zabopegdutide (DD01) / D&D Pharmatech, Shenzhen Salubris - LARVOL DELTA

D&D Pharmatech Announces The Lancet Gastroenterology & Hepatology Publication of Phase 2 Data Demonstrating Rapid, Weight-Independent Activity of Zabopegdutide (DD01) in MASLD/MASH (Businesswire) - "The randomized, double-blind, placebo-controlled Phase 2 DD01-DN-02 trial (NCT06410924) enrolled 67 overweight or obese patients with MASLD/MASH who received a 2-week titration at 20 mg followed by a 40 mg once-weekly maintenance dose....Following a 1:1 randomization to 40 mg DD01 or placebo, the 12-week results showed that 75.8% of subjects treated with DD01 achieved at least a 30% reduction in liver fat, and moreover, 72.7% of subjects achieved greater than 50% reduction in liver fat, and 48.5% of treated subjects achieved normalization of liver fat (<5%)....Among patients who achieved less than 5% of body weight loss by Week 12, zabopegdutide still produced significant reductions in liver fat (-37.4% by MRI-PDFF) and liver stiffness (-19.2% by MRE)."

P2 data • Metabolic Dysfunction-Associated Steatotic Liver Disease

The glucagon and GLP-1 receptor dual agonist DD01 for metabolic dysfunction-associated steatotic liver disease and steatohepatitis (DD01-DN-02): 12-week results from a randomised, double-blind, multicentre, placebo-controlled, phase 2 trial. (PubMed, Lancet Gastroenterol Hepatol) - P2 | "In this prespecified 12-week primary analysis, DD01 produced rapid reductions in liver fat compared with placebo, supporting further evaluation in long-term studies."

Journal • P2 data • Addiction (Opioid and Alcohol) • Gastroenterology • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Pain

Neuraly, the U.S. subsidiary of D&D Pharmatech, has been invited to present at the Shark Tank session of the 'SOLAR Conference 2026,' an academic event focused on MASH (Metabolic dysfunction-associated steatohepatitis) (The Asia Business Daily) - "Neuraly will directly explain the Phase 2 clinical trial results of Zabopegdutide in front of executives from major pharmaceutical companies....Adam Bell...will share the recently released, competitive Phase 2 tissue biopsy results for Zabopegdutide and discuss their clinical significance and future development strategies with the panel."

P2 data • Metabolic Dysfunction-Associated Steatohepatitis

Weight loss–independent Glucagon effect led to rapid, clinically significant reductions in MASH severity, including steatosis and liver stiffness, during a 48-week randomized controlled trial of dual agonist DD01 (EASL 2026) - P2 | "DD01 demonstrated significant reductions in liver fat and improvements in markers of MASH severity at 12 weeks, including in patients with minimal weight loss, supporting potential weight-independent hepatic effects. Further data, including histological outcomes at 48 weeks, will help clarify the durability and clinical relevance of these findings."

Clinical • Late-breaking abstract • Fibrosis • Immunology • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech hits phase 2 MASH endpoints, boosts tech transfer push (Chosun Biz) - "As a result, first, on the 'liver fibrosis improvement' endpoint that the U.S. Food and Drug Administration (FDA) regards as critical in approving MASH therapies, half (50%) of patients treated with DD01 showed improvement. The improvement rate in the placebo group was 15.8%. Put simply, about one in two patients on DD01 saw an improvement in liver scarring (fibrosis). Another key endpoint, 'MASH resolution,' was also clear. In 62.5% of the DD01 group, liver inflammation and fat accumulation improved, resulting in MASH resolution. By contrast, only 5.3% in the placebo group showed the same effect."

P2 data • Metabolic Dysfunction-Associated Steatohepatitis

DND Pharmatech Completes KRW 226.5 Billion Convertible Bond Payment, Reflecting Expectations for DD01 (The Asia Business Daily) - "The market views this fundraising as reflecting expectations for the results of the Phase 2 clinical trial of DD01, the company’s lead pipeline for MASH (Metabolic Dysfunction-Associated Steatohepatitis) treatment, as well as the potential for future technology transfer...The company plans to use the secured funds to expand clinical trials and R&D for its follow-up pipeline, including the fibrosis treatment candidate TLY012. TLY012 aims to enter clinical trials as early as the beginning of next year."

Financing • New trial • Fibrosis • Metabolic Dysfunction-Associated Steatohepatitis

DD01-DN-02: A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: Neuraly, Inc. | Active, not recruiting ➔ Completed

Trial completion • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

D&D Pharmatech to Unveil Phase 2 DD01 Clinical Trial Results for the First Time at EASL Congress (The Asia Business Daily) - "The company expects to receive the top-line data, including liver biopsy results, after the middle of next month, following the database lock, and plans to release the final, complete analysis in time for the opening of the congress on the 27th of next month."

Late-breaking abstract • P2 data • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech's DD01 clinical trial under FDA review [Google translation] (HIT News) - "According to the company, with this LOI acceptance, the FDA has formalized its position to consider using MRE measurements as a quantitative biomarker in clinical trials targeting patients with metabolic-associated steatohepatitis (MASH) in stages F2-F3. If MRE is ultimately recognized as a RLSE, discussions for accelerated approval based solely on MRE data could be possible, without the need for a tissue biopsy....plans to announce the top-line results of the Phase 2 clinical trial, including the results of tissue biopsy and MRE, in the first half of 2026."

FDA event • P2 data • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmatech, a company specializing in the development of new GLP-1 (glucagon-like peptide-1) drugs, announced on January 20 that it has decided to register patents for its MASH (metabolic dysfunction-associated steatohepatitis) treatment candidate DD01 in China and India. (The Asia Business Daily) - "This patent registration decision is significant as it marks the full-scale expansion of DD01's intellectual property rights into the Asian region, one of the world's largest markets, following previous registrations in key countries such as the United States, Australia, and Russia."

Patent • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech completes 48-week dosing of DD01 in US MASH trial, will report topline in May (Chosun Biz)

P2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech's DD01 wins KDDF outstanding project designation (Chosun Biz) - "KDDF awards D&D Pharmatech 4.55 billion to advance DD01 phase 2 MASH trial; D&D Pharmatech's DD01 task (phase 2 stage) was selected as an outstanding task in recognition of its excellent development progress and potential, and an awards ceremony was held that day."

Financing • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

…D&D Pharmatech presented interim results of Phase 2 clinical trials for DD01, a dual-action GLP-1/glucagon MASH treatment, at the American Association for the Study of the Liver (AASLD) Annual Meeting… [Google translation] (PRESS9) - "...confirming reductions in liver fat and improvements in metabolic indicators at 12- and 24-week dosing points. DD01 is currently being administered for 48 weeks in the US to MASLD/MASH patients, and the company plans to secure regulatory requirements, including tissue biopsy results, by the first half of 2026."

P2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmatech Registers Patent for MASH Drug Candidate 'DD01' in Israel [Google translation] (HIT News)

Patent • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech…announced on the 27th that the primary endpoint and 12-24 week dosing results of the US Phase 2 clinical trial of ’DD01’, a candidate for the treatment of MASH (metabolic steatohepatitis), were selected for oral presentation as a ’Late-Breaking Abstract’ at the American Association for the Study of Liver Diseases (AASLD 2025). [Google translation] (HIT News)

Late-breaking abstract • P2 data • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmatech's MASH (metabolic-related steatohepatitis) treatment "DD01" received positive results in the 24th week of the U.S. phase 2 clinical trial. (Maeil Business Newpaper) - "In this 24th week analysis, fibrosis-related biomarkers (ELF Score, PRO-C3) continued to improve compared to the placebo group. In particular, statistically significant improvement was confirmed in the core patient group with F2 to F3 stage fibrosis...The weight loss effect was also evident. At week 12, a weight loss of more than 5% was observed in 42.4% of the total administration group, and at week 24, the proportion increased to 51.5%. The average weight loss rate was also 6.4%...This is a meaningful achievement considering that the reduction effect of GLP-1-based drugs in MASH patients is 30-40% lower than in general obese patients....The final results of major evaluation indicators are expected to be announced in the first half of next year."

P2 data • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech pursues direct perpetual CB issuance without underwriter (Chosun Biz) - "D&D Pharmatech seeks private investors for 80 billion won perpetual CBs after underwriting talks fail...D&D Pharmatech chose this perpetual CB issuance to raise funds for new drug development. The company is currently conducting a phase 2 clinical trial in the U.S. for DD01, a metabolic dysfunction-associated steatohepatitis (MASH) treatment that is also known as an obesity drug, and the need for funding has grown ahead of plans to advance clinical development of the anti-fibrosis treatment TLY012."

Financing • Fibrosis • Metabolic Dysfunction-Associated Steatohepatitis

[HIT Algong] If you are curious about the clinical results of DND Pharmatech DD01, pay attention to IR on the 18th [Google translation] (HIT News) - "D&D Pharmatech holds corporate briefing (IR): July 18 in Seoul for institutional investors, announces interim results of phase 2 clinical trial of MASH treatment DD01 and development plan for obesity treatment, hosted by NH Investment & Securities."

P2 data • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

DND Pharmatech Completes 24th Week Dosing of MASH Treatment 'DD01' Phase 2 Clinical Trial [Google translation] (Medical Today) - "D&D Pharmatech...announced that it has successfully completed the 24th week of dosing for all patients in the phase 2 clinical trial of 'DD01', a MASH (metabolic steatohepatitis) treatment that it is developing. D&D Pharmatech is currently conducting an analysis of key blood biomarkers, including weight changes, following the completion of the 24th week of dosing, and plans to disclose the results at a later date...Currently, a phase 2 clinical trial is underway in the US targeting MASLD/MASH patients....Accordingly, the final key evaluation results, including the results of the liver tissue biopsy and reduction of fatty liver required for the FDA's MASH approval requirements, are expected to be announced in the first half of 2026."

P2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmatech Announces Positive Phase 2 Results for DD01 in MASH with Robust Reductions in Liver Fat Accompanied by Improvements in Liver and Metabolic Health (Businesswire) - P2 | N=67 | DD01-DN-02 (NCT06410924) | Sponsor: Neuraly, Inc. | "Results of a planned 12-week assessment of safety and efficacy revealed DD01 was well tolerated, and the study’s primary endpoint was met. Following a 1:1 randomization of 40mg DD01 and placebo, 75.8% of subjects treated with DD01 achieved at least a 30% reduction in liver fat, 72.7% of subjects achieved greater than 50% reduction in liver fat, and 57.6% of subjects achieved greater than 70% liver fat reduction (in each case, with p < 0.0001). DD01 achieved a mean reduction of liver fat content of 62.3% vs 8.3% for placebo at 12 weeks of treatment, and 48.5% of DD01 subjects achieved normalization of liver fat fraction (defined as liver fat fraction of 5% or less by MRI-PDFF)."

P2 data • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmatech Completes Database Lock for Phase 2 Clinical Trial of MASH Treatment in the US [Google translation] (HIT News) - P2 | N=67 | NCT06410924 | Sponsor: Neuraly, Inc. | "D&D Pharmatech announced on the 4th that it has completed the database lock for the analysis of the primary evaluation index in the US phase 2 clinical trial of 'DD01', a treatment for MASH (metabolic steatohepatitis)...This lock is based on data from all patients who completed the treatment by week....The clinical trial will be conducted at approximately 12 institutions in the United States, and will be designed as a randomized, double-blind, placebo-controlled study targeting 67 patients with a body mass index (BMI) of 25 or more and MASLD/MASH....D&D Pharmatech announced that based on the 12-week interim data secured by the end of March, 16 out of 50 subjects, who were not divided into the placebo and treatment groups, showed a 70% or greater reduction in liver fat."

P2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

D&D Pharmtech scores US patent for MASH drug candidate DD01 (Korea Biomedical Review) - "D&D Pharmatech, a Korean developer of GLP-1-based therapeutics, announced Tuesday that it has secured a U.S. patent for DD01, its investigational treatment for metabolic-associated steatohepatitis (MASH)....The U.S. patent is the second international registration for DD01, following the initial filing in Korea in 2019 and recent approval in Australia....The ongoing phase 2 study is designed as a 48-week trial, with dosing continuing after confirmation of the primary endpoint...including biopsy-confirmed resolution of MASH and improvement in liver fibrosis after 48 weeks. Final results are anticipated in the first half of 2026."

P2 data • Patent • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech completes US phase 2 dosing of MASH drug, eyes June data release (Korea Biomedical Review) - "D&D Pharmatech, a GLP-1 drug developer, said Friday it has completed week 12 dosing of all patients in its U.S. phase 2 clinical trial of DD01, a drug for metabolic-associated steatohepatitis (MASH)....The company is analyzing key data, including the primary endpoint, MRI-PDFF, and will release the results by June....The primary endpoint will be assessed using MRI-PDFF at week 12 of the 48-week treatment period to determine the proportion of patients with at least a 30 percent reduction in liver fat, and at week 48, tissue biopsies will be taken to confirm resolution of MASH and improvement in fibrosis, providing key data for FDA approval....Results from the primary endpoint are expected in mid-June, subject to completion of week 12 dosing for all patients."

P2 data • Trial status • Metabolic Dysfunction-Associated Steatohepatitis

D&D Pharmatech, MASH Treatment 'DD01', Australian Patent Registration Decision [Google translation] (BioTimes) - "D&D Pharmatech (347850), a company specializing in the development of GLP-1 series new drugs, announced on the 2nd that it has decided to register an Australian patent for 'DD01', a MASH (metabolic steatohepatitis) treatment drug that the company is developing."

Patent • Metabolic Dysfunction-Associated Steatohepatitis

DD01-DN-02: A Study to Evaluate DD01 in Overweight/Obese Subjects with MASLD/MASH (clinicaltrials.gov) - P2 | N=68 | Active, not recruiting | Sponsor: Neuraly, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity