{"id":63165,"date":"2026-05-27T10:03:10","date_gmt":"2026-05-27T08:03:10","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/dd-pharmatech-announces-positive-48-week-histology-results-for-zabopegdutide-dd01-demonstrating-statistically-significant-fibrosis-improvement-and-mash-resolution\/"},"modified":"2026-05-27T10:03:10","modified_gmt":"2026-05-27T08:03:10","slug":"dd-pharmatech-announces-positive-48-week-histology-results-for-zabopegdutide-dd01-demonstrating-statistically-significant-fibrosis-improvement-and-mash-resolution","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/dd-pharmatech-announces-positive-48-week-histology-results-for-zabopegdutide-dd01-demonstrating-statistically-significant-fibrosis-improvement-and-mash-resolution\/","title":{"rendered":"D&amp;D Pharmatech Announces Positive 48-Week Histology Results for Zabopegdutide (DD01), Demonstrating Statistically Significant Fibrosis Improvement and MASH Resolution"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nAll key histological endpoints achieved with statistical significance<\/li>\n<li>\n50.0% of patients achieved \u22651-stage fibrosis improvement with no worsening of MASH, compared to 15.8% for placebo<\/li>\n<li>\n62.5% achieved MASH resolution with no worsening of fibrosis, versus 5.3% for placebo<\/li>\n<li>\n37.5% achieved both fibrosis improvement and MASH resolution, compared to 5.3% for placebo<\/li>\n<li>\nResults support potential best-in-class profile for once-weekly GLP-1\/glucagon dual agonist in MASH<\/li>\n<\/ul>\n<p>GYEONGGI-DO, South Korea &amp; GAITHERSBURG, Md.&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ddpharmatech.com%2Fen%2F&amp;esheet=54542530&amp;newsitemid=20260526295057&amp;lan=en-US&amp;anchor=D%26amp%3BD+Pharmatech%2C+Inc.+%28D%26amp%3BD%29&amp;index=1&amp;md5=0d6e4e7f6d5d8d119579c2670bfb268c\" rel=\"nofollow\" shape=\"rect\">D&amp;D Pharmatech, Inc. (D&amp;D)<\/a> (KOSDAQ: 347850), a clinical-stage biotechnology company developing breakthrough treatments for liver and metabolic diseases, today announced positive top-line 48-week histology results from its Phase 2 trial (DD01-DN-02) evaluating zabopegdutide (DD01) in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH).<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20260526295057\/en\/2815940\/4\/DandD_logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260526295057\/en\/2815940\/22\/DandD_logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20260526295057\/en\/2815940\/4\/DandD_logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260526295057\/en\/2815940\/21\/DandD_logo.jpg\"><\/a><\/p>\n<p>\nFollowing the rapid and robust liver fat reduction observed at the Week 12 primary analysis (<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.businesswire.com%2Fnews%2Fhome%2F20250616477730%2Fen%2FDD-Pharmatech-Announces-Positive-Phase-2-Results-for-DD01-in-MASH-with-Robust-Reductions-in-Liver-Fat-Accompanied-by-Improvements-in-Liver-and-Metabolic-Health&amp;esheet=54542530&amp;newsitemid=20260526295057&amp;lan=en-US&amp;anchor=businesswire&amp;index=2&amp;md5=82faf8665f2e66294b8d15a7478ab5eb\" rel=\"nofollow\" shape=\"rect\"><i>businesswire<\/i><\/a>), the final 48-week biopsy data demonstrated that zabopegdutide produced significant histological improvements in patients with biopsy-confirmed MASH and fibrosis stage F1-F3. The study met all three key histological endpoints, demonstrating the potential of zabopegdutide to both resolve steatohepatitis and reverse liver fibrosis.<\/p>\n<p>\n<b>Key Histological Findings at Week 48<\/b><\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl bwwidth100\">\n<tr>\n<td class=\"bwtopsingle bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth55\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b>Endpoint<\/b><\/p>\n<\/td>\n<td class=\"bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>Placebo<\/b><\/p>\n<p class=\"bwalignc bwcellpmargin\">\n<b>(n=19)<\/b><\/p>\n<\/td>\n<td class=\"bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>DD01 40 mg<\/b><\/p>\n<p class=\"bwalignc bwcellpmargin\">\n<b>(n=16)<\/b><\/p>\n<\/td>\n<td class=\"bwtopsingle bwsinglebottom bwrightsingle bwpadl0 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n<b>p-value<\/b><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth55\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nFibrosis Improvement (\u22651 stage) with No Worsening of MASH<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwpadb3 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n15.8%<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwpadb3 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n50.0%<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n&lt;0.05<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth55\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nMASH Resolution with No Worsening of Fibrosis<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwpadb3 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n5.3%<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwpadb3 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n62.5%<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n&lt;0.001<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwsinglebottom bwleftsingle bwrightsingle bwpadl0 bwwidth55\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nBoth Fibrosis Improvement (\u22651 stage) and MASH Resolution<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwpadb3 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n5.3%<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwpadr0 bwpadb3 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignc\">\n37.5%<\/p>\n<\/td>\n<td class=\"bwsinglebottom bwrightsingle bwpadl0 bwwidth15 bwalignc bwvertalignt\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwalignc bwcellpmargin\">\n&lt;0.05<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n<i>Note: Percentages represent responder rates in the Per Protocol population. P-values were calculated using the prespecified Cochran-Mantel-Haenszel (CMH) test as outlined in the study\u2019s Statistical Analysis Plan.<\/i><\/p>\n<p>\nThe DD01-DN-02 study was a randomized, double-blind, placebo-controlled Phase 2 trial conducted at 12 centers in the United States. The study enrolled 67 overweight\/obese subjects with MASH and significant liver fat who received a 2-week titration at 20 mg followed by a 40 mg once-weekly maintenance dose of zabopegdutide or placebo. The Week 48 Per Protocol population included 35 subjects with biopsy-confirmed MASH and fibrosis (F1-F3) who completed paired baseline and the Week 48 liver biopsies and demonstrated high adherence to the treatment regimen and study protocol.<\/p>\n<p>\nThe placebo-adjusted effect size for fibrosis improvement with no worsening of MASH was 34.2% (p=0.0323), while the placebo-adjusted effect size for MASH resolution with no worsening of fibrosis was 57.2% (p=0.0003). Notably, the placebo-adjusted effect size for achieving both fibrosis improvement and MASH resolution was 32.2% (p=0.0192). These histological improvements were accompanied by significant reductions in liver fat measured by MRI-PDFF, liver stiffness measured by MRE, and multiple fibrosis biomarkers.<\/p>\n<p>\n&#8220;These 48-week results represent a major milestone for zabopegdutide and for patients living with MASH,&#8221; said Seulki Lee, Ph.D., President and CEO of D&amp;D Pharmatech. &#8220;While we were encouraged by the rapid fat reduction and early improvements in liver stiffness at Week 12, seeing these effects translate into statistically significant fibrosis improvement at Week 48 is particularly compelling. Achieving significance across MASH resolution, fibrosis improvement, and the composite endpoint further supports the differentiated potential of zabopegdutide as a next-generation therapy for MASH.&#8221;<\/p>\n<p>\n<b>A Differentiated Mechanism for Disease Reversal<\/b><\/p>\n<p>\nZabopegdutide is a long-acting, once-weekly dual agonist targeting both GLP-1 and glucagon receptors. While GLP-1 receptor agonism provides powerful metabolic benefits and weight loss, the addition of glucagon receptor agonism directly enhances hepatic lipid metabolism and contributes to anti-fibrotic activity within the liver.<\/p>\n<p>\nThe Week 48 data further support the differentiated profile of dual GLP-1\/glucagon agonism, demonstrating that rapid and profound reductions in liver fat and liver stiffness observed early in treatment are durable and can translate into meaningful histological improvements following long-term therapy. In addition to biopsy endpoints, zabopegdutide treatment demonstrated continued improvements in non-invasive markers of liver health, body weight, and glycemic control, including HbA1c.<\/p>\n<p>\n\u201cFor clinicians managing progressive MASH, the absolute priority is to stop or reverse fibrosis before it leads to irreversible cirrhosis or hepatic decompensation. The fact that 50% of patients treated with zabopegdutide experience a \u2265 1-stage improvement in fibrosis in less than a year is highly encouraging for the hepatology community. Coupled with a well-tolerated safety profile and low discontinuation rates, zabopegdutide is positioning itself as an incredibly robust and viable next-generation therapeutic option for individuals living with advanced metabolic liver disease,\u201d commented Mazen Noureddin, MD, MHSc, Professor of Medicine at Houston Methodist Hospital; Co-Chairman of the Board, Summit &amp; Pinnacle Clinical Research; Director, Houston Research Institutes.<\/p>\n<p>\nThe results from this study are presented at the EASL Congress 2026 in Barcelona, Spain, and are expected to be featured at additional upcoming scientific meetings.<\/p>\n<p>\n<b>Safety and Tolerability<\/b><\/p>\n<p>\nZabopegdutide remained well-tolerated from the initial 2-week dose-escalation phase through 48 weeks of treatment. The most common adverse events were gastrointestinal, which were generally mild-to-moderate and transient. Discontinuation rates were consistent with those observed for other incretin-based therapies in this patient population.<\/p>\n<p>\n<b>About Zabopegdutide (DD01)<\/b><\/p>\n<p>\nZabopegdutide is a proprietary, long-acting GLP-1\/glucagon receptor dual agonist. By targeting both receptors, zabopegdutide aims to reduce liver fat, resolve inflammation, and reverse fibrosis more effectively than GLP-1 monotherapies.<\/p>\n<p>\nIn Phase 1 studies, zabopegdutide reduced liver fat by up to 50% in only 4 weeks in obese subjects with MASLD, accompanied by improvements in glucose tolerance and modest weight loss.<\/p>\n<p>\nIn earlier Phase 2 analysis, more than 70% of subjects treated with zabopegdutide achieved greater than 50% reduction in liver fat after 12 weeks of treatment, while approximately 50% achieved normalization of liver fat (&lt;5%). These effects were accompanied by significant reductions in liver stiffness (MRE) and fibrosis biomarkers, including pro-C3 and ELF.<\/p>\n<p>\nThe pharmacokinetic profile of zabopegdutide, characterized by slow absorption (Tmax, ~6 days) and prolonged half-life, supports gradual systemic exposure and contributes to its favorable tolerability at clinically active doses. The GLP-1:glucagon potency ratio (11:1) is designed to balance metabolic efficacy, weight loss, and glycemic control, while glucagon receptor activity is believed to drive the rapid reduction in hepatic steatosis.<\/p>\n<p>\nZabopegdutide\u2019s differentiated profile, combining rapid liver fat reduction, significant histological improvement, potential weight-independent liver benefits, and convenient once-weekly dosing, positions it as a next-generation therapy for MASH.<\/p>\n<p>\n<b>About D&amp;D Pharmatech<\/b><\/p>\n<p>\nD&amp;D Pharmatech is a clinical-stage biopharmaceutical company focused on developing revolutionary medicines for patients with metabolic, fibrotic, and neurodegenerative diseases.<\/p>\n<p>\nIts liver pipeline includes zabopegdutide and TLY012 for MASH and cirrhosis, with TLY012 demonstrating reversal of established fibrosis in multiple preclinical models, including liver cirrhosis, chronic pancreatitis, and systemic sclerosis. In neuroscience, pegsebrenatide (NLY01) and NLY02 target neuroinflammation and glial activation to slow neurodegeneration; pegsebrenatide has demonstrated clinical benefit in a Phase 2 Parkinson\u2019s disease study, particularly in patients younger than 60, and is currently being evaluated in progressive multiple sclerosis.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nNeuraly, Inc.<br \/>\n<br \/>Ben Gibson<br \/>\n<br \/>240-937-5876<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;o&#x3a;&#98;&#x67;&#105;&#x62;&#115;o&#x6e;&#64;&#x6e;e&#x75;&#114;&#x61;&#108;&#x79;&#109;&#x65;&#100;&#46;&#x63;o&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#x62;&#x67;&#x69;&#x62;&#x73;&#x6f;&#x6e;&#x40;&#x6e;&#x65;&#x75;&#x72;&#x61;&#x6c;&#x79;&#x6d;&#x65;&#x64;&#x2e;&#x63;&#x6f;&#x6d;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>All key histological endpoints achieved with statistical significance 50.0% of patients achieved \u22651-stage fibrosis improvement with no worsening of MASH, compared to 15.8% for placebo 62.5% achieved MASH resolution with no worsening of fibrosis, versus 5.3% for placebo 37.5% achieved both fibrosis improvement and MASH resolution, compared to 5.3% for placebo Results support potential best-in-class &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/dd-pharmatech-announces-positive-48-week-histology-results-for-zabopegdutide-dd01-demonstrating-statistically-significant-fibrosis-improvement-and-mash-resolution\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-63165","format-standard","category-industry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>D&amp;D Pharmatech Announces Positive 48-Week Histology Results for Zabopegdutide (DD01), Demonstrating Statistically Significant Fibrosis Improvement and MASH Resolution - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/dd-pharmatech-announces-positive-48-week-histology-results-for-zabopegdutide-dd01-demonstrating-statistically-significant-fibrosis-improvement-and-mash-resolution\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"D&amp;D Pharmatech Announces Positive 48-Week Histology Results for Zabopegdutide (DD01), Demonstrating Statistically Significant Fibrosis Improvement and MASH Resolution - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"All key histological endpoints achieved with statistical significance 50.0% of patients achieved \u22651-stage fibrosis improvement with no worsening of MASH, compared to 15.8% for placebo 62.5% achieved MASH resolution with no worsening of fibrosis, versus 5.3% for placebo 37.5% achieved both fibrosis improvement and MASH resolution, compared to 5.3% for placebo Results support potential best-in-class ... 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