A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults with Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis - MK-6024-017

Start Date02 Oct 2024

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT06482112

/ Active, not recruitingPhase 2

A Phase 2a Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Different Dosing Regimens of Efinopegdutide (MK-6024) in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease

This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.

Start Date29 Jul 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06465186

/ RecruitingPhase 2

Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis

Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn:
* If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver
* About the safety of efinopegdutide and how well people tolerate it

Start Date12 Jul 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Efinopegdutide

100 Translational Medicine associated with Efinopegdutide

100 Patents (Medical) associated with Efinopegdutide

Literatures (Medical) associated with Efinopegdutide

07 Dec 2024·Cureus Journal of Medical Science

Comparative Efficacy of Semaglutide Versus Liraglutide or Efinopegdutide on Weight Loss in Obese Patients: A Systematic Review and Meta-Analysis

Review

Author: Akhtar, Muzammil ; Bernstein, Ethan M ; Puglisi, Jose ; Nadora, Denise ; How-Volkman, Christiane ; Wen, Jimmy ; Frezza, Eldo ; Truong, Alina

Glucagon-like peptide-1 agonists (GLP-1 RAs) have produced substantial weight loss effects in type 2 diabetes mellitus (T2DM) cohorts, but these effects have not been thoroughly studied in patients with obesity and without diabetes. This review aimed to analyze direct comparative studies for semaglutide versus other GLP-1 RA (liraglutide and efinopegdutide) in facilitating weight loss and evaluating adverse events in patients with obesity. A systematic search following the guidelines established by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was performed in PubMed, Embase, and Cochrane Library for direct comparative studies comparing semaglutide with other GLP-1 RA on weight loss in patients with obesity. A narrative synthesis and meta-analysis were performed to analyze the differences in weight loss between cohorts. A meta-analysis found that semaglutide produced a greater effect on mean weight loss compared to liraglutide, but did not produce a significant difference compared to efinopegdutide. Semaglutide, liraglutide, and efinopegdutide were well-tolerated and were associated with primarily minimal to moderate severity adverse effects, most of which were gastrointestinal. Future studies should continue to focus on conducting direct comparisons between GLP-1 RAs and emerging multi-receptor GLP-1 RAs, such as efinopegdutide, tirzepatide, and retratrutide, to determine clinical efficacy, long-term safety, and identifying the most effective regimens for clinical practice.

01 Oct 2024·ANALYTICAL BIOCHEMISTRY

Implementation of a LC-MS based multi-attribute method (MAM) and intact multi-attribute method (iMAM) workflow for the characterisation of a GLP-Fc fusion protein

Article

Author: Bones, Jonathan ; MacHale, Ciara ; Buckley, Ciarán ; Millán-Martín, Silvia ; Füssl, Florian ; Carillo, Sara

Over the past few years, the implementation of mass spectrometry (MS) in QC laboratories has become a more common occurrence. The multi-attribute method (MAM), and emerging intact multi-attribute method (iMAM), are powerful analytical tools utilising liquid chromatography-mass spectrometry (LC-MS) methods that enable the monitoring of critical quality attributes (CQAs) in biotherapeutic proteins in compliant settings. Both MAM and iMAM are intended to replace or supplement several conventional assays with a single LC-MS method utilising MS data in combination with robust, semi-automated data processing workflows. MAM and iMAM workflows can also be implemented into current Good Manufacturing Practices environments due to the availability of CFR 11 compliant chromatography data system software. In this study, MAM and iMAM are employed for the analysis of 4 batches of a glucagon-like peptide-Fc fusion protein. MAM approach involved a first the discovery phase for the identification of CQAs and second, the target monitoring phase of the selected CQAs in other samples. New peak detection was performed on the data set to determine the appearance, absence or change of any peak. For native iMAM workflow both size exclusion and strong cation exchange chromatography were optimized for the identification and monitoring of CQAs at the intact level.

25 Jun 2024·JOURNAL OF ENDOCRINOLOGY

Gut hormone multi-agonists for the treatment of type 2 diabetes and obesity: advances and challenges

Review

Author: Zhou, Zhongbo ; Jiang, Neng ; Liu, Jing ; Peng, Guangquan ; Huang, Xianxian ; Yan, Zhiming ; Lu, Mingyue

The rapidly rising incidence of obesity, coupled with type 2 diabetes mellitus (T2DM), is a growing concern. Glucagon-like peptide 1 (GLP-1), an endogenous peptide secreted by enteroendocrine L-cells, demonstrates exceptional pharmacological potential for the treatment of T2DM and obesity, primarily through its pivotal roles in regulating glucose homeostasis, stimulating glucose-dependent insulin secretion, and promoting satiety. Considering its proven efficacy in glucoregulation and weight loss, GLP-1 receptor agonists (GLP-1RAs) have emerged as a revolutionary breakthrough in the arena of diabetes management and weight control. Additional gastrointestinal hormones, such as glucose-dependent insulinotropic peptide (GIP) and glucagon, exhibit structural similarities to GLP-1 and work synergistically to lower blood glucose levels or aid in weight loss. Today, various classes of gut hormone receptor multiple agonists are steadily progressing through development and clinical trials, including dual GLP-1/glucagon receptor agonists (first discovered in 2009), dual GLP-1/GIP receptor agonists (first described in 2013), and triple GLP-1/GIP/glucagon receptor agonists (initially designed in 2015). The GLP-1/GIP receptor co-agonist, tirzepatide, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of T2DM, outperforming basal insulin or selective GLP-1RAs by providing superior HbA1c reductions. Remarkably, tirzepatide also facilitated unprecedented weight loss of up to 22.5% in non-diabetic individuals living with obesity. This result is comparable to those achieved with certain types of bariatric surgery. Therefore, the advent of gut hormone multi-agonists signifies the dawn of an exciting new era in peptide-based therapy for obesity and T2DM. This review offers a comprehensive summary of the various types of gut hormone multiple agonists, including their discovery, development, action of mechanisms, and clinical effectiveness. We further delve into potential hurdles, limitations, and prospective advancements in the field.

News (Medical) associated with Efinopegdutide

17 Mar 2025

·www.fiercebiotech.com

Opko, Entera share ownership of first oral GLP-1/glucagon agonist set to enter clinic

Opko Health said a planned phase 1 study would mark the first time that an orally administered GLP-1/glucagon agonist would enter human trials.\n Opko Health and Entera Bio have formalized their partnership as the biotechs prepare to take the first orally administered dual agonist glucagonlike-peptide 1 (GLP-1)/glucagon peptide into the clinic.The once-daily pill combines Opko’s long-acting GLP-1/glucagon dual agonist peptide, dubbed OPK-88006, with Entera’s N-Tab oral delivery tech. The companies’ current timetable would involve seeking permission from the FDA “later this year” to enter human trials, according to a March 17 release.The agreement will see Miami-based Opko and Israel-based Entera holding 60% and 40% ownership, respectively, in the program, and sharing the development costs by the same ratio.Opko will also buy 3.6 million shares of Entera at $2.17 a pop, slightly above the $1.88 price at which the shares closed after Friday’s trading. Entera will use the proceeds to help fund its side of the development costs through to the phase 1 trial.Beyond that first human study, Entera will then have the option to continue to fund its side of the development in order to retain its part of the program’s ownership. If the biotech decides at this point to opt out, it will still keep a 15% ownership interest, with Opko accounting for the remaining 85% while taking on the full development and funding burden.The two blockbuster obesity drugs already on the market are Novo Nordisk’s GLP-1 agonist Wegovy and Eli Lilly’s dual GLP-1/GIP agonist Zepbound. However, there are not yet any approved therapies that follow Opko’s modality of simultaneously activating the GLP-1 and glucagon receptors.Big Pharmas have tended to evaluate dual GLP-1/glucagon co-agonists as potential treatments for metabolic dysfunction-associated steatohepatitis (MASH). AstraZeneca has its own candidate, dubbed AZD9550, in phase 1 development for the liver condition, while Merck & Co.’s efinopegdutide beat Wegovy in the related condition of nonalcoholic fatty liver disease in a phase 2 trial.Opko said taking their drug into the clinic this year would mark the first time an orally administered GLP-1/glucagon agonist would enter human trials. The hope is that the med can be used as a once-daily table treatment for patients with obesity as well as metabolic and fibrotic disorders. Opko and Entera have already been collaborating on the obesity drug as well as on an oral GLP-2 peptide tablet they hope will offer an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome.“We are pleased to continue working with Entera on this promising program to develop the first oral GLP-1/glucagon dual agonist in addition to our subcutaneous injectable dual agonist GLP-1/glucagon program,” Onko’s CEO Phillip Frost, M.D., said in the release. “Our goal with this franchise is to provide additional options for patients with obesity, metabolic and fibrotic diseases.”

Phase 2License out/inPhase 1

05 Feb 2025

·www.businesswire.com

AgelessRx Expands Offerings to Include Oral GLP-1 Drops to Advance Metabolic Health and Longevity Science

ANN ARBOR, Mich.--( BUSINESS WIRE )-- AgelessRx , a pioneer in longevity and telehealth solutions, announced the introduction of oral sublingual drops for GLP-1 receptor agonists Semaglutide and Tirzepatide. By offering non-injectable alternatives to medications that may support metabolic health management 1 and counter the effects of aging 2 , AgelessRx continues to empower individuals to live longer, healthier lives. Optimal metabolic health is a foundational component of longevity. Dysregulated glucose levels, visceral fat accumulation, and other markers of poor metabolic function accelerate biological aging and increase the risk of chronic diseases, such as cardiovascular disease, Type 2 diabetes, and liver disease, making GLP-1s critical for overall health and healthspan. “Our mission is to make longevity accessible for all, and GLP-1s are a core piece of that puzzle,” said Stefanie Morgan, Vice President of Applied Sciences at AgelessRx. “The impact of these medications is proving to go beyond traditional uses to significantly improve key health metrics - from metabolic health, to glucose regulation, liver function 34 , heart health, and even sleep 56 - that could be foundational to a long, healthy life and a key driver in longevity.” Recent research shows that about one in eight adults have taken a GLP-1 in their lifetime. Unlike conventional approaches, these medications may do more than manage symptoms - they may work at a biological level to support overall health. These benefits directly contribute to increased healthspan by potentially delaying the onset of chronic diseases and supporting cellular resilience. Compounded with a SubMagna SL HMW, AgelessRx’s sublingual methods bypass digestion for quicker, more efficient delivery into the bloodstream as compared to other oral methods such as digestible tablets. As a longevity-focused telehealth platform, AgelessRx’s Stanford PhD-led Applied Sciences team is actively exploring the broader applications of GLP-1s in promoting lifespan and longevity. The introduction of oral GLP-1s reflects the company’s dedication to the core principles of longevity - prevention of chronic conditions through better metabolic control, personalization of care to meet individual health needs, and proactivity in empowering individuals to take charge of their long-term well-being. By making these transformative therapies more accessible and adaptable to individual needs, AgelessRx is helping to bring longevity-focused care within reach for millions. For additional information about AgelessRx and its longevity-promoting products and services, please visit agelessrx.com . Discover more about the benefits and details of Oral Tirzepatide Drops and Oral Semaglutide Drops through the links provided. About AgelessRx AgelessRx is at the forefront of the longevity revolution, offering clinically validated cutting-edge solutions and preventive treatments aimed at extending life expectancy and enhancing quality of life. AgelessRx also continues to advance the field of longevity science by conducting ongoing research and clinical trials . Through its online platform, AgelessRx provides easy access to innovative healthcare services, with an emphasis on customer satisfaction, affordability, and the pursuit of a future where extended healthspan is a reality for everyone. Follow AgelessRx on Instagram , X , and Facebook . ___________________ 1 MacDonald, P. E. et al. The multiple actions of GLP-1 on the process of glucose-stimulated insulin secretion. Diabetes 51, S434–442 (2002). 2 SGLT2 inhibitors and GLP-1 receptor agonists: which is the best anti-frailty drug? Mone, Pasquale et al. The Lancet Healthy Longevity, Volume 5, Issue 9, 100632 3 Targher, G., Mantovani, A. & Byrne, C. D. Mechanisms and possible hepatoprotective effects of glucagon-like peptide-1 receptor agonists and other incretin receptor agonists in non-alcoholic fatty liver disease. Lancet Gastroenterol. Hepatol. 8, 179–191 (2023). 4 Romero-Gómez, M. et al. A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease. J. Hepatol. 79, 888–897 (2023). 5 de Lemos, J. A. et al. Tirzepatide reduces 24-hour ambulatory blood pressure in adults with body mass index ≥27 kg/m(2): SURMOUNT-1 ambulatory blood pressure monitoring substudy. Hypertension 81, e41–e43 (2024). 6 Malhotra A, Grunstein RR, Fietze I, Weaver TE, Redline S, Azarbarzin A, Sands SA, Schwab RJ, Dunn JP, Chakladar S, Bunck MC, Bednarik J; SURMOUNT-OSA Investigators. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024 Oct 3;391(13):1193-1205. doi: 10.1056/NEJMoa2404881.

Phase 2

30 Jan 2025

·www.prnewswire.com

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NAFLD companies, including BeiGene, Inventiva Pharma, Cirius Therapeutics, Madrigal Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr. Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, Poxel SA, AngioLab, Pfizer, Oramed Pharmaceuticals, Can Fite Biopharma, MediciNova, Metacrine, Inc., Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Enanta Pharmaceuticals, Cascade Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

100 Deals associated with Efinopegdutide

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KEGG	Wiki	ATC	Drug Bank
D11607	-	-	DB15077

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Liver Cirrhosis	Phase 2	United States	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Japan	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Australia	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Canada	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Colombia	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	France	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Israel	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Puerto Rico	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Spain	Merck Sharp & Dohme LLC	12 Jul 2024
Liver Cirrhosis	Phase 2	Thailand	Merck Sharp & Dohme LLC	12 Jul 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04944992 (EudraCT: 2020-005136-30 \| ###DELETE \| MK-6024-001 \| 6024-001, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	145	Efinopegdutide 20 mg/mL (Efinopegdutide)	ussbbzefmo(asxgijszwk) = qwizkgigwh rauxvbxttz (evernfmovr, vlxgwbtumt - qfbolualvi) View more	-	15 Nov 2023
				Semaglutide 1.34 mg/mL (Semaglutide)	ussbbzefmo(asxgijszwk) = tawztrofsx rauxvbxttz (evernfmovr, etgtymjmwy - bsvxiibsek) View more
AASLD2023	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	145	Efinopegdutide 10 mg QW	iampwtwwpc(otmeicsdee) = pwjthihkwd qkgyzyzprx (axggqpfdre ) View more	-	10 Nov 2023
				Semaglutide 1.0 mg QW	iampwtwwpc(otmeicsdee) = hvwkusadtq qkgyzyzprx (axggqpfdre ) View more
EUCTR2020-005136-30-ES \| NCT04944992 (EASD2023)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic dysfunction-associated steatotic liver disease	145	Efinopegdutide 10 mg	divdhccxpx(lsagrcaiyk) = erzzsthcyx qfaedomalp (lbaxpuzkqf, 57.2 - 76.3) View more	Positive	04 Oct 2023
				Semaglutide 1 mg	divdhccxpx(lsagrcaiyk) = xpargqclse qfaedomalp (lbaxpuzkqf, 36.0 - 55.1) View more
EUCTR2020-005136-30-ES \| NCT04944992 (Pubmed)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	145	Efinopegdutide 10 mg	sawgmrmqrf(kefguvxkgp) = tivfseqwyt qalxnwdomt (mdxlnygyfv, 66.8 - 78.7) View more	Positive	01 Oct 2023
				Semaglutide 1 mg	sawgmrmqrf(kefguvxkgp) = pxgcdksyqm qalxnwdomt (mdxlnygyfv, 36.5 - 48.1) View more
NCT03486392 (CTgov)	Phase 2	Obesity	474	placebo+JNJ-64565111 (Double Blind: Placebo)	zzfddutkhv(yzxnpmfqpu) = babnsvjezb ilxgrshitx (wvmoznlxrf, 0.73) View more	-	05 Feb 2020
				JNJ-64565111 (Double Blind: JNJ-64565111 5.0 mg)	zzfddutkhv(yzxnpmfqpu) = mdxagqvpvi ilxgrshitx (wvmoznlxrf, 0.76) View more
NCT03586830 (CTgov)	Phase 2	Type 2 diabetes mellitus in obese	196	Placebo	djfpubljzd(jucgiqyxnb) = bidykolwgd oulxrhcrdd (drhbobnnxx, 0.50) View more	-	07 Jan 2020
IAF-Bologna trial (EAN2019)	Not Applicable	Î±-synucleinopathy	422	GLP-1 peptide	eztfkumsyp(lddcgbvein) = lauqenhvib xjavgrbtce (howrpegwjj )	Positive	27 Jun 2019
				Placebo	eztfkumsyp(lddcgbvein) = udjotgabdg xjavgrbtce (howrpegwjj )

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