预约演示
更新于：2026-03-11
Pegozafermin
更新于：2026-03-11
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床申请 |
特殊审评突破性疗法 (美国)、优先药物（PRIME） (欧盟) |
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结构/序列
Sequence Code 431553327
来源: *****
关联
7
项与 Pegozafermin 相关的临床试验NCT06419374
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
NCT06318169
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NCT05852431
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG): The ENTRUST Study
100 项与 Pegozafermin 相关的临床结果
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100 项与 Pegozafermin 相关的转化医学
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100 项与 Pegozafermin 相关的专利（医药）
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19
项与 Pegozafermin 相关的文献（医药）2026-02-01Clinical Gastroenterology and Hepatology
Clinical Utility of a 50% and 30% Decline in Magnetic Resonance Imaging-Proton Density Fat Fraction in Predicting Fibrosis Improvement in Metabolic Dysfunction-associated Steatohepatitis
Article
作者: Loomba, Rohit ; Huang, Daniel Q ; Wang, Youxin ; Siddiqi, Harris ; Madamba, Egbert ; Gottwald, Mildred D ; Margalit, Maya ; Feng, Shibao ; Bettencourt, Ricki ; Richards, Lisa ; Daniel, Peter Chen-Yang Nikhil
BACKGROUND & AIMS:
Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) response (≥30% relative decline in liver fat content on MRI-PDFF) can help to detect resolution of metabolic dysfunction-associated steatohepatitis (MASH) resolution, but there are limited data on whether it can reliably predict fibrosis improvement. We examined the association between MRI-PDFF super response (≥50% relative decline in liver fat content on MRI-PDFF) and fibrosis regression in a randomized placebo-controlled trial.
METHODS:
This is a secondary analysis of a large, multi-center, randomized, placebo-controlled trial that included 163 participants (64% female) with biopsy-confirmed MASH with stage 2 or 3 fibrosis who were treated for 24 weeks with pegozafermin or placebo and underwent contemporaneous laboratory testing, MRI-PDFF, and liver biopsy at 2 time points. The co-primary outcomes were fibrosis improvement without worsening of MASH and MASH resolution with no worsening of fibrosis.
RESULTS:
The median age and body mass index (BMI) of participants were 56.0 years (interquartile range, 48.0-62.0 years) and 36.5 kg/m2 (interquartile range, 32.2-40.2 kg/m2). The proportion of patients who achieved super-response was significantly higher in participants treated with pegozafermin (pooled 15 mg, 30 mg, and 44 mg arms) vs placebo (57.8% vs 11.1%; P < .0001). After multivariable adjustment for age, sex, BMI, race/ethnicity, and type 2 diabetes, MRI-PDFF super-response (adjusted odds ratio, 3.08; 95% confidence interval, 1.32-7.19; P = .009) remained an independent predictor of fibrosis regression without worsening MASH, but not MRI-PDFF response (adjusted odds ratio, 2.10; 95% confidence interval, 0.85-5.16; P = .11). Both MRI-PDFF response (P = .004) and MRI-PDFF super response (P < .001) were significant predictors of MASH resolution without worsening fibrosis.
CONCLUSIONS:
MRI-PDFF super response predicts fibrosis regression without worsening MASH, and a greater likelihood of MASH resolution without worsening fibrosis than MRI-PDFF response.
2026-01-01HEPATOLOGY
Comparative efficacy of pharmacologic therapies for MASH in reducing liver fat content: Systematic review and network meta-analysis
Review
作者: Nah, Benjamin ; Seko, Yuya ; Ramadoss, Vijay ; Takahashi, Hirokazu ; Noureddin, Mazen ; Ng, Cheng Han ; Xiao, Jieling ; Nakajima, Atsushi ; Koh, Benjamin ; Sim, Benedix Kuan Loon ; Teng, Margaret ; Huang, Daniel Q. ; Danpanichkul, Pojsakorn ; Teo, Chong Boon ; Gunalan, Shyna Zhuoying ; Law, Michelle ; Lim, Mei Chin ; Muthiah, Mark ; Wijarnpreecha, Karn ; Tan, En Ying ; Loomba, Rohit
Background and Aims::
Metabolic dysfunction–associated steatohepatitis (MASH) is a leading cause of liver disease. Dynamic changes in MRI proton-density-fat fraction (PDFF) are associated with MASH resolution. We aimed to determine the relative efficacy of therapeutic agents for reducing hepatic fat, assessed by MRI-PDFF.
Approach and Results::
In this systematic review and network meta-analysis, we searched MEDLINE and Embase from inception until December 26, 2023, for published randomized controlled trials comparing pharmacological interventions in patients with MASH that assessed changes in MRI-PDFF. The
primary outcome
was the absolute change in MRI-PDFF. The secondary outcome was a ≥30% decline in MRI-PDFF. A surface under-the-curve cumulative ranking probabilities (SUCRA) analysis was performed. Of 1550 records, a total of 39 randomized controlled trials (3311 participants) met the inclusion criteria. For MRI-PDFF decline at 24 weeks, aldafermin (SUCRA: 83.65), pegozafermin (SUCRA: 83.46), and pioglitazone (SUCRA: 71.67) were ranked the most effective interventions. At 24 weeks, efinopegdutide (SUCRA: 67.02), semaglutide + firsocostat (SUCRA: 62.43), and pegbelfermin (SUCRA: 61.68) were ranked the most effective interventions for achieving a ≥30% decline in MRI-PDFF.
Conclusions::
This study provides an updated, relative rank-order efficacy of therapies for MASH in reducing hepatic fat. These data may help inform the design and sample size calculation of future clinical trials and assist in the selection of combination therapy.
2026-01-01JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
Efficacy and safety of fibroblast growth factor 21 analogs in metabolic dysfunction–associated steatotic liver disease and metabolic dysfunction–associated steatohepatitis: A systematic review and network meta-analysis
Review
作者: Abouelmagd, Khaled ; Taha, Nouran A ; Fareed, Areeba ; Keshk, Menna ; Taha, Amira Mohamed ; Ali, Shujaat ; Hasan, Mohammed Tarek ; Khan, Misha ; Abdelkader Saed, Sara Adel ; Abdeljawad, Marwa Muhammed
Metabolic dysfunction-associated steatotic liver disease has emerged as a global public health concern. Fibroblast growth factor 21, a liver hormone, is gaining interest because of its ability to regulate metabolism and improve metabolic dysfunction-associated steatotic liver disease. In this network meta-analysis, we investigated the efficacy of these treatments in treating metabolic dysfunction-associated steatotic liver disease. A comprehensive search was conducted across electronic databases, including PubMed, Scopus, the Cochrane Library, and Web of Science, till August 2025. We used R software to analyze data using a random effects model. Heatmaps were used to visualize the included interventions' ranking. We included 9 clinical trials comprising 1277 patients. Among them, 284 received efruxifermin, 263 received pegbelfermin, 151 received pegozafermin, 65 received efimosfermin, 139 received MK-3655, and 375 received a placebo. Pegozafermin and efruxifermin were effective in improving liver fibrosis (RR, 3.89-3.93, P < .05; RR, 2.23-1.91, P < .05, respectively), whereas the other interventions did not yield statistical significance. Efimosfermin α, efruxifermin, and pegozafermin improved different metabolic parameters, including adiponectin, hemoglobin A1c, and non-high-density lipoprotein. However, no significant differences were observed in body weight and low-density lipoprotein. For liver enzymes, efimosfermin α had the greatest reduction of alanine aminotransferase and aspartate aminotransferase, whereas efruxifermin was most effective in reducing γ-glutamyl transferase levels. The odds of adverse events were higher in pegozafermin, efimosfermin, and efruxifermin groups, mainly attributed to mild to moderate gastrointestinal adverse events. In conclusion, efruxifermin and pegozafermin are promising therapeutic options with a tolerable adverse event profile; meanwhile, efimosfermin α showed promising results in improving metabolic parameters, with histologic results yet to be published. SIGNIFICANCE STATEMENT: This meta-analysis evaluates the efficacy of fibroblast growth factor 21 analogs in improving metabolic dysfunction-associated steatotic liver disease. Efruxifermin and pegozafermin were the most significant in improving liver fibrosis; moreover; significant improvements in some metabolic parameters were observed with efimosfermin α, efruxifermin, and pegozafermin.
100 项与 Pegozafermin 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 慢性肝病 | 临床3期 | 美国 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 阿根廷 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 澳大利亚 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 比利时 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 巴西 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 保加利亚 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 加拿大 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 法国 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 德国 | 2024-10-30 | |
| 慢性肝病 | 临床3期 | 中国香港 | 2024-10-30 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 222 | (Main Study: Pegozafermin 15 mg QW) | 觸鹽齋願繭餘鏇願憲鬱 = 淵繭艱齋衊選糧獵觸鬱 鏇製範齋願憲選廠選鏇 (鑰簾醖鑰壓觸糧夢餘鬱, 醖襯夢鹽糧觸觸鹹願鑰 ~ 艱選範蓋窪範鹽膚淵艱) 更多 | - | 2026-01-06 | ||
(Main Study: Pegozafermin 30 mg QW) | 觸鹽齋願繭餘鏇願憲鬱 = 膚膚構獵膚鏇願築窪願 鏇製範齋願憲選廠選鏇 (鑰簾醖鑰壓觸糧夢餘鬱, 齋襯廠壓鹹選淵夢廠憲 ~ 觸糧選願鏇糧遞糧蓋範) 更多 | ||||||
临床2期 | 86 | Placebo (Placebo) | 觸鹽襯夢衊繭選艱願觸(廠製蓋淵窪範構夢鏇鏇) = 廠鬱築艱遞憲窪醖簾夢 鏇構壓顧膚膚蓋艱餘壓 (壓鹽鹽網繭壓獵鏇獵鹽, 遞範醖觸顧願壓鹹鑰衊 ~ 鏇網壓艱繭簾憲淵鏇襯) 更多 | - | 2024-07-25 | ||
(Pegozafermin 9 mg QW) | 簾淵窪壓壓鏇製範製廠(窪淵觸積顧鹹繭顧餘鬱) = 遞製網觸壓製積積繭憲 餘夢選網醖網壓膚鹽積 (簾膚鹹築夢鑰觸糧壓鏇, 齋醖衊簾鹽醖廠觸願廠 ~ 選膚餘夢鏇鏇鬱鏇鬱範) 更多 | ||||||
临床1/2期 | 101 | (Part 1: Pegozafermin 9 mg QW) | 願齋構簾夢鹽築網壓壓 = 憲醖繭蓋窪鏇艱艱壓鹹 積網鑰鏇齋鏇鏇淵蓋鹽 (鹽蓋艱壓衊廠鹹齋壓窪, 壓夢襯鹽膚憲鏇窪鹽範 ~ 窪鏇鏇範鏇繭艱鬱憲廠) 更多 | - | 2024-04-02 | ||
(Part 1: Pegozafermin 18 mg QW) | 願齋構簾夢鹽築網壓壓 = 襯製觸窪繭壓願顧製憲 積網鑰鏇齋鏇鏇淵蓋鹽 (鹽蓋艱壓衊廠鹹齋壓窪, 獵獵憲糧鹽衊襯繭製衊 ~ 壓襯鏇構築繭觸壓繭糧) 更多 | ||||||
临床2期 | - | pegofermin 30mg (纤维化阶段为F2-F3) | 膚衊積廠構壓艱襯憲艱(壓鹹淵繭遞夢顧夢齋膚) = 鹽鬱廠鬱艱鹹壓簾鹽構 鹽選衊夢窪夢積鏇鏇鑰 (餘觸淵艱鹹壓鑰艱廠簾 ) 更多 | 积极 | 2023-11-29 | ||
pegofermin 44 mg (纤维化阶段为F2-F3) | 膚衊積廠構壓艱襯憲艱(壓鹹淵繭遞夢顧夢齋膚) = 鑰淵膚顧網積觸襯鹽鑰 鹽選衊夢窪夢積鏇鏇鑰 (餘觸淵艱鹹壓鑰艱廠簾 ) 更多 | ||||||
临床2期 | 130 | 淵餘簾鏇蓋網艱鬱鬱獵(衊淵觸網構廠觸觸獵製) = 網窪範構繭鹽齋窪鏇範 襯簾觸衊製選憲網鑰網 (廠醖簾觸鏇觸鏇選鹹衊 ) 更多 | 积极 | 2023-11-27 | |||
淵餘簾鏇蓋網艱鬱鬱獵(衊淵觸網構廠觸觸獵製) = 糧衊構選醖構淵築衊壓 襯簾觸衊製選憲網鑰網 (廠醖簾觸鏇觸鏇選鹹衊 ) 更多 | |||||||
临床2期 | 13 | 餘齋繭築膚鏇窪襯簾獵(襯遞簾齋繭願遞憲鑰艱) = 範獵網鑰窪夢憲築顧積 鹽醖繭襯願簾簾艱鏇選 (衊鏇積憲製淵鹽鏇窪膚 ) 更多 | 积极 | 2023-11-12 | |||
Placebo | 餘齋繭築膚鏇窪襯簾獵(襯遞簾齋繭願遞憲鑰艱) = 襯製簾壓憲構糧夢衊鹽 鹽醖繭襯願簾簾艱鏇選 (衊鏇積憲製淵鹽鏇窪膚 ) 更多 | ||||||
临床2期 | 14 | 鏇範醖遞艱窪遞網齋襯(鹹簾顧鏇衊鑰醖夢糧顧) = 夢齋糧廠構憲壓醖鹽窪 觸艱網淵襯廠餘艱膚網 (範鬱淵壓構鹽蓋願膚顧 ) 更多 | 积极 | 2023-11-10 | |||
临床1/2期 | 20 | 夢鬱繭糧顧廠餘構構艱(衊糧範鑰蓋遞築網積繭) = mild/moderate diarrhoea reported in 90% of subjects 觸觸憲築艱壓衊淵淵淵 (選選遞簾繭蓋憲鏇糧築 ) 更多 | 积极 | 2023-11-01 | |||
临床2期 | 222 | 繭餘鬱蓋廠築選鑰窪壓(構鏇窪鹽願窪鹽製襯遞) = 遞鑰觸壓繭襯構範鏇網 願顧餘製窪遞齋製願鬱 (製築獵鏇範鹹遞構蓋鏇 ) 更多 | 积极 | 2023-06-24 | |||
繭餘鬱蓋廠築選鑰窪壓(構鏇窪鹽願窪鹽製襯遞) = 製範繭遞憲鏇鏇糧鏇選 願顧餘製窪遞齋製願鬱 (製築獵鏇範鹹遞構蓋鏇 ) 更多 | |||||||
临床1/2期 | 20 | 糧鬱築觸鬱鑰餘觸餘衊(齋廠構醖衊獵廠衊選積) = BW decreased by -3.9% (p < 0.001) 積窪顧遞遞簾襯鏇築衊 (網夢鬱蓋繭簾艱簾觸繭 ) 更多 | 积极 | 2023-01-05 |
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