A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH).

Start Date18 Nov 2024

Sponsor / Collaborator

Akero Therapeutics, Inc.

NCT06528314 / RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrohosis Due to NASH/MASH

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Start Date04 Sep 2024

Sponsor / Collaborator

Akero Therapeutics, Inc.

CTIS2023-505141-48-00 / Recruiting

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/MetabolicDysfunction-Associated Steatohepatitis (MASH) and Fibrosis - AK-US-001-0105

Start Date15 Mar 2024

Sponsor / Collaborator

Akero Therapeutics, Inc.

100 Clinical Results associated with Efruxifermin

100 Translational Medicine associated with Efruxifermin

100 Patents (Medical) associated with Efruxifermin

Literatures (Medical) associated with Efruxifermin

01 Dec 2024·Environmental Pollution

Swine wastewater co-exposed with veterinary antibiotics enhanced the antibiotic resistance of endophytes in radish (Raphanus sativus L.)

Article

Author: Song, Chao ; White, Jason C. ; Chuan-Xin, Ma ; Gao, Fang-Zhou ; White, Jason C ; Chen, Chang-Er ; Ma, Chuan-Xin ; Jia, Wei-Li ; Ying, Guang-Guo

The widespread utilization of antibiotics in livestock has promoted the accumulation and diffusion of antibiotics and antibiotic resistance in agricultural soils and crops. Here we investigated the mechanisms of antibiotic uptake and accumulation in swine wastewater (SW)-treated radish (Raphanus sativus L.) and subsequent impacts on endophyte antibiotic resistance. Under SW treatments, exposure to 500 μg/L sulfamethazine (SMZ) and enrofloxacin (EFX) significantly affected radish biomass, with SMZ causing 63.0% increases and EFX causing 36.3% decreases relative to the untreated control. EFX uptake by radish were from 5 to 100-folds over SMZ. Passive diffusion through anion channel proteins on cell membranes was an important route for SMZ uptake, while both passive diffusion and energy-dependent processes contributed to the uptake of EFX. Bacterial community was time-dependent as a function of both antibiotics and SW, the bacterial alpha diversity in liquid solution co-treated with antibiotics and SW increased over time. The abundance of antibiotic resistance genes (ARGs) in the roots was positively correlated with ARGs in the Hoagland's solution under antibiotic-alone treatments. EFX co-exposure with SW enhanced the dissemination of ARGs from swine wastewater into plant roots, and significant correlations existed between ARGs and integrons in both Hoagland's solution and roots. These findings increased our understanding of the fate of antibiotics in crops and their subsequent impacts on antibiotic resistance of endophytic bacteria.

01 Jul 2024·Journal of Gastroenterology and Hepatology

Efficacy of pharmacologic interventions on magnetic resonance imaging biomarkers in patients with nonalcoholic fatty liver disease: systematic review and network meta‐analysis

Review

Author: Liakos, Aris ; Sarakapina, Anna ; Malandris, Konstantinos ; Bekiari, Eleni ; Papandreou, Stylianos ; Giouleme, Olga ; Kalopitas, Georgios ; Iatridi, Fotini ; Kakotrichi, Panagiota ; Karagiannis, Thomas ; Sinakos, Emmanouil ; Paschos, Paschalis ; Tsapas, Apostolos ; Vasilakou, Despoina

AbstractBackground and AimSeveral agents are under investigation for nonalcoholic fatty liver disease (NAFLD). We assessed the comparative efficacy of pharmacologic interventions for patients with NAFLD focusing on magnetic resonance imaging (MRI) biomarkers.MethodsWe searched Medline, Embase, and CENTRAL. We included randomized controlled trials of more than 12 weeks of intervention that recruited patients with biopsy‐confirmed or MRI‐confirmed NAFLD and assessed the efficacy of interventions on liver fat content (LFC) and fibrosis by means of MRI. We performed random‐effects frequentist network meta‐analyses and assessed confidence in our estimates using the CINeMA (Confidence in Network Meta‐Analysis) approach.ResultsWe included 47 trials (8583 patients). Versus placebo, thiazolidinediones were the most efficacious for the absolute change in LFC, followed by vitamin E, fibroblast growth factor (FGF) analogs, and glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) with mean differences ranging from −7.46% (95% confidence interval [−11.0, −3.9]) to −4.36% (−7.2, −1.5). No differences between drug classes were evident. Patients receiving GLP‐1 RAs or glucose‐dependent insulinotropic polypeptide (GIP)/GLP‐1 RAs were more likely to achieve ≥30% relative reduction in LFC. Among agents, efruxifermin produced the largest reduction in LFC compared to placebo [−13.5% (−18.5, −8.5)], followed by pioglitazone, while being superior to most interventions. The effect of interventions on magnetic resonance elastography assessed fibrosis was small and insignificant. The confidence in our estimates was low to very low.ConclusionsSeveral drug classes may reduce LFC in patients with NAFLD without a significant effect on fibrosis; nevertheless, trial duration was small, and confidence in the effect estimates was low.

01 Jul 2024·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

Author: 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.

128

News (Medical) associated with Efruxifermin

15 Nov 2024

·www.globenewswire.com

Akero Therapeutics to Showcase New Analyses of Phase 2b HARMONY Study in Presentations at 75th Annual AASLD The Liver Meeting® 2024

-- Over 40% of participants treated with EFX 50mg for 96 weeks, compared with 0% for placebo, showed regression of liver fibrosis by all of three orthogonal measures: (1) ≥1-stage fibrosis improvement by NASH-CRN stage (conventional histopathology), (2) 30% reduction of liver stiffness by FibroScan® (imaging fibrosis biomarker), and (3) 0.5 point decrease in ELFTM score (serum fibrosis biomarker) – -- Analysis of biopsies by AI-based Digital Pathology (qFibrosis®, Histoindex) corroborated the extent of improvement in fibrosis observed with conventional histopathology after 24 and 96 weeks of EFX treatment, including statistically significant reductions in fibrosis within the perisinusoidal and periportal zones of the liver – -- 30% of participants receiving EFX 50mg for 96 weeks, compared to 0% for placebo, had almost complete reversal of MASH-related disease, as indicated by reversal of fibrosis to F≤1, resolution of steatohepatitis, and normalization of fat content to ≤5% SOUTH SAN FRANCISCO, Calif., Nov. 15, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced results of analyses supporting the clinical activity of efruxifermin (EFX) in metabolic dysfunction-associated steatohepatitis (MASH) in one oral presentation and two late-breaking poster presentations at the 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, held November 15-19, 2024, in San Diego. “The data to be presented at The Liver Meeting® show that 96 weeks of treatment with EFX has the potential to drive substantial reversal of disease in patients living with pre-cirrhotic MASH,” said Kitty Yale, chief development officer of Akero. “We are encouraged by consistent improvements observed across a number of clinically established markers of liver health and the corroboration of conventional histopathology assessments with Artificial Intelligence (AI)-based digital pathology. We believe these new analyses provide further evidence for the potential of EFX to be a differentiated therapy for MASH.” An oral presentation will highlight findings from the completed 96-week Phase 2b HARMONY study in patients with pre-cirrhotic MASH, fibrosis stages F2-F3. These findings include assessment of liver biopsies by conventional histopathology and AI-based digital pathology, as well as analyses of individual participants’ responses across clinically established measures of liver fibrosis: AI-based digital pathology scoring of fibrosis (by HistoIndex, using their proprietary qFibrosis scoring) corroborated the EFX-associated histopathologic improvements scored by per-protocol consensus reads, and highlighted statistically significant EFX-associated reductions in qFibrosis® in both the perisinusoidal and periportal zones of the liver after 24 and 96 weeks of treatment.In addition, analysis of changes in multi-modal, non-invasive markers of liver fibrosis among individual participants showed that: More than half of individuals treated with EFX 50mg experienced clinically meaningful reductions in both widely used non-invasive tests of fibrosis (liver stiffness by FibroScan® vibration-controlled transient elastrography [VCTE] and Enhanced Liver Fibrosis [ELFTM] Test), approximately nine-fold the rate of placebo.Over 40% of individuals treated with EFX 50mg for 96 weeks experienced improved fibrosis by conventional histopathology, as well as clinically meaningful improvements in imaging (liver stiffness by FibroScan®) and serum (ELFTM score) biomarkers of liver fibrosis, compared with 0% of individuals on placebo.The proportion of individuals who responded to EFX 28 mg was smaller than that for EFX 50mg based on these same measures: Proportions of Participants with Improved Liver Fibrosis as Indicated by Congruence of Improvements in Non-Invasive Markers of Fibrosis and Conventional Histopathology After EFX Treatment Responder Type (Proportion of Participants)1Placebo (N=32)EFX 28mg (N=26)EFX 50mg (N=24)ELFTM(≥0.5 absolute reduction in score)25%58%71%Liver Stiffness(≥30% relative reduction by FibroScan® VCTE)19%50%71%ELFTM + Liver Stiffness6%38%54%ELFTM + Liver Stiffness + Histopathology20%19%42% 1 Based on those patients with baseline and Week 96 measurements of ELFTM score, liver stiffness (FibroScan®), and conventional histopathology2 Fibrosis improvement ≥1 stage without MASH worsening, by conventional histopathology One poster (#5047) presents an orthogonal analysis of baseline, week 24, and week 96 liver biopsies from HARMONY by HistoIndex. This analysis corroborates the pattern of anti-fibrotic effects observed with conventional pathology after treatment with EFX for 24 or 96 weeks. Specifically, a quantitative analysis by qFibrosis® across different zones of the liver revealed EFX-associated reductions in fibrosis primarily in the perisinusoidal and periportal zones that were sustained or expanded from weeks 24 through 96 for participants, regardless of baseline fibrosis stage. The second poster (#5021) presentation shows that 30% of participants receiving EFX 50mg for 96 weeks had almost complete reversal of MASH-related disease, as indicated by reversal of fibrosis to F≤1, resolution of MASH, and normalization of liver fat content to ≤5%, compared to 0% of participants on placebo. In addition, 100% of participants who received EFX 50mg for 96 weeks were categorized as “low risk of progressive MASH” (i.e., MASH with F≥2, NAS≥4) by FibroScan®-AST (FAST) score. In contrast, 48% of participants receiving placebo remained at high or indeterminate risk of progressive MASH. Based on the same analyses, the extent of reversal of disease relative to placebo was smaller for participants receiving EFX 28mg than 50mg. “We believe that, taken together, the suite of presentations provides evidence supporting the consistent anti-fibrotic effects of EFX observed to date in the HARMONY trial as well as the the clinical activity and generally favorable safety profile of EFX in patients with precirrhotic MASH (F2-F3). The ongoing Phase 3 SYNCHRONY program is designed to confirm a favorable benefit-risk profile and support marketing applications for EFX for the treatment of MASH,” said Ms. Yale. Details for the presentations are as follows: Title: Efruxifermin Significantly Improved Liver Fibrosis at Week 96 in the HARMONY Study Across Subgroups and Improvements Were Associated With Changes in BiomarkersSpeaker: Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research InstituteDate/Time: Sunday, November 17, 2024, from 2:00 PM – 2:15 PM PST Publication Number: 158Oral Session: MASLD and MASH – New Therapies Title: AI and digital-based pathology corroborate reduction in fibrosis observed by conventional pathology with efruxifermin treatment of patients with F2-F3 MASH in the HARMONY studyPresenter: Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research Institute Date/Time: Monday, November 18, 2024, from 8:00 AM – 5:00 PM PSTPublication Number: 5047Session: Late Breaking Posters Title: Efruxifermin significantly reduced proportion of subjects with at-risk MASH and led to near-complete histological disease reversal at week 96 in the HARMONY studyPresenter: Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research Institute Date/Time: Monday, November 18, 2024, from 8:00 AM – 5:00 PM PST Publication Number: 5021Session: Late Breaking Posters About Akero TherapeuticsAkero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH. Akero’s lead product candidate, EFX, is currently being evaluated in three ongoing Phase 3 clinical trials in patients with pre-cirrhotic MASH (F2-F3) or compensated cirrhosis (F4) due to MASH: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes. The SYNCHRONY program builds on the results of two Phase 2b clinical trials, the completed HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the ongoing SYMMETRY study in patients with compensated cirrhosis (F4) due to MASH, in which more than 300 patients have been treated with EFX or placebo for up to 96 weeks. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero’s business plans and objectives, including future plans orexpectations for EFX and its potential differentiated profile; the therapeutic effects of EFX; as well as the dosing, clinical activity,safety and tolerability of EFX. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero’s product candidate development activities and planned clinical trials; Akero’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; regulatory developments in the United States and foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in Akero’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact:Christina Tartaglia Precision AQ212.362.1200christina.tartaglia@precisionaq.com Media Contact:Peg Rusconi Deerfield GroupPeg.rusconi@deerfieldgroup.com

Clinical ResultPhase 2Phase 3

15 Nov 2024

·endpts.com

Boston Pharmaceuticals hits Phase 2 goals as it tries to keep up with MASH competitors

Boston Pharmaceuticals succeeded on two closely watched efficacy endpoints for its Phase 2 MASH study, putting the company in contention with other biotechs seeking to treat the liver disease. The company reported Friday that its FGF21 analog, called efimosfermin alfa, spurred a statistically significant improvement in both fibrosis without worsening of MASH, and resolution of MASH without worsening of fibrosis. The new data assessed the once-monthly shot over 24 weeks in 84 patients with advanced stages of MASH, also known as metabolic dysfunction-associated steatohepatitis. The company said it plans to discuss the data with regulators and advance the drug into late-stage development next year. As is frequently the case in MASH studies, efimosfermin was considerably better at resolving MASH than improving fibrosis, a type of liver scarring that’s a hallmark of the disease. In the group treated with efimosfermin, 67.7% had their MASH disease improve without their fibrosis worsening, compared with 29.4% of patients given placebo. For the fibrosis endpoint, which uses a scale to measure liver scarring, 45.2% of patients getting the drug had at least a one-stage improvement without worsening of MASH, compared to 20.6% of patients on placebo. Boston didn’t report a statistically significant number of treated patients who had both MASH resolution and fibrosis improvement compared to placebo, a higher bar than the other two endpoints. The trial’s primary endpoints were safety and tolerability, according to a government database of trials. Patients receiving efimosfermin had low discontinuation rates, according to the company, and “an overall low incidence of gastrointestinal side effects and injection site reactions.” The data bode well for Boston’s prospects in the larger FGF21 race , though it still trails two other biotechs that are slightly ahead: Akero Therapeutics’ efruxifermin is in the middle of two Phase 3 studies, as is 89bio. All three companies are looking to carve out a slice of the market that Madrigal Pharmaceuticals currently has to itself. Madrigal’s treatment, Rezdiffra, became the first to win FDA approval to treat the underlying biology of MASH earlier this year and recently impressed investors with more than $62 million in third-quarter revenue. Novo Nordisk could become a competitor, too, after posting positive Phase 3 data earlier this month with plans to file for regulatory approval in the US and EU in the first half of 2025.

Phase 2Clinical ResultPhase 3

15 Nov 2024

·firstwordpharma.com

Boston Pharma touts significant fibrosis, MASH reversal with once-monthly drug

Boston Pharmaceuticals unveiled mid-stage results for its FGF21 analogue efimosfermin alfa (BOS-580) on Friday, highlighting its potential to improve fibrosis and resolve metabolic dysfunction-associated steatohepatitis (MASH), all while offering the convenience of a monthly dosing regimen. The company plans to move the programme into late-stage testing in 2025.The Phase II study randomised 84 patients with biopsy-confirmed F2 or F3 MASH to once-monthly efimosfermin 300 mg dosed subcutaneously or placebo.After 24 weeks, results from 65 patients showed that nearly half (45.2%) of those treated with efimosfermin had improved liver fibrosis by at least one stage without their MASH worsening, compared to 20.6% in the placebo group. Over two-thirds (67.7%) of patients on efimosfermin saw their MASH resolve without further damage to their liver, versus 29.4% for those in the placebo arm. When looking at both fibrosis improvement and MASH resolution together, 38.7% of efimosfermin patients met these goals, more than double the 17.6% seen in the placebo group.Boston Pharma said the drug also delivered "rapid and significant" benefits across key cardiometabolic markers. Study participants showed significant reductions in liver fat content, markers of liver injury, and improvements in glycaemic control. Topline results will be presented on next week at the American Association for the Study of Liver Diseases (AASLD) annual meeting."We believe these data, together with upcoming results from our extension study and our advanced fibrosis study, will enable us to build a comprehensive package for discussions with regulatory authorities ahead of our entry into pivotal studies," said CEO Sophie Kornowski.Earlier this year, Akero Therapeutics reported that its lead asset efruxifermin, which has also been engineered to mimic the biological activity of FGF21, achieved fibrosis improvement of at least one stage without worsening MASH in 41% of patients on the 50 mg dose and 39% on the 28 mg dose after 24 weeks.".Meanwhile, 89bio's FGF21 analogue pegozafermin has demonstrated 27% and 26% rates on this endpoint for its 44 mg every-two-week and 30 mg weekly doses, respectively, the Phase IIb ENLIVEN trial. The company began a Phase III study in May to test pegozafermin in MASH patients with compensated cirrhosis that could potentially support an accelerated approval filing in the US and conditional approval in Europe. See – Why 89bio feels confident on MASH accelerated approval pathway.

Phase 2Clinical Result

100 Deals associated with Efruxifermin

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 3	US	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	KR	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	CA	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	IL	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	PR	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	IN	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	GB	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	TR	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	CH	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic Steatohepatitis	Phase 3	AU	Akero Therapeutics, Inc.	10 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04767529 (HARMONY, Corporate Publications) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	128	efruxifermin 28mg (Primary Analysis)	(hqeyscodht) = cnqqbdrkdx snkyorplng (ftzreiylwa ) View more	Positive	04 Mar 2024
				efruxifermin 50mg (Primary Analysis)	(hqeyscodht) = ahwouupldv snkyorplng (ftzreiylwa ) View more
NCT05039450 (AK-US-001-0103, Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis	31	Efruxifermin 50 mg+GLP-1 Receptor Agonist	(eqnppocpdu) = The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated. The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events. bnykqeweia (bofzmenvmc )	Positive	01 Mar 2024
				Placebo+GLP-1 Receptor Agonist
NCT04767529 (HARMONY, Pubmed \| Lancet Gastroenterol Hepatol) Manual	Phase 2	Nonalcoholic Steatohepatitis	128	Efruxifermin 28 mg	(ojzqjeoubt) = dwsewjloak yszpyqortl (bmepreaybg ) View more	Positive	01 Dec 2023
				Efruxifermin 50 mg	(ojzqjeoubt) = idrniufuto yszpyqortl (bmepreaybg ) View more
NCT05039450 (SYMMETRY, Corporate Publications) Manual	Phase 2	Nonalcoholic Steatohepatitis	182	Efruxifermin 28 mg	(zznyjddstr) = ysepdjdadx gpsrsfxgrv (sfqyaehqmv ) View more	Negative	10 Oct 2023
				Efruxifermin 50 mg	(zznyjddstr) = lmrrahobhn gpsrsfxgrv (sfqyaehqmv ) View more
NCT03976401 (Pubmed)	Phase 2	Nonalcoholic Steatohepatitis \| Fibrosis	30	Efruxifermin 50 mg	(dfffprmapr) = Significant improvements were noted in key markers of liver injury (alanine aminotransferase) and glucose and lipid metabolism kielcwgxci (cewidxrjiv )	-	01 Jan 2023
				Placebo
BALANCED study (EASL2021)	Phase 2	Fibrosis \| Fatty Liver \| Liver Injury	80	Efruxifermin	xuauqbrvkv(sgyuydzqzl): Odds Ratio = 4.083 (95% CI, 1.122 - 14.863), P-Value = 0.0365 View more	-	23 Jun 2021
				Placebo

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