-26에 status Active, not recruiting -> Completed 변경을 보고함.
  - 영향 약물: semaglutide-2.4
  - id: NCT09000111
  - detail: semaglutide-2.4 status 변경: Active, not recruiting -> Completed
- **[efficacy, regulatory]** semaglutide-2.4의 Novo Nordisk이 2026-04-26에 결과(results posted)를 등록함.
  - 영향 약물: semaglutide-2.4
  - id: NCT09000111
  - detail: semaglutide-2.4 results posted (이전 False -> 현재 True)
- **[efficacy]** pemvidutide의 Altimmune이 2026-04-26에 status Active, not recruiting -> Completed 변경을 보고함.
  - 영향 약물: pemvidutide
  - id: NCT09000105
  - detail: pemvidutide status 변경: Active, not recruiting -> Completed
- **[efficacy]** pemvidutide의 Altimmune이 2026-04-26에 결과(results posted)를 등록함.
  - 영향 약물: pemvidutide
  - id: NCT09000105
  - detail: pemvidutide results posted (이전 False -> 현재 True)
- **[safety]** pemvidutide의 Altimmune trial에서 2026-04-26에 신규 AE term(transient lipase elevation)이 보고됨.
  - 영향 약물: pemvidutide
  - id: NCT09000105
  - detail: 새 AE term 추가: transient lipase elevation
- **[pipeline]** efruxifermin의 Akero이 2026-04-26에 phase Phase 2b -> Phase 3 전환을 보고함.
  - 영향 약물: efruxifermin
  - id: NCT09000102
  - detail: efruxifermin phase 변경: Phase 2b -> Phase 3
- **[pipeline]** efruxifermin의 Akero이 2026-04-26에 status Active, not recruiting -> Recruiting 변경을 보고함.
  - 영향 약물: efruxifermin
  - id: NCT09000102
  - detail: efruxifermin status 변경: Active, not recruiting -> Recruiting
- **[efficacy]** efruxifermin의 Akero이 2026-04-26에 primary completion 일정을 2026-09 -> 2027-09로 변경함.
  - 영향 약물: efruxifermin
  - id: NCT09000102
  - detail: efruxifermin primary completion 변경: 2026-09 -> 2027-09
- **[safety]** efruxifermin의 Akero trial에서 2026-04-26에 신규 AE term(transient ALT elevation)이 보고됨.
  - 영향 약물: efruxifermin
  - id: NCT09000102
  - detail: 새 AE term 추가: transient ALT elevation
- **[efficacy]** aldafermin의 NGM Bio이 2026-04-26에 결과(results posted)를 등록함.
  - 영향 약물: aldafermin
  - id: NCT09000108
  - detail: aldafermin results posted (이전 False -> 현재 True)
- **[pipeline]** survodutide의 Boehringer이 2026-04-26에 phase Phase 2 -> Phase 3 전환을 보고함.
  - 영향 약물: survodutide
  - id: NCT09000104
  - detail: survodutide phase 변경: Phase 2 -> Phase 3
- **[efficacy]** survodutide의 Boehringer이 2026-04-26에 primary completion 일정을 2026-11 -> 2027-11로 변경함.
  - 영향 약물: survodutide
  - id: NCT09000104
  - detail: survodutide primary completion 변경: 2026-11 -> 2027-11

## FDA news diff (synthetic)

- **[regulatory]** resmetirom에 대해 2026-04-26에 FDA regulatory 항목이 게시됨: Synthetic accelerated approval converted to traditional approval for THR-beta agent (synthetic).
  - 영향 약물: resmetirom
  - id: FDA-SYN-2026-0414
  - detail: 신규 FDA 항목: Synthetic accelerated approval converted to traditional approval for THR-beta agent (synthetic)
- **[safety, regulatory]** denifanstat에 대해 2026-04-26에 FDA safety 항목이 게시됨: Safety signal review opened for an investigational FASN inhibitor (synthetic).
  - 영향 약물: denifanstat
  - id: FDA-SYN-2026-0415
  - detail: 신규 FDA 항목: Safety signal review opened for an investigational FASN inhibitor (synthetic)

## EMA EPAR (synthetic)

- **[regulatory]** resmetirom에 대해 2026-04-26에 EMA regulatory 항목이 게시됨: CHMP positive opinion for synthetic THR-beta agonist in MASH (synthetic).
  - 영향 약물: resmetirom
  - id: EMA-SYN-2026-0078
  - detail: EMA: CHMP positive opinion for synthetic THR-beta agonist in MASH (synthetic)
- **[safety, regulatory]** semaglutide-2.4, liraglutide, tirzepatide에 대해 2026-04-25에 EMA safety 항목이 게시됨: PRAC review of GLP-1 class hepatic safety signals (synthetic).
  - 영향 약물: semaglutide-2.4, liraglutide, tirzepatide
  - id: EMA-SYN-2026-0079
  - detail: EMA: PRAC review of GLP-1 class hepatic safety signals (synthetic)

## PMDA news (synthetic)

- **[regulatory]** survodutide에 대해 2026-04-26에 PMDA regulatory 항목이 게시됨: PMDA grants Sakigake-equivalent designation for synthetic GCG/GLP-1 dual agonist (synthetic).
  - 영향 약물: survodutide
  - id: PMDA-SYN-2026-0033
  - detail: PMDA: PMDA grants Sakigake-equivalent designation for synthetic GCG/GLP-1 dual agonist (synthetic)

## Sponsor IR / SEC 8-K (synthetic)

- **[efficacy, pipeline]** Madrigal이 2026-04-26에 IR/8-K 공시: Synthetic Q1 update: real-world synthetic MASH cohort interim data (synthetic) (resmetirom).
  - 영향 약물: resmetirom
  - id: IR-MDGL-SYN-2026-04-26-01
  - detail: Madrigal 8-K: Synthetic Q1 update: real-world synthetic MASH cohort interim data (synthetic)
- **[efficacy]** Akero이 2026-04-26에 IR/PR 공시: Akero announces synthetic 96-week histology readout planning (synthetic) (efruxifermin).
  - 영향 약물: efruxifermin
  - id: IR-AKRO-SYN-2026-04-26-02
  - detail: Akero PR: Akero announces synthetic 96-week histology readout planning (synthetic)
- **[pipeline]** 89bio이 2026-04-26에 IR/8-K 공시: 89bio synthetic ENLIGHTEN-Synth enrollment milestone (synthetic) (pegozafermin).
  - 영향 약물: pegozafermin
  - id: IR-ETNB-SYN-2026-04-26-03
  - detail: 89bio 8-K: 89bio synthetic ENLIGHTEN-Synth enrollment milestone (synthetic)
- **[safety, efficacy]** Altimmune이 2026-04-26에 IR/PR 공시: Altimmune synthetic IMPACT-Synth topline summary released (synthetic) (pemvidutide).
  - 영향 약물: pemvidutide
  - id: IR-ALT-SYN-2026-04-26-04
  - detail: Altimmune PR: Altimmune synthetic IMPACT-Synth topline summary released (synthetic)
- **[safety]** Inventiva이 2026-04-26에 IR/PR 공시: Inventiva synthetic NATIV3-Synth DSMB safety review reaffirms continuation (synthetic) (lanifibranor).
  - 영향 약물: lanifibranor
  - id: IR-IVA-SYN-2026-04-26-05
  - detail: Inventiva PR: Inventiva synthetic NATIV3-Synth DSMB safety review reaffirms continuation (synthetic)

## AASLD The Liver Meeting 2026 abstracts (synthetic)

- **[efficacy]** AASLD 2026(synthetic) abstract: resmetirom - Long-term resmetirom exposure and synthetic real-world fibrosis regression (synthetic).
  - 영향 약물: resmetirom
  - id: AASLD-SYN-2026-001
  - detail: AASLD abstract (efficacy): Long-term resmetirom exposure and synthetic real-world fibrosis regression (synthetic)
- **[efficacy]** AASLD 2026(synthetic) abstract: efruxifermin - Efruxifermin synthetic 96-week histology readout (synthetic).
  - 영향 약물: efruxifermin
  - id: AASLD-SYN-2026-002
  - detail: AASLD abstract (efficacy): Efruxifermin synthetic 96-week histology readout (synthetic)
- **[efficacy]** AASLD 2026(synthetic) abstract: pemvidutide - Pemvidutide synthetic IMPACT-Synth topline (synthetic).
  - 영향 약물: pemvidutide
  - id: AASLD-SYN-2026-003
  - detail: AASLD abstract (efficacy): Pemvidutide synthetic IMPACT-Synth topline (synthetic)
- **[efficacy]** AASLD 2026(synthetic) abstract: survodutide - Survodutide MASH synthetic dose-response (synthetic).
  - 영향 약물: survodutide
  - id: AASLD-SYN-2026-004
  - detail: AASLD abstract (efficacy): Survodutide MASH synthetic dose-response (synthetic)
- **[safety, efficacy]** AASLD 2026(synthetic) abstract: pegozafermin - Pegozafermin F4 synthetic interim safety (synthetic).
  - 영향 약물: pegozafermin
  - id: AASLD-SYN-2026-005
  - detail: AASLD abstract (safety): Pegozafermin F4 synthetic interim safety (synthetic)
- **[safety]** AASLD 2026(synthetic) abstract: lanifibranor - Lanifibranor synthetic NATIV3-Synth DSMB update (synthetic).
  - 영향 약물: lanifibranor
  - id: AASLD-SYN-2026-006
  - detail: AASLD abstract (safety): Lanifibranor synthetic NATIV3-Synth DSMB update (synthetic)
- **[safety]** AASLD 2026(synthetic) abstract: denifanstat - Denifanstat synthetic alopecia adjudication (synthetic).
  - 영향 약물: denifanstat
  - id: AASLD-SYN-2026-007
  - detail: AASLD abstract (safety): Denifanstat synthetic alopecia adjudication (synthetic)

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### 출처 (sources, all synthetic)

- ClinicalTrials.gov API v2 (synthetic snapshot)
- FDA NewsRoom (synthetic)
- EMA EPAR (synthetic)
- PMDA news (synthetic)
- Sponsor IR pages + SEC EDGAR 8-K (synthetic)
- AASLD The Liver Meeting 2026 abstracts (synthetic)