Trial reportAlimentary pharmacology & therapeutics2025
Clinical Trial: A Phase 2b Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-Cirrhotic MASH.
Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04583423 (A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
Who cites it
6 citing papers in PubMed.
- The liver in diabetes: current state and future perspectives.Diabetologia · 2026Review
- Hypothalamus-liver talks: whispers in the language of metabolism.Reviews in endocrine & metabolic disorders · 2026Review
- Current Drug Development Pipeline for MASLD and MASH: Focusing on Cardiovascular Comorbidities.Biomedicines · 2026Review
- FGF family in health and disease.Molecular biomedicine · 2026Review
- Pharmacological Treatment of MASLD: Contemporary Treatment and Future Perspectives.International journal of molecular sciences · 2025Review
- Targeting fibroblast growth factor (FGF)-21: a promising strategy for metabolic dysfunction-associated steatotic liver disease treatment.Frontiers in pharmacology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundFibroblast growth factor 21 (FGF21) is a metabolic regulator with demonstrated efficacy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). FGF21 signals through 'c' isoforms of the FGF receptors (FGFR) 1-3 and the co-receptor β-klotho.
aimsWe report the safety and efficacy of MK-3655, a monoclonal antibody that binds β-klotho and selectively activates the FGFR1c/β-klotho co-receptor complex, in patients with pre-cirrhotic MASH.
methodsPhase 2b, randomised, multicenter, double-blind, placebo-controlled, parallel-group study in patients with pre-cirrhotic MASH (NAS ≥ 4 and MASH CRN fibrosis score Stage 2 or 3). Participants were randomised 1:1:1:1 to receive MK-3655 50 mg, 100 mg, 300 mg, or matching placebo subcutaneously every 4 weeks. The primary endpoint was MASH resolution without worsening of fibrosis by histology at Week 52. An interim analysis (IA) of liver fat content (LFC) was planned once ≥ 25 participants per treatment group completed an MRI-PDFF assessment at Week 24.
resultsAmong 183 participants, mean BMI was 33.4 kg/m
conclusionsIn patients with pre-cirrhotic MASH, treatment with MK-3655 resulted in a modest reduction in LFC at 24 weeks. CLINICAL TRIAL NUMBER: EudraCT: 2019-003048-63; NCT: 04583423.
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