预约演示
更新于：2026-08-27
Efimosfermin alfa
更新于：2026-08-27
概要
基本信息
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3期 |
特殊审评优先药物（PRIME） (欧盟)、突破性疗法 (中国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 127087
来源: *****
关联
11
项与 Efimosfermin alfa 相关的临床试验JPRN-jRCT2041260085
A Phase 3, two-part, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of efimosfermin alfa injection in adult
participants with compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (NEBULA-2)
JPRN-jRCT2041260084
A Phase 3, double-blind, randomized, placebo controlled, 2-arm study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (NEBULA-1)
NCT07701993
A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)
100 项与 Efimosfermin alfa 相关的临床结果
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100 项与 Efimosfermin alfa 相关的转化医学
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100 项与 Efimosfermin alfa 相关的专利（医药）
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5
项与 Efimosfermin alfa 相关的文献（医药）2026-02-01LANCET
Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial
Article
作者: Kowdley, Kris V ; Zhao, Jeff ; Odrljin, Tatjana ; Jeglinski, Brenda ; Bain, Gerard ; Loomba, Rohit ; Noureddin, Mazen ; Koziel, Margaret James
BACKGROUND:
The growing prevalence of metabolic dysfunction-associated steatohepatitis (MASH) underscores the unmet need for effective and safe liver-targeted therapies to prevent fibrosis and disease progression. The aim of this study was to evaluate the efficacy and safety of efimosfermin alfa (henceforth referred to as efimosfermin, formerly BOS-580), an FGF21 analogue taken once per month, in patients with MASH and moderate or advanced fibrosis.
METHODS:
This 24-week, randomised, double-blind, placebo-controlled, phase 2 trial evaluated the safety and efficacy of efimosfermin in participants aged 18-75 years with a BMI of at least 27 kg/m2 and MASH and F2 or F3 fibrosis present on a diagnostic liver biopsy done either during screening or within 6 months before the first day of dosing, and total activity Nonalcoholic Fatty Liver Disease Activity Score (NAS) of at least 4 with a minimum score of 1 point for all three NAS components (steatosis, hepatocyte ballooning, and lobular inflammation). The trial was conducted at 34 clinical research study sites in the USA. Participants were randomly assigned 1:1 to efimosfermin 300 mg or placebo administered by subcutaneous injection every 4 weeks (Q4W) over 24 weeks, stratified by MASH fibrosis stage (F2 vs F3 stage). Participants, investigators, and those assessing outcomes were masked to group assignment. The primary endpoint was safety and tolerability (ie, treatment-emergent adverse events, changes from baseline to week 24 in blood pressure and heart rate, and the incidence of grade 3 and grade 4 laboratory abnormalities at week 24), analysed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov (NCT04880031) and was completed on Sept 18, 2024.
FINDINGS:
Between May 4, 2023, and March 22, 2024, of 1171 participants screened, 84 participants were randomly assigned to efimosfermin 300 mg Q4W (n=43) or placebo (n=41); 44 (52%) were female and 40 (48%) were male. 48 (57%) had F2 fibrosis and 36 (43%) had F3 fibrosis; 65 had evaluable week-24 biopsy results. All 43 in the efimosfermin group and 40 of 41 participants in the placebo group received at least one dose. Adverse events were reported in 29 (67%) of 43 participants receiving efimosfermin and 22 (55%) of 40 receiving placebo. The majority of treatment-emergent adverse events were mild (24 [56%] of 43 in the efimosfermin group vs 15 [38%] of 40 in the placebo group) or moderate (18 [42%] vs 14 [35%]) in severity. Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. There were no clinically meaningful changes in vital signs between treatment and placebo groups, and no clinically significant grade 3 or higher laboratory abnormalities observed for either group. No deaths or adverse events greater than grade 3 were observed during the study.
INTERPRETATION:
In this phase 2 trial, treatment with efimosfermin once per month was generally well tolerated in participants with biopsy-confirmed MASH and F2 or F3 fibrosis. These results support the further development of efimosfermin for treatment of MASH-related fibrosis.
FUNDING:
Boston Pharmaceuticals and GSK.
2025-12-01Gastroenterology & hepatology
Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH With F2/F3 Fibrosis: Results From a Phase 2, Open-Label Extension Study.
Article
2025-08-01The Lancet Gastroenterology & Hepatology
Efimosfermin alfa (BOS-580), a long-acting FGF21 analogue, in participants with phenotypic metabolic dysfunction-associated steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial
Article
作者: Loomba, Rohit ; Morrow, Linda ; Clawson, Alicia ; Odrljin, Tatjana ; Kowdley, Kris V ; Alvarez, Alina Maria ; Bain, Gerard ; Chowdhury, Swapan ; Jeglinski, Brenda ; Kim, Nomita J ; Rodriguez, Jose
BACKGROUND:
Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive disease characterised by steatosis, inflammation, and liver fibrosis. Efimosfermin alfa (efimosfermin, formerly BOS-580) is a long-acting, engineered variant of FGF21 designed to have a prolonged half-life. We aimed to assess the safety and tolerability of multiple efimosfermin doses and dosing regimens compared with placebo and to evaluate exploratory biomarkers of efficacy in participants with phenotypic MASH.
METHODS:
This multicentre, randomised, double-blind, placebo-controlled, phase 2a trial was conducted at 12 centres in the USA. Individuals with phenotypic MASH, aged 18-75 years and with a BMI of 30-45 kg/m2, were eligible for the study. Participants were randomly assigned, using a centralised interactive randomisation system with no stratification factors, to one of five dosing cohorts: efimosfermin 75 mg once every 4 weeks, 75 mg once every 2 weeks, 150 mg once every 4 weeks, 150 mg once every 2 weeks, or 300 mg once every 4 weeks, for a 12-week treatment period. Participants were assigned 1:1:1:1 to all cohorts except efimosfermin 150 mg once every 4 weeks, which was initiated after assignment to the other cohorts was complete. Within each cohort, participants were randomly assigned 4:1 to receive efimosfermin or placebo, via subcutaneous injection, in fixed blocks of size five. Investigators and participants were masked to group assignment and treatment allocation. The primary endpoint was safety and tolerability and was assessed throughout the 12-week treatment period and at the follow-up visit 4 weeks after the final dose in the full analysis set, defined as enrolled participants who received at least one dose of study medication. Part A (reported here) of this phase 2 study is complete, while other parts of the phase 2 study are ongoing. This trial is registered with ClinicalTrials.gov (NCT04880031).
FINDINGS:
Between Aug 27, 2021, and July 22, 2022, 360 individuals were screened, of whom 102 were eligible and were randomly assigned to receive placebo (n=37) or efimosfermin 75 mg every 4 weeks (n=8), 75 mg every 2 weeks (n=14), 150 mg every 4 weeks (n=15), 150 mg every 2 weeks (n=15), or 300 mg every 4 weeks (n=13), for a total of 12 weeks. 45 (44%) of the 102 participants were female and 57 (56%) were male, with a mean age of 53 years (SD 11) and mean BMI of 36·5 kg/m2 (SD 4·1). Of 65 participants treated with efimosfermin, 43 (66%) had treatment-emergent adverse events (TEAEs): four (50%) of eight participants receiving 75 mg every 4 weeks, ten (71%) of 14 participants receiving 75 mg every 2 weeks, six (40%) of 15 participants receiving 150 mg every 4 weeks; 12 (80%) of 15 participants receiving 150 mg every 2 weeks, and 11 (85%) of 13 participants receiving 300 mg every 4 weeks; TEAEs were recorded in 18 (49%) of 37 participants receiving placebo. TEAEs were typically mild-to-moderate in severity and resolved spontaneously. The most frequent TEAEs were gastrointestinal in nature, reported by nine (24%) of 37 participants in the placebo group and 26 (40%) of 65 participants who received efimosfermin: two (25%) of eight participants receiving 75 mg every 4 weeks, eight (57%) of 14 participants receiving 75 mg every 2 weeks, two (13%) of 15 participants receiving 150 mg every 4 weeks, eight (53%) of 15 participants receiving 150 mg every 2 weeks, and six (46%) of 13 participants receiving 300 mg every 4 weeks. The most common gastrointestinal events were nausea, vomiting, and diarrhoea. There were no treatment-related deaths. At week 12, 47 (89%) of 53 participants receiving efimosfermin for whom data were available had at least a 30% reduction in hepatic fat fraction: five (63%) of eight participants receiving 75 mg every 4 weeks, 11 (92%) of 12 participants receiving 75 mg every 2 weeks, nine (90%) of ten participants receiving 150 mg every 4 weeks, 11 (92%) of 12 participants receiving 150 mg every 2 weeks, and all 11 (100%) participants receiving 300 mg every 4 weeks, compared with two (7%) of 30 participants receiving placebo.
INTERPRETATION:
In participants with phenotypic MASH, efimosfermin had a favourable safety profile and showed improvements in indicators of hepatic steatosis. These results help to inform future studies of efimosfermin in this important disease state.
FUNDING:
Boston Pharmaceuticals.
103
项与 Efimosfermin alfa 相关的新闻（医药）2026-08-17
100 项与 Efimosfermin alfa 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肝纤维化 | 临床3期 | 美国 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 中国 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 日本 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 阿根廷 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 澳大利亚 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 奥地利 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 比利时 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 巴西 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 保加利亚 | 2026-08-14 | |
| 肝纤维化 | 临床3期 | 加拿大 | 2026-08-14 |
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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 | 120 | Efimosfermin 225 mg | 選觸蓋憲蓋廠範選觸憲(齋簾鹹憲鏇襯範構繭壓) = 願壓膚糧襯製鬱淵構餘 築蓋鹽顧壓鑰淵糧積積 (積網蓋膚壓遞觸淵鏇簾 ) 更多 | 积极 | 2026-05-27 | ||
Efimosfermin 300 mg | 選觸蓋憲蓋廠範選觸憲(齋簾鹹憲鏇襯範構繭壓) = 遞衊夢積齋構鏇簾構廠 築蓋鹽顧壓鑰淵糧積積 (積網蓋膚壓遞觸淵鏇簾 ) 更多 | ||||||
临床2期 | 84 | Efimosfermin 300 mg Q4W | 網壓廠積願簾醖蓋淵衊(簾窪願餘觸顧鑰夢範繭) = Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. 窪憲簾壓構醖鬱獵鬱鏇 (簾鑰鏇鹹夢糧蓋壓願製 ) | 积极 | 2026-02-01 | ||
Placebo | |||||||
临床2期 | 65 | 鑰遞餘艱製衊鏇鑰襯廠(選簾觸網選選鏇糧淵顧) = 窪鹹構衊憲構觸鏇獵獵 蓋築糧構鑰餘壓製構襯 (獵衊憲鬱網膚獵壓願鹹 ) 更多 | 积极 | 2025-08-01 | |||
(75 mg every 4 weeks) | 鑰遞餘艱製衊鏇鑰襯廠(選簾觸網選選鏇糧淵顧) = 糧觸構壓餘繭遞構構鑰 蓋築糧構鑰餘壓製構襯 (獵衊憲鬱網膚獵壓願鹹 ) 更多 | ||||||
临床2期 | 代谢功能障碍相关脂肪性肝炎 Fibroscan-AST (FAST) | Fibrosis-4 Index (FIB-4) | NAFLD Fibrosis Score (NFS) | 84 | Efimosfermin 300mg | 齋壓積顧繭膚顧廠淵憲(壓繭積網衊願膚選鑰範) = 齋鹽膚獵鏇簾鹽鹽艱齋 醖齋窪餘襯淵積繭鏇鬱 (簾構艱繭衊網齋壓觸蓋 ) 更多 | 积极 | 2025-05-03 | |
Placebo | 齋壓積顧繭膚顧廠淵憲(壓繭積網衊願膚選鑰範) = 窪窪鑰網衊廠顧壓網顧 醖齋窪餘襯淵積繭鏇鬱 (簾構艱繭衊網齋壓觸蓋 ) 更多 | ||||||
临床2期 | 84 | 積糧網遞壓膚齋觸餘築(鏇衊網鹽築壓遞選選觸) = 獵糧選蓋願願築齋製醖 網膚艱蓋襯繭範築齋鹹 (遞餘顧構憲製觸齋淵艱 ) 更多 | 积极 | 2024-11-15 | |||
Placebo | 積糧網遞壓膚齋觸餘築(鏇衊網鹽築壓遞選選觸) = 繭餘積夢築衊範獵鑰醖 網膚艱蓋襯繭範築齋鹹 (遞餘顧構憲製觸齋淵艱 ) 更多 | ||||||
临床2期 | - | 102 | 構夢艱齋衊糧衊觸網齋(積餘鹽淵窪憲繭壓廠膚) = 廠鏇夢衊齋襯鬱壓艱鹽 觸築獵齋餘選夢襯築獵 (築築鑰構獵觸艱構糧憲 ) | 积极 | 2024-01-04 | ||
Placebo | 構夢艱齋衊糧衊觸網齋(積餘鹽淵窪憲繭壓廠膚) = 製積簾積襯鏇衊獵鬱衊 觸築獵齋餘選夢襯築獵 (築築鑰構獵觸艱構糧憲 ) | ||||||
临床2期 | 102 | overall | 醖襯鹽觸鬱窪鹽夢顧製(衊獵鏇獵憲壓顧膚繭鹽) = No treatment emergent adverse events of hypoglycemia were reported in any patient enrolled in the study. 繭築淵積艱遞築鹽構廠 (窪獵鏇鏇構鏇淵鏇壓齋 ) 更多 | 积极 | 2023-11-10 | ||
(HbA1c≥6.5%) | |||||||
临床1期 | 64 | 淵壓簾選顧廠構鏇遞獵(餘醖選鹽餘繭積鹹鬱襯) = higher incidence of generally mild to moderate gastrointestinal adverse effects 願鬱醖遞顧鬱憲廠顧鏇 (壓醖選窪築顧淵淵鹽醖 ) | - | 2021-08-25 |
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