5001 A PHASE 2, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF PEMVIDUTIDE IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS Mazen Noureddin1Stephen Harrison2Rohit Loomba3Naim Alkhouri4Naga Chalasani5Shaheen Tomah6Julio Gutierrez7John Suschak8Scot Roberts9Rachel Garner8Sarah Browne8Scott Harris6, 1Houston Methodist Hospital,2University of Oxford,3University of California, San Diego,4Summit Clinical Research,5Indiana University Medical Center,6Altimmune,7Scripps Clinic,8Altimmune, Inc,9Altimmune, Inc. Background: Pemvidutide is a balanced (1:1) GLP-1/glucagon dual receptor agonist in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). IMPACT is a Phase 2, randomized, placebo-controlled, double-blind trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3 (NCT05989711). Here, we present the results of the primary analyses of the study at 24 weeks of treatment. Methods: From July 27, 2023 to April 29, 2025, 212 patients were randomized 1:2:2 to receive once-weekly subcutaneous pemvidutide (1.2 mg or 1.8 mg) administered without dose titration, or placebo. The mean age was 53 yrs, the mean BMI was 39 kg/m2, 58% were female, and 43% had type 2 diabetes. The dual primary endpoints were MASH resolution without worsening of fibrosis or ≥1 stage liver fibrosis improvement without worsening of MASH at 24 weeks. An ITT analysis (N=212) was employed in which patients with missing biopsy data or who discontinued treatment early were considered non-responders. Results: MASH resolution without fibrosis worsening was observed in 18 [20%] of 86 patients in the placebo group, 24 [58%] of 41 patients in the 1.2 mg pemvidutide group (95% CI, 21 to 56; p<0.0001), and 45 [52%] of 85 patients in the 1.8 mg pemvidutide group (95% CI, 19 to 46; p<0.0001). Fibrosis improvement without worsening of MASH was observed in 24 [28%] of 86 patients in the placebo group, 13 [33%] of 41 patients in the 1.2 mg pemvidutide group (95% CI, -13 to 22; p=0.59), and 30 [36%] of 85 patients in the 1.8 mg pemvidutide group (95% CI, -6 to 22; p=0.27). AI-based analyses of the liver biopsies and non-invasive tests for MASH and fibrosis were statistically significant at both pemvidutide doses, consistent with an ongoing anti-fibrotic effect (Table 1). Mean weight losses were 0.5% in the placebo group vs. 4.8% (p<0.001) in the 1.2 mg group and 5.8% (p<0.001) in 1.8 mg group. Pemvidutide was well-tolerated despite the absence of dose titration, with discontinuations due to adverse events of 2%, 0%, and 1%, in the placebo, 1.2 mg, and 1.8 mg groups, respectively. Conclusion: Pemvidutide was well tolerated without dose titration and led to significant MASH resolution, weight loss, and antifibrotic activity at only 24 weeks of treatment.Disclosures: Mazen Noureddin: ltimmune, BI, Cytodyn, 89BIO, GSK, Madrigal, Merck, Novo Nor: Terns,Takeda, Zydus., Allergan, Akero, BI, BMS, Gilead, Galectin, Zydus GSK: Terns, Corcept, Takeda, Madrigal, Novartis, Novo Nordisk, Rivus Pharma, Cytodyn, and ChronWell: Stock – privately held company, Altimmune: Consultant, Alligos: Consultant, AstraZeneca: Consultant, BI: Consultant, Boston Pharmaceuticals: Consultant, Cytodyn: Consultant, GSK: Consultant, Eli Lilly: Consultant, Madrigal: Consultant, Merck: Consultant, Novo Nordisk: Consultant, Terns: Consultant, Takeda: Consultant, Allergan: Principal Investigator for a Drug Study, Akero: Principal Investigator for a Drug Study, BI: Principal Investigator for a Drug Study, BMS: Principal Investigator for a Drug Study, Gilead: Principal Investigator for a Drug Study, Galectin: Principal Investigator for a Drug Study, Genfit: Principal Investigator for a Drug Study, GSK: Principal Investigator for a Drug Study, Conatus: Principal Investigator for a Drug Study, Corcept: Principal Investigator for a Drug Study, Enanta: Principal Investigator for a Drug Study, Madrigal: Principal Investigator for a Drug Study, Novartis: Principal Investigator for a Drug Study, Novo Nordisk: Principal Investigator for a Drug Study, Shire: Principal Investigator for a Drug Study, Takeda: Principal Investigator for a Drug Study, Terns: Principal Investigator for a Drug Study, Viking: Principal Investigator for a Drug Study, Zydus: Principal Investigator for a Drug Study, Rivus Pharmaceuticals: Stock – privately held company, Cytodyn: Stock - publicly traded company, ChronWell: Stock – privately held company, Madrigal: Speaking and Teaching, Akero: Stock – privately held company, Akero: Advisor, Alligos: Advisor, Altimmune: Advisor, AstraZeneca: Advisor, Boehringer Ingelheim: Advisor, Boston Pharma: Advisor, Cytodyn: Advisor, GSK: Advisor, Lilly: Advisor, Madrigal: Advisor, Merck: Advisor, Novo Nordisk: Advisor, Sagimet: Advisor, Terns: Advisor, Takeda: Advisor, Akero: Principal Investigator, Allergan: Principal Investigator, Altimmune: Principal Investigator, Boehringer Ingelheim: Principal Investigator, Bristol Myers Squibb: Principal Investigator, Boston Pharma: Principal Investigator, Conatus: Principal Investigator, Corcept: Principal Investigator, Galectin: Principal Investigator, Genfit: Principal Investigator, GSK: Principal Investigator, Kowa: Principal Investigator, Enanta: Principal Investigator, Madrigal: Principal Investigator, Lilly: Principal Investigator, Merck: Principal Investigator, Novartis: Principal Investigator, Novo Nordisk: Principal Investigator, Rivus: Principal Investigator, Shire: Principal Investigator, Takeda: Principal Investigator, Terns: Principal Investigator, Viking: Principal Investigator, Zydus: Principal Investigator, Rivus: Stock – privately held company, Cytodyn: Stock - publicly traded company, ChronWell: Stock – privately held company, Madrigal: Speakers bureau, Conatus: Principal Investigator, Gilead Sciences: Principal Investigator, Akero: Consultant, Altimmune: Consultant, Alligos: Consultant, AstraZeneca: Consultant, BI: Consultant, Boston Pharma: Consultant, Curve bioscience: Consultant, Cytodyn: Consultant, GSK: Consultant, Histoindex: Consultant, Lilly: Consultant, Madrigal: Consultant, Merck: Consultant, Novo Nordisk: Consultant, Rivus, Sagimet: Consultant, Rivus: Consultant, Sagimet: Consultant, Terns: Consultant, Allergan: Grant/Research Support, Altimmune: Grant/Research Support, Akero: Grant/Research Support, BI: Grant/Research Support, BMS: Grant/Research Support, Boston Pharma: Grant/Research Support, Conatus: Grant/Research Support, Corcept: Grant/Research Support, Gilead: Grant/Research Support, Galectin: Grant/Research Support, Genfit: Grant/Research Support, GSK: Grant/Research Support, Kowa: Grant/Research Support, Enanta: Grant/Research Support, Madrigal: Grant/Research Support, Lilly: Grant/Research Support, Merck: Grant/Research Support, Novartis: Grant/Research Support, Novo Nordisk: Grant/Research Support, Rivus: Grant/Research Support, Shire: Grant/Research Support, Takeda: Grant/Research Support, Terns: Grant/Research Support, Viking: Grant/Research Support, Rivus Pharma: Stock – privately held company, Akero: Stock - publicly traded company, Zydus: Grant/Research Support, Takeda: Consultant, Madrigal: Speaking and Teaching, Novo Nordisk: Speaking and Teaching, Takeda: Consultant, Stephen Harrison:, Rohit Loomba: Eli Lilly and Company: Consultant, 89bio: Consultant, Aardvark Therapeutics: Consultant, Altimmune: Consultant, Alnylam/Regeneron: Consultant, Amgen: Consultant, Arrowhead Pharmaceuticals: Consultant, AstraZeneca: Consultant, Bristol Myers Squibb: Consultant, CohBar: Consultant, Eli Lilly: Consultant, Galmed Pharmaceuticals: Consultant, Gilead: Consultant, Glympse Bio: Consultant, Hightide: Consultant, Inipharma: Consultant, Intercept: Consultant, Inventiva: Consultant, Ionis: Consultant, Janssen, Inc.: Consultant, Madrigal Pharmaceuticals: Consultant, Merck, Metacrine, Inc.: Consultant, NGM Biopharmaceuticals: Consultant, Novartis: Consultant, Novo Nordisk: Consultant, Pfizer: Consultant, Sagimet Biosciences: Consultant, Terns Pharmaceuticals: Consultant, Theratechnologies and Viking Therapeutics: Consultant, 89bio: Stock options, Sagimet Biosciences: Stock options, Arrowhead Pharmaceuticals: Research grant, AstraZeneca: Research grant, Boehringer Ingelheim: Research grant, Bristol Myers Squibb: Research grant, Eli Lilly: Research grant, Galectin Therapeutics: Research grant, Galmed Pharmaceuticals: Research grant, Gilead: Research grant, Hanmi: Research grant, Intercept: Research grant, Inventiva: Research grant, Ionis: Research grant, Janssen, Inc.: Research grant, Madrigal Pharmaceuticals: Research grant, Merck: Research grant, NGM Biopharmaceuticals: Research grant, Novo Nordisk: Research grant, Pfizer: Research grant, Sonic Incytes: Research grant, Terns Pharmaceuticals: Research grant, LipoNexus, Inc.: Co-founder, Naim Alkhouri: Madrigal: Speaking and Teaching, Novo Nordisk: Consulting, Novo Nordisk: Grant/Research Support, Corcept: Grant/Research Support, Echosens: Speaking and Teaching, Perspectum: Consultant, Cima: Consultant, Fibronostics: Consultant, 89Bio: Grant/Research Support, Inventiva: Grant/Research Support, Merck: Grant/Research Support, Pfizer: Grant/Research Support, Ipsen: Speaking and Teaching, Intercept: Speaking and Teaching, Madrigal: Consulting, Research Funding, Novo Nordisk: Consulting, Research Funding, Inventiva: Research Funding, Boehringer Ingelheim: Consulting, Research Funding, Corcept: Research Funding, Ipsen: Consulting, Research Funding, Gliead: Consulting, Research Funding, Speaking, Perspectum: Consulting, Research Funding, Cima: Advisor, 89Bio: Consulting, Research Funding, Arbutus: Grant/Research Support, GSK: Grant/Research Support, Regeneron: Grant/Research Support, AstraZeneka: Grant/Research Support, Madrigal: Grant/Research Support, Akero: Grant/Research Support, Boehringer Ingelheim: Grant/Research Support, Eli Lilly: Grant/Research Support, Gilead: Grant/Research Support, Galectin: Grant/Research Support, Boston Pharma: Grant/Research Support, Naga Chalasani: Madrigal, Eccogene, Insitro, Boston Pharma, Chugai: Consultant, Zydus, GSK, Akero, Altimmune: Consultant, Sciences: Grant/Research Support, Grant/Research Support, Merck: Consultant, Altimmune: Altimmune: Stock - publicly traded company, Altimmune: Consultant, Speaking and Teaching, Gilead: Speaking and Teaching, Speaking and Teaching, Speaking and Teaching, Madrigal: Consultant, Intercept: Speaking and Teaching, Stock – privately held company, Advisor, Altimmune: Inc.: Altimmune: IN OF IN A MULTICENTER, PHASE 2 TRIAL Rohit San of California, San and University of Clinical and Research Lilly and Background: is a once-weekly dual agonist of the and 2 study with liver were in the in and of in Methods: with BMI or BMI with were to weeks of once-weekly subcutaneous of or mg dose or placebo and and activity were and in of with and in and of with at and Results: of of or with were in analysis and were to or mg mg or mg were balanced with mean age of BMI and was in for at the primary of with in of in mg, in mg, in mg, and in in mg, in mg, in mg, and in in and was of in mg, in mg, in mg, and in at A was observed in and in weight with mg to and to to to to and to a of at were observed at weeks. Conclusion: with and in and of with the at and respectively. were with in weight and with and Rohit Loomba: Eli Lilly and Company: Consultant, 89bio: Consultant, Aardvark Therapeutics: Consultant, Altimmune: Consultant, Alnylam/Regeneron: Consultant, Amgen: Consultant, Arrowhead Pharmaceuticals: Consultant, AstraZeneca: Consultant, Bristol Myers Squibb: Consultant, CohBar: Consultant, Eli Lilly: Consultant, Galmed Pharmaceuticals: Consultant, Gilead: Consultant, Glympse Bio: Consultant, Hightide: Consultant, Inipharma: Consultant, Intercept: Consultant, Inventiva: Consultant, Ionis: Consultant, Janssen, Inc.: Consultant, Madrigal Pharmaceuticals: Consultant, Merck, Metacrine, Inc.: Consultant, NGM Biopharmaceuticals: Consultant, Novartis: Consultant, Novo Nordisk: Consultant, Pfizer: Consultant, Sagimet Biosciences: Consultant, Terns Pharmaceuticals: Consultant, Theratechnologies and Viking Therapeutics: Consultant, 89bio: Stock options, Sagimet Biosciences: Stock options, Arrowhead Pharmaceuticals: Research grant, AstraZeneca: Research grant, Boehringer Ingelheim: Research grant, Bristol Myers Squibb: Research grant, Eli Lilly: Research grant, Galectin Therapeutics: Research grant, Galmed Pharmaceuticals: Research grant, Gilead: Research grant, Hanmi: Research grant, Intercept: Research grant, Inventiva: Research grant, Ionis: Research grant, Janssen, Inc.: Research grant, Madrigal Pharmaceuticals: Research grant, Merck: Research grant, NGM Biopharmaceuticals: Research grant, Novo Nordisk: Research grant, Pfizer: Research grant, Sonic Incytes: Research grant, Terns Pharmaceuticals: Research grant, LipoNexus, Inc.: Co-founder, Inc.: Grant/Research Support, Inc.: Grant/Research Support, Grant/Research Support, Boehringer Ingelheim: Grant/Research Support, Inc.: Grant/Research Support, Inc.: Grant/Research Support, Inc.: Grant/Research Support, Inc.: Grant/Research Support, Pharmaceuticals: Grant/Research Support, Research Inc.: Grant/Research Support, Eli Lilly Grant/Research Support, Madrigal Inc.: Grant/Research Support, Grant/Research Support, Consultant, Inc.: Grant/Research Support, Grant/Research Support, Novo Grant/Research Support, Inc.: Grant/Research Support, Inc.: Grant/Research Support, Inc.: Grant/Research Support, Inc.: Grant/Research Support, Viking Inc.: Grant/Research Support, Grant/Research Support, Zydus Inc.: Grant/Research Support, or Boehringer Ingelheim: Consultant, Boehringer Ingelheim: Grant/Research Support, Grant/Research Support, Madrigal: Grant/Research Support, Lilly: Consultant, Novo Nordisk: Consultant, Amgen: Consultant, Pfizer: Consultant, Lilly: Grant/Research Support, Novo Nordisk: Grant/Research Support, Amgen: Grant/Research Support, Pfizer: Grant/Research Support, Eli Lilly and to San Eli Lilly and Company: Eli Lilly and Company: Eli Lilly and Company: Eli Lilly and Company: Eli Lilly and Company: Stock – privately held company, Lilly: Eli Lilly and Company: IN TRIAL of Medical of of of Background: and for patients with a to Methods: a were at in the and in with and without were randomized to receive or and stage 2 were randomized to or and The primary was a of and study an with Results: A of female, with and of The of vs. or to and or the of the primary to (95% of had a of (95% and had a (95% 24 the of the primary (95% CI, and (95% was in adverse events treatment Conclusion: and to and for patients with and is the trial of and the trial of for patients with Madrigal: Grant/Research Support, to Consultant, Consultant, Consultant, Novo Nordisk: Advisor, Amgen: Consultant, Consultant, Consultant, to to Grant/Research Support, Grant/Research Support, Grant/Research PHASE 2 OF A IN METABOLIC IN Mazen 1Houston Methodist Clinical Research Background: MASH is a in the of metabolic and is a dual GLP-1/glucagon receptor agonist for the treatment of The results of and Methods: The study is an ongoing randomized, placebo-controlled, double-blind 2 study had liver and metabolic or liver biopsy with at in and fibrosis of were randomized to receive subcutaneous mg or placebo with mg for the 2 weeks. The primary was liver at weeks. Results: A of were randomized to the group or to the placebo group. A had The primary was at the of liver was in the group placebo p<0.0001). A of patients in the group and liver placebo and 0%, for the liver to in placebo a in liver to placebo was a in in the group placebo led to a in weight at and 24 weeks and placebo and for led to a in liver and was adverse events were which led to of in the group. Conclusion: The study primary and significant in liver at weeks. led to in of and weight with at 24 Mazen Noureddin: ltimmune, BI, Cytodyn, 89BIO, GSK, Madrigal, Merck, Novo Nor: Terns,Takeda, Zydus., Allergan, Akero, BI, BMS, Gilead, Galectin, Zydus GSK: Terns, Corcept, Takeda, Madrigal, Novartis, Novo Nordisk, Rivus Pharma, Cytodyn, and ChronWell: Stock – privately held company, Altimmune: Consultant, Alligos: Consultant, AstraZeneca: Consultant, BI: Consultant, Boston Pharmaceuticals: Consultant, Cytodyn: Consultant, GSK: Consultant, Eli Lilly: Consultant, Madrigal: Consultant, Merck: Consultant, Novo Nordisk: Consultant, Terns: Consultant, Takeda: Consultant, Allergan: Principal Investigator for a Drug Study, Akero: Principal Investigator for a Drug Study, BI: Principal Investigator for a Drug Study, BMS: Principal Investigator for a Drug Study, Gilead: Principal Investigator for a Drug Study, Galectin: Principal Investigator for a Drug Study, Genfit: Principal Investigator for a Drug Study, GSK: Principal Investigator for a Drug Study, Conatus: Principal Investigator for a Drug Study, Corcept: Principal Investigator for a Drug Study, Enanta: Principal Investigator for a Drug Study, Madrigal: Principal Investigator for a Drug Study, Novartis: Principal Investigator for a Drug Study, Novo Nordisk: Principal Investigator for a Drug Study, Shire: Principal Investigator for a Drug Study, Takeda: Principal Investigator for a Drug Study, Terns: Principal Investigator for a Drug Study, Viking: Principal Investigator for a Drug Study, Zydus: Principal Investigator for a Drug Study, Rivus Pharmaceuticals: Stock – privately held company, Cytodyn: Stock - publicly traded company, ChronWell: Stock – privately held company, Madrigal: Speaking and Teaching, Akero: Stock – privately held company, Akero: Advisor, Alligos: Advisor, Altimmune: Advisor, AstraZeneca: Advisor, Boehringer Ingelheim: Advisor, Boston Pharma: Advisor, Cytodyn: Advisor, GSK: Advisor, Lilly: Advisor, Madrigal: Advisor, Merck: Advisor, Novo Nordisk: Advisor, Sagimet: Advisor, Terns: Advisor, Takeda: Advisor, Akero: Principal Investigator, Allergan: Principal Investigator, Altimmune: Principal Investigator, Boehringer Ingelheim: Principal Investigator, Bristol Myers Squibb: Principal Investigator, Boston Pharma: Principal Investigator, Conatus: Principal Investigator, Corcept: Principal Investigator, Galectin: Principal Investigator, Genfit: Principal Investigator, GSK: Principal Investigator, Kowa: Principal Investigator, Enanta: Principal Investigator, Madrigal: Principal Investigator, Lilly: Principal Investigator, Merck: Principal Investigator, Novartis: Principal Investigator, Novo Nordisk: Principal Investigator, Rivus: Principal Investigator, Shire: Principal Investigator, Takeda: Principal Investigator, Terns: Principal Investigator, Viking: Principal Investigator, Zydus: Principal Investigator, Rivus: Stock – privately held company, Cytodyn: Stock - publicly traded company, ChronWell: Stock – privately held company, Madrigal: Speakers bureau, Conatus: Principal Investigator, Gilead Sciences: Principal Investigator, Akero: Consultant, Altimmune: Consultant, Alligos: Consultant, AstraZeneca: Consultant, BI: Consultant, Boston Pharma: Consultant, Curve bioscience: Consultant, Cytodyn: Consultant, GSK: Consultant, Histoindex: Consultant, Lilly: Consultant, Madrigal: Consultant, Merck: Consultant, Novo Nordisk: Consultant, Rivus, Sagimet: Consultant, Rivus: Consultant, Sagimet: Consultant, Terns: Consultant, Allergan: Grant/Research Support, Altimmune: Grant/Research Support, Akero: Grant/Research Support, BI: Grant/Research Support, BMS: Grant/Research Support, Boston Pharma: Grant/Research Support, Conatus: Grant/Research Support, Corcept: Grant/Research Support, Gilead: Grant/Research Support, Galectin: Grant/Research Support, Genfit: Grant/Research Support, GSK: Grant/Research Support, Kowa: Grant/Research Support, Enanta: Grant/Research Support, Madrigal: Grant/Research Support, Lilly: Grant/Research Support, Merck: Grant/Research Support, Novartis: Grant/Research Support, Novo Nordisk: Grant/Research Support, Rivus: Grant/Research Support, Shire: Grant/Research Support, Takeda: Grant/Research Support, Terns: Grant/Research Support, Viking: Grant/Research Support, Rivus Pharma: Stock – privately held company, Akero: Stock - publicly traded company, Zydus: Grant/Research Support, Takeda: Consultant, Madrigal: Speaking and Teaching, Novo Nordisk: Speaking and Teaching, Takeda: Consultant, Therapeutics: Grant/Research Support, Altimmune: Grant/Research Support, 89Bio: Grant/Research Support, Boehringer Ingelheim: Grant/Research Support, Boston Pharmaceuticals: Grant/Research Support, Eli Lilly: Grant/Research Support, Grant/Research Support, Inventiva: Grant/Research Support, Madrigal Pharmaceuticals: Grant/Research Support, Madrigal Pharmaceuticals: Speaking and Teaching, Merck: Grant/Research Support, Novo Nordisk: Grant/Research Support, Novo Nordisk: Consultant, Galectin Therapeutics: Grant/Research Support, Pharmaceuticals: Grant/Research Support, Grant/Research Support, Therapeutics: Grant/Research Support, Boehringer Ingelheim: Consultant, Novo Nordisk: Speaking and Teaching, to Rohit to Inc.: Inc.: IN A PHASE 2 PLACEBO-CONTROLLED TRIAL Mazen 1Houston Research Methodist University Background: is a metabolic in development for the treatment of and Phase 2 study the of in liver and metabolic in with Methods: patients were randomized to receive placebo or at or for weeks in a of The study patients with MASH with a of patients with fibrosis and an The primary was in liver endpoints liver of in and of metabolic The primary analysis the with missing data a placebo Results: the primary was liver in patients mean for of mg, for placebo for A liver in the of and for of mg, with placebo for of and mg weight placebo was with for subcutaneous at the with in or was and well consistent with results of Phase 2 Conclusion: with in liver and a and significant of in patients with development of for Mazen Noureddin: ltimmune, BI, Cytodyn, 89BIO, GSK, Madrigal, Merck, Novo Nor: Terns,Takeda, Zydus., Allergan, Akero, BI, BMS, Gilead, Galectin, Zydus GSK: Terns, Corcept, Takeda, Madrigal, Novartis, Novo Nordisk, Rivus Pharma, Cytodyn, and ChronWell: Stock – privately held company, Altimmune: Consultant, Alligos: Consultant, AstraZeneca: Consultant, BI: Consultant, Boston Pharmaceuticals: Consultant, Cytodyn: Consultant, GSK: Consultant, Eli Lilly: Consultant, Madrigal: Consultant, Merck: Consultant, Novo Nordisk: Consultant, Terns: Consultant, Takeda: Consultant, Allergan: Principal Investigator for a Drug Study, Akero: Principal Investigator for a Drug Study, BI: Principal Investigator for a Drug Study, BMS: Principal Investigator for a Drug Study, Gilead: Principal Investigator for a Drug Study, Galectin: Principal Investigator for a Drug Study, Genfit: Principal Investigator for a Drug Study, GSK: Principal Investigator for a Drug Study, Conatus: Principal Investigator for a Drug Study, Corcept: Principal Investigator for a Drug Study, Enanta: Principal Investigator for a Drug Study, Madrigal: Principal Investigator for a Drug Study, Novartis: Principal Investigator for a Drug Study, Novo Nordisk: Principal Investigator for a Drug Study, Shire: Principal Investigator for a Drug Study, Takeda: Principal Investigator for a Drug Study, Terns: Principal Investigator for a Drug Study, Viking: Principal Investigator for a Drug Study, Zydus: Principal Investigator for a Drug Study, Rivus Pharmaceuticals: Stock – privately held company, Cytodyn: Stock - publicly traded company, ChronWell: Stock – privately held company, Madrigal: Speaking and Teaching, Akero: Stock – privately held company, Akero: Advisor, Alligos: Advisor, Altimmune: Advisor, AstraZeneca: Advisor, Boehringer Ingelheim: Advisor, Boston Pharma: Advisor, Cytodyn: Advisor, GSK: Advisor, Lilly: Advisor, Madrigal: Advisor, Merck: Advisor, Novo Nordisk: Advisor, Sagimet: Advisor, Terns: Advisor, Takeda: Advisor, Akero: Principal Investigator, Allergan: Principal Investigator, Altimmune: Principal Investigator, Boehringer Ingelheim: Principal Investigator, Bristol Myers Squibb: Principal Investigator, Boston Pharma: Principal Investigator, Conatus: Principal Investigator, Corcept: Principal Investigator, Galectin: Principal Investigator, Genfit: Principal Investigator, GSK: Principal Investigator, Kowa: Principal Investigator, Enanta: Principal Investigator, Madrigal: Principal Investigator, Lilly: Principal Investigator, Merck: Principal Investigator, Novartis: Principal Investigator, Novo Nordisk: Principal Investigator, Rivus: Principal Investigator, Shire: Principal Investigator, Takeda: Principal Investigator, Terns: Principal Investigator, Viking: Principal Investigator, Zydus: Principal Investigator, Rivus: Stock – privately held company, Cytodyn: Stock - publicly traded company, ChronWell: Stock – privately held company, Madrigal: Speakers bureau, Conatus: Principal Investigator, Gilead Sciences: Principal Investigator, Akero: Consultant, Altimmune: Consultant, Alligos: Consultant, AstraZeneca: Consultant, BI: Consultant, Boston Pharma: Consultant, Curve bioscience: Consultant, Cytodyn: Consultant, GSK: Consultant, Histoindex: Consultant, Lilly: Consultant, Madrigal: Consultant, Merck: Consultant, Novo Nordisk: Consultant, Rivus, Sagimet: Consultant, Rivus: Consultant, Sagimet: Consultant, Terns: Consultant, Allergan: Grant/Research Support, Altimmune: Grant/Research Support, Akero: Grant/Research Support, BI: Grant/Research Support, BMS: Grant/Research Support, Boston Pharma: Grant/Research Support, Conatus: Grant/Research Support, Corcept: Grant/Research Support, Gilead: Grant/Research Support, Galectin: Grant/Research Support, Genfit: Grant/Research Support, GSK: Grant/Research Support, Kowa: Grant/Research Support, Enanta: Grant/Research Support, Madrigal: Grant/Research Support, Lilly: Grant/Research Support, Merck: Grant/Research Support, Novartis: Grant/Research Support, Novo Nordisk: Grant/Research Support, Rivus: Grant/Research Support, Shire: Grant/Research Support, Takeda: Grant/Research Support, Terns: Grant/Research Support, Viking: Grant/Research Support, Rivus Pharma: Stock – privately held company, Akero: Stock - publicly traded company, Zydus: Grant/Research Support, Takeda: Consultant, Madrigal: Speaking and Teaching, Novo Nordisk: Speaking and Teaching, Takeda: Consultant, Rivus Pharmaceuticals: Stock - publicly traded company, Terns Consultant, Boehringer Lilly Consultant, Novo Nordisk: Consultant, Consultant, Consultant, Consultant, Consultant, Arrowhead Consultant, Zydus Boston Consultant, Consultant, Gilead, Bristol Merck, Novartis: or Bio: Histoindex: Advisor, Consultant, Consultant, Consultant, Advisor, Takeda: Consultant, Eli Lilly: Advisor, 89Bio: Advisor, Boston Pharma: Advisor, GSK: Advisor, Akero: Advisor, Eli Consultant, Corcept, Boston Consultant, Regeneron: Consultant, Boehringer Bristol Myers Gilead: Consultant, Janssen, Madrigal, Merck, Consultant, Akero, Novo Nordisk, Consultant, Consultant, Takeda, Terns, Zydus: Consultant, Bristol Myers Gilead, Intercept: Merck, Novartis, or Stock – privately held TRIAL IN Medical of University Clinical of The University of of and Clinical of University of Bristol Background: is a of in patients with and to an of primary to a in without primary to in patients is Methods: a placebo-controlled, trial patients with and treatment or and or of were in a to receive mg or an placebo for 18 were with a of and a of 18 The primary was Results: patients at 41 in and with alcohol the of in patients to and to placebo were in the to were at with in and in placebo, (95% for at use of liver disease due to alcohol and alcohol was (95% was in trial treatment and in to of analyses of the patients to an a in Conclusion: the trial of primary for patients with and use of had effect the of results primary GSK: Advisor, to to Pharma: Speaking and Teaching, Pharma: Speaking and Teaching, Ipsen: Speaking and Teaching, Gilead: Speaking and Teaching, Pharma: Speaking and Teaching, Pharma: Speaking and Teaching, to to to to Advisor, Advisor, Gilead: Advisor, Regeneron: Advisor, Advisor, to to Advisor, GSK: Advisor, to Gilead: Speaking and Teaching, Ipsen: Speaking and Teaching, to Novo Nordisk: Consultant, to OF IN RANDOMIZED, PHASE for and of Medical University of Medical of Background: is a the of the of and to a in and in patients with is in a Phase study for treatment of Here, we the treatment ongoing Methods: patients with were and and randomized in a dose or mg for weeks a with and a group only for weeks without The primary a is the of patients at the of or a of 2 with endpoints the at the of and at weeks 24 and in and and in liver Results: A of patients with were in the analysis in group, in the group, and in the group. were balanced with a mean age of with mean and mean The at 24 were for the group and for the group, to and at which were in the group. in and liver in the were in the group. was and without adverse events to or to Conclusion: and in with results observed in both dose to to to to to to to to to to to to to to to to to OF IN IN PHASE TRIAL University of Medical University of Medical Medical University of and Background: and disease of an disease results in and of is an results in and is a randomized, placebo Phase trial the and of a treatment for Methods: A analysis of trial results was to and in who had disease activity in the or had a of at 2 and had an treatment the were randomized to or and were and of the randomized were to at the of for was the Results: had of the of the and study disease activity was in the and liver in and respectively. the of of the to in the group the group, and a the liver group, and a The of were with vs. and for the and groups, use was with vs. in the and to in and in in 1). Conclusion: of patients with in and of were in trial Speaking and Teaching, Advisor, Advisor, Advisor, GSK: Speaking and Teaching, Pharma: Advisor, Speaking and Teaching, Intercept: Speaking and Teaching, Grant/Research Support, Speaking and Teaching, Amgen: to Amgen: Amgen: OF A IN of Medical of Medical of Medical Medical of University Medical of and Background: is a of despite and a and in early of Here, we the and with a to for Methods: is a study in the with or and was 30 was of or or was The was a The primary were to in a to with of and The was to for Results: were The were and were of which were for was for 1). was for for and for and were and respectively. were and respectively. Conclusion: for to a the of to and an to the of in Sciences: Grant/Research Support, Grant/Research Support, Grant/Research Support, Gilead: Grant/Research Support, Consultant, Takeda: Grant/Research Support, Consultant, Consultant, Consultant, Sciences: Takeda: Madrigal: Advisor, Consultant, AstraZeneca: Consultant, Consultant, Consultant, Consultant, Merck: Consultant, Consultant, Medical Sciences: Consultant, Sciences: Consultant, Consultant, Boston Consultant, Consultant, Consultant, Consultant, Consultant, Consultant, Curve Biosciences: Consultant, Consultant, Consultant, Grant/Research Support, Grant/Research Support, Consultant, AstraZeneca: Consultant, Sciences: Grant/Research Support, Sciences: Consultant, Advisor, Sciences: Consultant, AstraZeneca: Consultant, Consultant, Consultant, Medical Sciences: Consultant, Advisor, Grant/Research Support, Advisor, Grant/Research Support, Boston Grant/Research Support, Advisor, Sciences: Advisor, Sciences: Grant/Research Support, Medical Speaking and Teaching, Medical Grant/Research Support, Grant/Research Support, Gilead Sciences: Advisor, Gilead Sciences: Grant/Research Support, Grant/Research Support, Advisor, Grant/Research Support, Pharmaceuticals: Consultant, Grant/Research Support, Speaking and Teaching, Speaking and Teaching, Consultant, Grant/Research Support, Consultant, - Consultant, Grant/Research Support, Grant/Research Support, Grant/Research Support, Naga Chalasani: Madrigal, Eccogene, Insitro, Boston Pharma, Chugai: Consultant, Zydus, GSK, Akero, Altimmune: Consultant, Sciences: Grant/Research Support, Grant/Research Support, Merck: Consultant, Speaking and Teaching, AstraZeneca: Advisor, Speaking and Teaching, Sciences: and Sciences: Sciences: Stock - publicly traded company, Sciences: to Sciences: Sciences: Stock - publicly traded company, Sciences: Sciences: Stock - publicly traded OF A IN – PHASE 2 TRIAL Medical of of of Medical Medical Medical University Background: is a and and in and and in a Phase Phase 2 data Here, we results the Phase 2 Methods: randomized, Phase 2 study and of in and 2 2 30 mg or mg for 30 mg for weeks. patients for with and and The primary was in the of the endpoints in and Results: The 30 mg the with mean of at 85 placebo The in is of the patients in group was well tolerated with or adverse events were or were observed in or Conclusion: and activity in with the effect in the results or in with a of to IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS A PHASE 2, Mazen 1Houston Methodist Research of of of California, San San Background: a significant and liver and with a well-tolerated in a randomized, 2 study in with biopsy-confirmed the of and of mg weeks in with to weeks Methods: the study were for the and for to 24 weeks The primary was and with and in non-invasive of liver liver and Results: in the with to weeks of and biopsies or fibrosis improvement ≥1 stage without worsening of MASH was in MASH resolution without fibrosis in of and both fibrosis improvement ≥1 stage and MASH in fibrosis and liver were observed with mean of in in and in of with in to consistent with for 24 weeks was well-tolerated of study with to adverse events were or with events and and the 24 weeks of treatment. the was and discontinued due to Conclusion: in fibrosis improvement and MASH resolution, and with a well-tolerated in with to weeks of Phase in to a treatment for Mazen Noureddin: ltimmune, BI, Cytodyn, 89BIO, GSK, Madrigal, Merck, Novo Nor: Terns,Takeda, Zydus., Allergan, Akero, BI, BMS, Gilead, Galectin, Zydus GSK: Terns, Corcept, Takeda, Madrigal, Novartis, Novo Nordisk, Rivus Pharma, Cytodyn, and ChronWell: Stock – privately held company, Altimmune: Consultant, Alligos: Consultant, AstraZeneca: Consultant, BI: Consultant, Boston Pharmaceuticals: Consultant, Cytodyn: Consultant, GSK: Consultant, Eli Lilly: Consultant, Madrigal: Consultant, Merck: Consultant, Novo Nordisk: Consultant, Terns: Consultant, Takeda: Consultant, Allergan: Principal Investigator for a Drug Study, Akero: Principal Investigator for a Drug Study, BI: Principal Investigator for a Drug Study, BMS: Principal Investigator for a Drug Study, Gilead: Principal Investigator for a Drug Study, Galectin: Principal Investigator for a Drug Study, Genfit: Principal Investigator for a Drug Study, GSK: Principal Investigator for a Drug Study, Conatus: Principal Investigator for a Drug Study, Corcept: Principal Investigator for a Drug Study, Enanta: Principal Investigator for a Drug Study, Madrigal: Principal Investigator for a Drug Study, Novartis: Principal Investigator for a Drug Study, Novo Nordisk: Principal Investigator for a Drug Study, Shire: Principal Investigator for a Drug Study, Takeda: Principal Investigator for a Drug Study, Terns: Principal Investigator for a Drug Study, Viking: Principal Investigator for a Drug Study, Zydus: Principal Investigator for a