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 Corp.

100 Clinical Results associated with Efinopegdutide

100 Translational Medicine associated with Efinopegdutide

100 Patents (Medical) associated with Efinopegdutide

230

Literatures (Medical) associated with Efinopegdutide

01 Jan 2025·PHARMACOLOGICAL REVIEWS

Emerging pharmacotherapies for obesity: A systematic review

Article

Author: Al Rifai, Jana ; Valenzuela-Vallejo, Laura ; Rhayem, Caline ; Kokkorakis, Michail ; Mantzoros, Christos S ; Mantzoros, Christos S. ; Chakhtoura, Marlene ; Ghezzawi, Malak

The history of anti-obesity pharmacotherapies is marked by disappointments, often entangled with societal pressure promoting weight loss and the conviction that excess body weight signifies a lack of willpower. However, categories of emerging pharmacotherapies generate hope to reduce obesity rates. This systematic review of phase 2 and phase 3 trials in adults with overweight/obesity investigates the effect of novel weight loss pharmacotherapies, compared to placebo/control or Food and Drug Administration-approved weight loss medication, through searching Medline, Embase, and ClinicalTrials.gov (2012-2024). We identified 53 phase 3 and phase 2 trials, with 36 emerging anti-obesity drugs or combinations thereof and four withdrawn or terminated trials. Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide, survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate. Completed phase 2 trials on incretin-based therapies showed a mean percent weight loss of 7.4-24.2%. Almost half of the drugs undergoing phase 2 trials were incretin analogs. The obesity drug pipeline is expanding rapidly, with the most promising results reported with incretin analogs. Data on mortality and obesity-related complications, such as cardio-renal-metabolic events, are needed. Moreover, long-term follow-up data on the safety and efficacy of weight maintenance with novel obesity pharmacotherapies, along with studies focused on under-represented populations, cost-effectiveness assessments, and drug availability, are needed to bridge the care gap for patients with obesity. Significance Statement Obesity is the epidemic of the 21st century. Except for the newer injectable medications, drugs with suboptimal efficacy have been available in the clinician's armamentarium. However, emerging alternatives of novel agents and combinations populate the obesity therapeutic pipeline. This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives.

01 Jan 2025·JOURNAL OF HEPATOLOGY

Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study

Article

Author: Browne, Sarah K ; Harrison, Stephen A ; Gutierrez, Julio A ; Roberts, M Scot ; Suschak, John J ; Harris, M Scott ; Yang, Jay ; Tomah, Shaheen

BACKGROUND & AIMS:

This was a randomized, double-blind, placebo-controlled study to assess the effects of pemvidutide, a glucagon-like peptide-1 (GLP-1)/glucagon dual receptor agonist, on liver fat content (LFC) in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD).

METHODS:

Patients with a BMI ≥28.0 kg/m² and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks. Participants were stratified according to a diagnosis of type 2 diabetes mellitus. The primary efficacy endpoint was relative reduction (%) from baseline in LFC after 12 weeks of treatment.

RESULTS:

Ninety-four patients were randomized and dosed. Median baseline BMI and LFC across the study population were 36.2 kg/m² and 20.6%; 29% of patients had type 2 diabetes mellitus. At week 12, relative reductions in LFC from baseline were 46.6% (95% CI -63.7 to -29.6), 68.5% (95% CI -84.4 to -52.5), and 57.1% (95% CI -76.1 to -38.1) for the pemvidutide 1.2 mg, 1.8 mg, and 2.4 mg groups, respectively, vs. 4.4% (95% CI -20.2 to 11.3) for the placebo group (p <0.001 vs. placebo, all treatment groups), with 94.4% and 72.2% of patients achieving 30% and 50% reductions in LFC and 55.6% achieving normalization (≤5% LFC) at the 1.8 mg dose. Maximal responses for weight loss (-4.3%; p <0.001), alanine aminotransferase (-13.8 IU/L; p = 0.029), and corrected cT1 (-75.9 ms; p = 0.002) were all observed at the 1.8 mg dose. Pemvidutide was well-tolerated at all doses with no severe or serious adverse events.

CONCLUSIONS:

In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo.

IMPACT AND IMPLICATIONS:

Metabolic dysfunction-associated steatotic liver disease, and its progressive form steatohepatitis, are strongly associated with overweight/obesity and it is believed that the excess liver fat associated with obesity is an important driver of these diseases. Glucagon-like peptide-1 receptor (GLP-1R) agonists elicit weight loss through centrally and peripherally mediated effects on appetite. Unlike GLP-1R agonists, glucagon receptor agonists act directly on the liver to stimulate fatty acid oxidation and inhibit lipogenesis, potentially providing a more potent mechanism for liver fat content reduction than weight loss alone. This study demonstrated the ability of once-weekly treatment with pemvidutide, a dual GLP-1R/glucagon receptor agonist, to significantly reduce liver fat content, hepatic inflammatory activity, and body weight, suggesting that pemvidutide may be an effective treatment for both metabolic dysfunction-associated steatohepatitis and obesity.

CLINICAL TRIAL NUMBER:

NCT05006885.

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.

News (Medical) associated with Efinopegdutide

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

03 Feb 2025

·www.businesswire.com

D&D Pharmatech Announces Completion of Patient Enrollment for a 48-Week Phase 2 Trial Evaluating the Effectiveness of DD01, a Long-Acting, Dual GLP-1/Glucagon Receptor Agonist, in the Treatment of MASH

GYEONGGI-DO, South Korea & GAITHERSBURG, Md.--( BUSINESS WIRE )--D&D Pharmatech, Inc. (D&D) (KOSDAQ: 347850), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, today, announced that patient enrollment has been completed for DD01-DN-2, an ongoing Phase 2 trial designed to evaluate the efficacy and safety of DD01 in overweight/obese subjects with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH). DD01 is a liver-targeted, long-acting, dual GLP-1/glucagon receptor agonist previously shown to rapidly resolve hepatic steatosis, improve glycemic control, and reduce body weight in subjects with fatty liver disease. DD01-DN-2 is a randomized, double-blind, placebo-controlled 48-week Phase 2 trial designed to evaluate the efficacy and safety of 40 mg DD01 administered once weekly in obese/overweight subjects with biopsy-confirmed MASH. Study endpoints include an assessment of MRI-PDFF at 12 weeks with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures, including assessment of MASH resolution and fibrosis improvement at 48 weeks, change in HbA1c, and body weight. Unlike other investigational treatments for MASH, DD01 treatment does not require lengthy titration to reach the therapeutic levels commonly associated with these treatments. The top-line 12-week efficacy and safety results will be announced in late Q2 2025. In a previously completed proof-of-concept study, DD01 was well tolerated in overweight/obese patients with Type 2 diabetes (T2D) and metabolic dysfunction-associated steatotic liver disease (MASLD). Following only 4 weeks of treatment, the 40 mg and 80 mg doses resulted in a mean relative reduction of >50% liver fat content by MRI-PDFF along with decreased HbA1c, reduced liver AST/ALT and serum lipids, as well as evidence of modest weight loss. The US FDA has granted Fast Track designation to DD01 for the treatment of adults with MASH. “We are pleased to report that we have completed enrollment in our Phase 2 trial investigating DD01 in MASH patients,” said Seulki Lee, Ph.D., President and Chief Executive Officer of D&D Pharmatech. “Based on clinical and preclinical studies completed to date, we expect this study to confirm best-in-class potential for DD01 in MASH with long-term treatment accompanied by three key beneficial effects - rapid and robust reductions in liver fat, glucose control, and weight loss leading to clinically significant rates of MASH resolution and fibrosis improvement without the need for the lengthy titration phase.” More information about the current study is available at www.clinicaltrials.gov under the identifier NCT06410924. About DD01 DD01 is a proprietary, once-weekly dual agonist of GLP-1 (glucagon-like peptide-1) and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and MASLD. A key differentiator for DD01 lies in its dual pathway mechanism of action. Unlike single and dual agonists, which act only through the incretin pathway, DD01 is also a glucagon receptor agonist that provides targeted and rapid reductions in liver fat. From the Phase 1 study, doses that result in liver fat reductions of up to 50% are well tolerated, and meaningful effects on the liver are accompanied by improvements in glucose utilization and weight loss. About D&D Pharmatech D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing revolutionary medicines for patients with metabolic, fibrotic, and neurodegenerative diseases. D&D’s R&D activities leverage expertise in developing long-acting and orally active peptide drugs with a strong pipeline of innovative incretin-based therapies in development for the treatment of liver disease, obesity, and neurodegenerative diseases. The clinical-stage pipeline includes DD01, a GLP-1/glucagon dual receptor agonist being developed for MASH. NLY01, a long-acting GLP-1 agonist, recently completed a 36-week Phase 2 trial in >250 Parkinson’s disease patients, revealing statistically significant beneficial effects in young (<60) patients newly diagnosed with PD. Collaborative efforts to extend these findings to the treatment of other chronic and progressive neurodegenerative diseases, including multiple sclerosis, are an important priority. In partnership with Metsera, the company develops various orally active incretin-based peptide drugs for obesity. Offering a new mechanism for treating fibrotic disease, TLY012 directly targets activated myofibroblasts, the source of fibrosis in cirrhosis, scleroderma, and pancreatitis. TLY012 treatment reverses established fibrosis in models of fibrotic disease, including cirrhotic liver, scleroderma, and chronic pancreatitis. FDA granted orphan drug status for TLY012 in the treatment of fibrosis, and IND-enabling studies were recently completed.

Phase 2Fast TrackOrphan DrugClinical ResultPhase 1

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

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Indication	Highest Phase	Country/Location	Organization	Date
Liver Cirrhosis	Phase 2	US	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	JP	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	AU	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	CA	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	CO	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	FR	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	IL	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	PR	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	ES	Merck Sharp & Dohme Corp.	12 Jul 2024
Liver Cirrhosis	Phase 2	TH	Merck Sharp & Dohme Corp.	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)	jvudtqcvcb(vwwyikkppz) = roqdbgfbhn vkmynzsedn (ovcoiehqee, pzkehuqhap - rckrggudzm) View more	-	15 Nov 2023
				Semaglutide 1.34 mg/mL (Semaglutide)	jvudtqcvcb(vwwyikkppz) = hifpqdatvl vkmynzsedn (ovcoiehqee, wbkpmgmbgy - nziubtbqmp) View more
AASLD2023	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	145	Efinopegdutide 10 mg QW	lrembvodgp(jljefppwwy) = wvudxzrqpl pqdzrzyodd (wylnrfbhot ) View more	-	10 Nov 2023
				Semaglutide 1.0 mg QW	lrembvodgp(jljefppwwy) = sifplslwni pqdzrzyodd (wylnrfbhot ) View more
EUCTR2020-005136-30-ES \| NCT04944992 (EASD2023)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic dysfunction-associated steatotic liver disease	145	Efinopegdutide 10 mg	wopsehuurz(jvoymkkbzk) = yzucnzboiv pwdtubzfoq (hwcibdgsyb, 57.2 - 76.3) View more	Positive	04 Oct 2023
				Semaglutide 1 mg	wopsehuurz(jvoymkkbzk) = nhozjrgkba pwdtubzfoq (hwcibdgsyb, 36.0 - 55.1) View more
EUCTR2020-005136-30-ES \| NCT04944992 (Pubmed)	Phase 2	Metabolic dysfunction-associated steatotic liver disease	145	Efinopegdutide 10 mg	jfunryhmhy(kfugcsrcdm) = chhaxgcwzq rzkbeexctg (dktpemumjm, 66.8 - 78.7) View more	Positive	01 Oct 2023
				Semaglutide 1 mg	jfunryhmhy(kfugcsrcdm) = qdfcmrerwc rzkbeexctg (dktpemumjm, 36.5 - 48.1) View more
NCT03486392 (CTgov)	Phase 2	Obesity	474	placebo+JNJ-64565111 (Double Blind: Placebo)	quhpbyivcq(plzltxkzjo) = kwjjmgfppc uauuclrwbp (rcuyamrbgh, wnkfoxajvc - pljmvfhyzd) View more	-	05 Feb 2020
				JNJ-64565111 (Double Blind: JNJ-64565111 5.0 mg)	quhpbyivcq(plzltxkzjo) = eyzqcwcrjw uauuclrwbp (rcuyamrbgh, rnexgyhvfs - drnzxwijnx) View more
NCT03586830 (CTgov)	Phase 2	Type 2 diabetes mellitus in obese	196	Placebo	ewkvgfjsle(zfwpljbcky) = sqimiwcxuu wucxdblthl (xvzdfyumdh, qglxtchgfs - ygvomlzjlf) View more	-	07 Jan 2020
IAF-Bologna trial (EAN2019)	Not Applicable	Î±-synucleinopathy	422	GLP-1 peptide	dssygzbgii(qijqdshvhk) = wclmmgnqlr nffgmpcbcf (jpjpvcaasb )	Positive	27 Jun 2019
				Placebo	dssygzbgii(qijqdshvhk) = wnllkjqdmm nffgmpcbcf (jpjpvcaasb )

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