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)

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

开始日期2024-05-24

申办/合作机构

89bio, Inc.

NCT06318169

/ Recruiting临床3期

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis [NASH]).

开始日期2024-03-13

申办/合作机构

89bio, Inc.

CTIS2023-503576-25-00

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG) - BIO89-100-231

开始日期2023-10-13

申办/合作机构

89bio, Inc.

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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项与 Pegozafermin 相关的文献（医药）

2024-07-01·Clinical Pharmacology & Therapeutics

Efficacy and Safety of Fibroblast Growth Factor‐21 Analogs for the Treatment of Metabolic Dysfunction‐Associated Steatohepatitis: A Systematic Review and Meta‐Analysis

Review

作者: Jeon, Nakyung ; Baek, In‐hwan ; Han, Nayoung ; Jeong, Changhyeon ; Rhee, Su‐jin ; Kim, Min‐Soo ; Staatz, Christine E.

Fibroblast growth factor (FGF)‐21 analogs are potential therapeutic candidates for metabolic dysfunction‐associated steatohepatitis (MASH). This systematic review and meta‐analysis aimed to assess the efficacy and safety of the FGF‐21 analogs, efruxifermin, pegbelfermin, and pegozafermin for MASH treatment. A comprehensive systematic review and meta‐analysis of randomized controlled trials from five major databases was conducted. Primary efficacy outcomes focused on liver histological improvement, while secondary efficacy outcomes encompassed reductions in liver fat content and improvements in biochemical parameters. Safety outcomes examined included treatment‐emergent adverse events (TEAEs), treatment‐related TEAEs, TEAEs leading to discontinuation, and serious TEAEs. Eight eligible studies involving 963 patients were included in this review. Compared with the placebo group, the FGF‐21 analog‐treated group exhibited significantly improved primary efficacy outcomes, specifically ≥1 stage improvement in fibrosis with no worsening of MASH (risk ratio [RR] = 1.83; 95% confidence interval [CI] = 1.27–2.62) and at least two‐point improvement in the non‐alcoholic fatty liver disease activity score with no worsening of fibrosis (RR = 2.85; 95% CI = 2.06–3.95). Despite an increased risk of TEAEs (RR = 1.17; 95% CI = 1.08–1.27) and treatment‐related adverse events (RR = 1.75; 95% CI = 1.40–2.19), FGF‐21 analogs exhibited an acceptable safety profile. FGF‐21 analogs were significantly better in achieving liver histological improvements and beneficial biochemical outcomes compared with placebo, with a tolerable safety pattern. These findings shed light on the efficacy and safety of FGF‐21 analogs and provide valuable evidence for their application as MASH therapeutics.

2024-06-01·Nature Medicine1区 · 医学

Author Correction: The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial

1区 · 医学

作者: ENTRIGUE Principal Investigators ; Bays, Harold E. ; Tseng, Leo ; Andrawis, Nabil S. ; Parli, Teresa ; Hartsfield, Cynthia L. ; Sterling, Lulu ; Wasilewska, Katarzyna ; Mansbach, Hank ; Cain, James E. III ; Agollah, Germaine D. ; Miller, Michael ; Kastelein, John J. P. ; Feng, Shibao ; Bhatt, Deepak L.

2024-03-01·Drug Discovery Today

NAFLD and NASH: etiology, targets and emerging therapies

Review

作者: Xu, Suowen ; Wang, Li ; Wei, Shulin ; Evans, Paul C

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) pose a significant threat to human health and cause a tremendous socioeconomic burden. Currently, the molecular mechanisms of NAFLD and NASH remain incompletely understood, and no effective pharmacotherapies have been approved. In the past five years, significant advances have been achieved in our understanding of the pathomechanisms and potential pharmacotherapies of NAFLD and NASH. Research advances include the investigation of the effects of the fibroblast growth factor 21 (FGF21) analog pegozafermin and the thyroid hormone receptor-β (THRβ) agonist resmetriom on hepatic fat content, NASH resolution and/or fibrosis regression. Future directions of NAFLD and NASH research (including combination therapy, organoids and humanized mouse models) are also discussed in this state-of-the-art review.

163

项与 Pegozafermin 相关的新闻（医药）

2025-01-13

·GlobeNewswire-Health Care

89bio Provides Business Update and Outlook for 2025

– Completed enrollment in Phase 3 ENTRUST trial in patients with severe hypertriglyceridemia (SHTG); topline 26-week data expected in the second half of 2025 – – The Phase 3 ENLIGHTEN program in patients with non-cirrhotic (F2-F3) and compensated cirrhotic (F4) metabolic dysfunction-associated steatohepatitis (MASH) continues to enroll patients across both trials – – Cash, cash equivalents, and marketable securities totaled approximately $440 million as of December 31, 2024 – SAN FRANCISCO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today provided a corporate update and business outlook for 2025. “Looking ahead to 2025, we are well-positioned to build on the momentum from the initiation and ongoing enrollment of our ENLIGHTEN Phase 3 program in MASH and the successful completion of enrollment in our ENTRUST Phase 3 trial in SHTG and expect to announce topline data from the Company’s first Phase 3 trial in the second half of 2025,” said Rohan Palekar, CEO of 89bio. “We remain confident in pegozafermin’s potential as a potent anti-fibrotic agent with broad cardio-metabolic benefits. With a strengthened leadership team, commercial-scale manufacturing available, and a bolstered financial position, we continue to advance our Phase 3 programs toward potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings, aiming to transform care for patients living with MASH and SHTG.” Key 2024 Highlights Completed enrollment in ENTRUST, the Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG. 89bio expects to report topline 26-week data from this trial in the second half of 2025.Initiated ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, the Phase 3 trials in non-cirrhotic (F2-F3) MASH patients with fibrosis and in compensated cirrhotic (F4) MASH patients, in March and May of 2024, respectively. Both MASH studies continue to enroll patients globally.Obtained regulatory feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on clinical as well as Chemistry, Manufacturing, and Controls (CMC) requirements for marketing authorization filings for pegozafermin. The Company remains on track for potential BLA and MAA filings, pending positive clinical data.Bolstered its balance sheet through the completed equity follow-on offering for $143.8 million in gross proceeds and an amended credit facility with K2 HealthVentures, providing an aggregate principal of up to $150.0 million. Cash, cash equivalents, and marketable securities totaled approximately $440 million as of December 31, 2024 (preliminary unaudited).Strengthened its executive leadership team and Board of Directors with four seasoned industry veterans. Appointments include Teresa Perney, Ph.D., Chief Regulatory and Quality Officer; Francis Sarena, Chief Operating Officer; Charles McWherter, Ph.D., Board of Directors; and Martin Babler, Board of Directors. These additions bring extensive operational, clinical, regulatory, and commercial expertise to 89bio. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn. Forward-looking StatementsCertain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of pegozafermin, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the topline results from the ENTRUST Phase 3 trial in SHTG and enrollment in clinical trials, including enrollment of the Phase 3 ENLIGHTEN-Fibrosis trial and Phase 3 ENLIGHTEN-Cirrhosis trial in MASH and 89bio’s potential BLA and MAA filings. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "anticipate," "goal," "opportunity," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio's filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bio's control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the timing and outcome of the ENLIGHTEN-Fibrosis Phase 3 trial and Phase 3 ENLIGHTEN-Cirrhosis trial in MASH and ENTRUST Phase 3 trial in SHTG; 89bio's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; 89bio's substantial dependence on the success of it lead product candidate; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of 89bio's capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Annie Chang89bio, Inc.annie.chang@89bio.com PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com Media Contact: Sheryl SeapyReal Chemistrysseapy@realchemistry.com

临床3期高管变更

2025-01-03

·Pharmaceutical Technology

Expanding diagnostic and biomarker options to improve MASH clinical trials

A liver doctor examines a model of the liver, focusing on diseases such as hepatitis, cirrhosis, and cancer, to explain diagnosis and treatment. Image credit: Shutterstock/PanuShot With diagnostics being integral in the detection, confirmation, and monitoring of disease, the lack of adequate and available diagnostics for metabolic dysfunction-associated steatohepatitis (MASH) studies can make aspects of a trial more laborious and cripple the conduct of a clinical study. MASH is a culmination of steatosis, inflammation, and fibrosis, and is also associated with comorbidities such as obesity and diabetes. With distinct mechanisms being required to address each facet of the disease, MASH can be complicated to treat. In March 2024, Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a type of thyroid hormone receptor beta (THR-beta) agonist, became the first and only approved therapy that does not require a liver biopsy for the treatment of patients with MASH and Stage 2–3 fibrosis. Other approaches that are in development include fibroblast growth factor (FGF) mimetics such as FGF21-targeting candidates like Akero Therapeutics’ efruxifermin and 89bio’s pegozafermin, as well as glucagon-like peptide-1 receptor agonists (GLP-1-RAs) like Eli Lilly’s retatrutide, which also targets GIP and glucagon. The consensus among experts is that the treatment of MASH will require the use of combination therapies. Though the therapeutic landscape is small, with only one approved drug to date, studies are ongoing and inching closer toward filling the treatment landscape despite the obstacles faced in trial design. Distinguishing the stages of fibrosis The presence of comorbidities like obesity, diabetes, and hypertension, and their significant overlap with MASH creates challenges with clinical study design, such as inclusion and exclusion criteria, says Dr. Mohammad Derakhshan, associate medical director at Parexel. Patients with MASH have different underlying pathophysiologies and their categorisation has not extended beyond grouping them as those with lean MASH and patients with other types of MASH. For example, patients in the Hispanic community have higher frequencies of the PNPLA3 gene, which leads to the “pineapple phenotype,” says Pol Boudes, CMO at Cambridge, Massachusetts-based Rectify Pharma. These patients are predisposed to a higher risk of progression and cirrhosis, which leads to a higher risk for decompensation, he elaborates. Furthermore, the lack of visible symptoms particularly when it comes to determining the stage of fibrosis is a challenge with MASH, says Boudes. Most patients are not aware that they have stage 4 fibrosis at diagnosis, and this comes down to a lack of awareness about the symptoms, he explains. “In terms of medical need, the most pressing need would be to better differentiate F4 and F3 [stages of fibrosis],” says Boudes. The barrier of requiring a liver biopsy While there is ongoing research to develop better tools like biochemical markers to differentiate fibrosis stage in MASH patients, the only standard currently used in MASH clinical studies involves liver biopsies at the time of diagnosis. Experts agree this can be strenuous and difficult for the participant and the physician. “It is not so much that the biopsy is difficult, but it depends on your patient,” says Boudes. Biopsies can be difficult for obese patients and those at an advanced stage of fibrosis. Requiring a liver biopsy is a significant barrier in clinical trials, particularly when it comes time to take the second biopsy at the end of the study, says Dave Happel, CEO of Sagimet Biosciences. Moreover, while it is well understood that requiring a liver biopsy creates a barrier, it is still the best way to understand if the disease has progressed or regressed, Happel explains. Happel says patients often drop out from trials when they require additional liver biopsies. “And I think that is why you overpower these studies so significantly: in anticipation of people dropping out because they don’t want to get the biopsy,” says Happel. Furthermore, it is why Sagimet has designed its Phase III FASCINATE-3 study (NCT06594523) of fat inhibitor denifanstat to include an 18-month enrollment period, he explains. Alan Baldridge, senior development director in Hepatology at ICON, says the field is between a rock and a hard place when it comes to the need and use of liver biopsies in MASH studies. “It [liver biopsies] is uncomfortable, invasive, and it has some risks associated with it so our patients don’t particularly care for it,” he says. Additionally, liver biopsies are associated with high variability, in terms of intra and inter-reader variability, the “waxing and waning” nature of the disease, and variability depending on where the liver sample is taken, Baldridge explains. With industry consensus on the limitations of liver biopsy, there have been advances in non-invasive or minimally invasive markers, such as serum biochemical markers or imaging markers of fibrosis, which can provide more information about the liver. Minimally invasive and non-invasive tests such as magnetic resonance imaging (MRI) scans are more sensitive in MASH because a physician can see a more holistic picture of the liver as opposed to a segment of the liver collected through biopsy, says Baldridge. The drawback, however, is that regulatory bodies are “less keen” on validating these markers for clinical trials, he adds. The use of liver biopsy is ultimately a question of context, says Boudes. “As a clinician coming back to a standard case [of MASH], an endocrinologist will not push for liver biopsy because it makes no sense to your medical practice,” says Boudes. Baldridge agrees, noting that in clinical care, less than 10% of MASH patients will get liver biopsies to confirm their diagnosis. However, it is important to distinguish that while standard practice would gravitate towards the minimally invasive FibroScan or MRI diagnostics, clinical trials are and must be biopsy-driven by necessity, says Baldridge.

上市批准临床3期

2024-12-19

·GlobeNewswire-Health Care

89bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

SAN FRANCISCO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (the “Company” or “89bio”) (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 48,000 shares of the Company’s common stock to one new employee (the “Inducement Grant”) on December 13, 2024 (the “Grant Date”). The Inducement Grant has been granted pursuant to the Company’s 2023 Inducement Plan (the “Plan”). The Inducement Grant was granted as an inducement material to the individual entering into employment with 89bio in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Grant has an exercise price per share that is equal to the closing price of 89bio’s common stock on the Grant Date. The Inducement Grant will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the employee’s start date, and thereafter the remainder of the shares vest in 12 equal quarterly installments, subject to the employee’s continued employment with 89bio through the applicable vesting dates. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn. Investor Contact:Annie Chang89bio, Inc.investors@89bio.com PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com Media Contact:Sheryl SeapyReal Chemistrysseapy@realchemistry.com

临床3期

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,

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适应症	最高研发状态	国家/地区	公司	日期
高甘油三酯血症	临床3期	英国	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	奥地利	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	捷克	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	墨西哥	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	美国	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	拉脱维亚	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	比利时	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	智利	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	德国	89bio, Inc.	2023-06-15
高甘油三酯血症	临床3期	印度	89bio, Inc.	2023-06-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04541186 (ENTRIGUE STUDY, CTgov)	临床2期	高甘油三酯血症	86	Placebo (Placebo)	網鹽廠築願遞蓋醖糧醖(鑰鹽鹹願觸夢鏇淵壓積) = 膚網構襯憲繭構壓齋壓選糧觸淵廠艱構壓壓糧 (窪構淵鏇簾齋範鬱醖蓋, 構願範網憲憲網膚獵餘 ~ 積網廠餘獵醖糧窪獵構) 更多	-	2024-07-25
				Pegozafermin (Pegozafermin 9 mg QW)	鏇糧鹽艱膚築範構淵窪(積遞網觸繭簾壓艱顧餘) = 糧淵夢簾夢願範積鬱襯淵膚齋廠廠遞獵製壓遞 (獵遞醖齋襯夢鬱選鹽觸, 鏇齋獵顧顧網鹽願顧繭 ~ 鹽築顧膚衊製鬱製網簾) 更多
NCT04048135 (CTgov)	临床1/2期	非酒精性脂肪性肝炎	101	Pegozafermin (Part 1: Pegozafermin 9 mg QW)	鑰網鬱膚築鏇觸網獵積(獵憲範憲獵積鏇鑰簾顧) = 壓壓窪觸鹹鏇構蓋願窪廠鏇淵築糧蓋鬱窪醖遞 (夢憲夢製範鬱襯範糧憲, 鬱糧窪艱鹽顧遞醖壓鑰 ~ 網積淵觸網壓鏇憲觸鬱) 更多	-	2024-04-02
				Pegozafermin (Part 1: Pegozafermin 18 mg QW)	鑰網鬱膚築鏇觸網獵積(獵憲範憲獵積鏇鑰簾顧) = 網憲範蓋顧廠衊獵鏇構廠鏇淵築糧蓋鬱窪醖遞 (夢憲夢製範鬱襯範糧憲, 齋糧鬱構範網壓積糧夢 ~ 製鏇簾遞構齋製壓獵範) 更多
NCT04929483 (ENLIVEN , Biospace) 人工标引	临床2期	非酒精性脂肪性肝炎	130	Pegozafermin 30mg QW	(鬱願襯廠醖繭範夢顧鏇) = 獵範淵獵獵醖醖鏇獵壓網齋積願製鬱選願製鏇 (鏇憲餘積膚範構鑰艱願 ) 更多	积极	2023-11-27
				Pegozafermin 44mg Q2W	(鬱願襯廠醖繭範夢顧鏇) = 網網壓遞獵鏇願獵鹹鏇網齋積願製鬱選願製鏇 (鏇憲餘積膚範構鑰艱願 ) 更多
NCT04929483 (ENLIVEN, GlobeNewswire) 人工标引	临床2期	非酒精性脂肪性肝炎	13	Pegozafermin	(窪選廠願築觸積網衊憲) = 築蓋網醖淵衊餘醖遞製鏇廠範衊醖衊選憲壓齋 (鹽鑰構齋衊繭鬱範淵選 ) 更多	积极	2023-11-12
				Placebo	(窪選廠願築觸積網衊憲) = 廠獵淵淵蓋壓選夢窪遞鏇廠範衊醖衊選憲壓齋 (鹽鑰構齋衊繭鬱範淵選 ) 更多
NCT04541186 (ENTRIGUE STUDY, NASH_TAG2023)	临床2期	高甘油三酯血症 HbA1c \| fasting insulin \| plasma glucose	-	Pegozafermin	遞鏇獵壓襯淵選膚繭製(積衊鬱鏇鏇齋願網範製) = 糧襯鬱鏇糧願窪選範淵艱衊鏇構鑰獵糧遞窪顧 (簾選夢願鏇構醖窪艱繭 ) 更多	积极	2023-01-05
				Placebo	遞鏇獵壓襯淵選膚繭製(積衊鬱鏇鏇齋願網範製) = 夢艱餘衊廠構鹽醖遞鏇艱衊鏇構鑰獵糧遞窪顧 (簾選夢願鏇構醖窪艱繭 )
RF32 \| PSUN58 BIO89-100 (ENDO2022)	临床1/2期	非酒精性脂肪性肝炎 HFF \| HOMA-IR \| Adipo-IR ... 更多	81	BIO89-100	(齋夢襯襯糧憲衊積獵顧) = 鏇遞築糧鹽艱願構艱積糧願艱鹽繭鬱鹽製醖夢 (齋鹹鬱製衊醖糧積製範, 137.6 ~ 504.4)	积极	2022-11-01
				Placebo	(齋夢襯襯糧憲衊積獵顧) = 醖衊繭網簾鹹壓製壓選糧願艱鹽繭鬱鹽製醖夢 (齋鹹鬱製衊醖糧積製範, 107.6–366.9)
EASL2021	临床1/2期	非酒精性脂肪性肝炎	81	BIO89-100 3 mg QW	廠範壓遞憲襯醖襯齋鑰(淵壓觸築窪製夢醖製範) = 鬱積鹽醖顧淵壓壓築簾蓋網選衊襯鬱願壓簾遞 (窪顧糧築醖壓顧鑰衊襯 ) 更多	积极	2021-06-23
				BIO89-100 9 mg QW	廠範壓遞憲襯醖襯齋鑰(淵壓觸築窪製夢醖製範) = 觸廠顧襯構膚遞鹽齋壓蓋網選衊襯鬱願壓簾遞 (窪顧糧築醖壓顧鑰衊襯 ) 更多
BIO89-100 (NASH_TAG2020)	临床1期	-	58	BIO89-100 9.1 mg	(衊窪觸製淵簾膚鏇遞鹽) = all reported as mild 願鏇範製構鬱糧艱糧蓋 (選廠夢顧淵蓋夢憲網憲 ) 更多	积极	2020-01-09
				Placebo