Survodutide

DA-1726 Phase 1, 48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau Vanoglipel Combined with Resmetirom Demonstrated Synergistic Hepatoprotective and Weight-Loss Effects in Preclinical MASH Model Vanoglipel Combined with Metformin Demonstrated Enhanced Glycemic Control and Body Weight Reduction Versus Monotherapy in a Preclinical T2D Model CAMBRIDGE, Mass., June 8, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the presentation of new late-breaking data highlighting its obesity and metabolic disease portfolio at the American Diabetes Association's (ADA) 2026 Scientific Sessions, held June 5–8 in New Orleans, Louisiana. The presentations included new Phase 1 higher-dose cohort results for DA-1726, a novel dual agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), as well as preclinical data supporting combination treatment potential for vanoglipel (DA-1241), a novel G-protein-coupled receptor 119 (GPR119) agonist, in metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes (T2D) and obesity. The data highlighted favorable safety, tolerability and clinically meaningful reductions in body weight and waist circumference for DA-1726 at the 48 mg dose level, while the vanoglipel presentations demonstrated synergistic metabolic, liver-related effects and weight loss when combined with current standards of care, supporting potential combination strategies across MASH, T2D and obesity. "The late-breaking ADA 2026 data further reinforces the differentiated and complementary potential of our cardiometabolic pipeline," said Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "DA-1726 demonstrated clinically meaningful and progressive weight loss up to 9.1% at the 48 mg dose level without evidence of plateau, along with consistent reductions in waist circumference and BMI in a once-weekly regimen without titration. Importantly, the data also demonstrates a sustained and progressive metabolic effect through Day 54, supporting continued advancement of higher-dose evaluation in our ongoing Phase 1 Part 3 titration studies designed to assess higher-dose exposure and durability of metabolic response, with results expected in the fourth quarter of 2026." "In parallel, preclinical vanoglipel combination data demonstrated synergistic effects across liver and metabolic disease models, including meaningful improvements in hepatic steatosis, liver injury markers, fibrosis-related biomarkers, glycemic control, and body weight. Importantly, when combined with resmetirom, vanoglipel's ability to unlock synergistic benefits highlights its potential as a combination strategy for MASH. In addition, when combined with metformin, vanoglipel improved glycemic control and reduced body weight to a greater extent than either monotherapy, further supporting its potential as a therapeutic combination strategy for additional metabolic benefit in T2D. Taken together, these findings further support DA-1726 as a differentiated obesity therapy and vanoglipel as a versatile metabolic backbone for combination approaches in MASH and type 2 diabetes." Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue: Phase 1 Higher-Dose Cohort Results Presenting Author: Weikai "Chris" Fang, Chief Medical Officer, MetaVia Abstract Control Number: 3102-LB Session: 23-B Obesity—Human The late-breaking poster presentation of DA-1726 reported interim results from a randomized, double-blind, placebo-controlled Phase 1 multiple ascending dose study evaluating once-weekly subcutaneous administration in obese but otherwise healthy adults. In the 48 mg cohort, DA-1726 was generally well tolerated, with predominantly mild-to-moderate and transient gastrointestinal adverse events and no treatment-related discontinuations or serious adverse events. Pharmacokinetic (PK) analysis demonstrated sustained exposure with dose-proportional behavior. DA-1726 produced a 6.1% reduction in body weight at Day 26 and a 9.1% reduction at Day 54 (p<0.05 vs placebo at Day 26), with continued reductions through Week 8 and no evidence of plateau. Waist circumference was reduced by 5.8 cm at Day 22 and 9.8 cm at Day 54 (p<0.05 vs placebo), with accompanying reductions in BMI of 2.3 kg/m² and 3.4 kg/m² at Day 22 and Day 54, respectively. These clinically meaningful, statistically significant body weight reductions at higher doses were consistent with the dose-proportional PK profile and support continued development for obesity. Title: Synergistic Hepatoprotective and Weight-Loss Effects of Vanoglipel and Resmetirom Combination Therapy in a Diet-Induced Obese, Biopsy-Confirmed Mouse Model of MASH Presenting Author: Yuna Chae, Lead Research Scientist, Dong-A ST Research Center Abstract Control Number: 3043-LB Session: 22-C Integrated Physiology—Liver The late-breaking preclinical study evaluating vanoglipel in combination with resmetirom demonstrated synergistic hepatoprotective and weight-loss effects in a biopsy-confirmed diet-induced obese mouse model of MASH. While monotherapies had no significant effect on body weight, combination treatment achieved a 23.6% reduction versus control (p<0.05), with endpoint fat mass and epididymal fat weight reduced by 43.5% and 42.1%, respectively. All treatments decreased ALT, with the largest reduction rate of 83.5% in the combination group. Histopathologic assessment showed significant improvements in hepatic lipid accumulation, inflammation and fibrosis-related biomarkers. The study represents the first demonstration of the therapeutic potential of combined targeting of GPR119 and thyroid hormone receptor beta (THRβ) for MASH. Title: Synergistic Effects of Vanoglipel and Metformin on Glycemic Control and Body Weight Reduction in a Diet-Induced Obese Mouse Model Presenting Author: Tae Hyoung Kim, Lead Research Scientist, Dong-A ST Research Center Abstract Control Number: 2856-LB Session: 12-D Clinical Therapeutics—Other Therapeutic Agents The late-breaking preclinical study evaluating vanoglipel in combination with metformin demonstrated greater metabolic and weight effects than either monotherapy in a diet-induced obese mouse model with mild hyperglycemia. Combination treatment reduced non-fasting glucose by 28.7% (p<0.05) and fasting glucose by 22.7% versus control. While each monotherapy reduced body weight by approximately 4%, the combination achieved a 16.3% reduction versus control (p<0.05). Fat mass increased by 0.4-1.4 g from baseline in the control and monotherapy groups but decreased by 3.6 g in the combination group (-25.6% vs baseline, p<0.05). These effects were accompanied by increases in total GLP-1 and peptide YY (PYY) levels of 6.4-fold and 1.5-fold, respectively, along with reduced food intake, supporting enhanced gut hormone–mediated metabolic activity. A copy of the posters will be available on the Posters section of the MetaVia website after the presentation. About DA-1726 DA-1726 is a novel GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in preclinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in preclinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction. About Vanoglipel (DA-1241) Vanoglipel is a once daily, orally available G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the pancreas stimulates glucose-dependent insulin secretion, and in the gut, it promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver pathology including steatosis, inflammation and fibrosis, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a and 1b trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists such as semaglutide. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). In preclinical studies, vanoglipel demonstrated a positive metabolic effect on glucose and lipid control, and also proved differentiated hepatic benefits reducing hepatic steatosis, hepatic inflammation, and liver fibrosis regardless independent of metabolic improvement. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of preclinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com SOURCE MetaVia Inc. 21% more press release views with Request a Demo

Nearly a quarter of patients on the higher 6 mg dose discontinued treatment due to an adverse event. \n Boehringer Ingelheim spent the weekend pointing to survodutide\'s “targeted” weight loss, but the latest data couldn’t shake off concerns about the obesity drug’s tolerability.The deep dive into survodutide’s performance—presented Sunday at the American Diabetes Association 2026 Scientific Sessions in New Orleans—reaffirmed that survodutide was linked to an average weight decrease of 16.6% on the efficacy estimand, versus 3.2% among patients in the phase 3 Synchronize-1 trial’s placebo cohort. By that metric, the average weight loss on survodutide is in the ballpark of the originally approved highest dose of Novo Nordisk’s Wegovy, although it falls short of Eli Lilly’s Zepbound. New to the table were detailed glimpses into the dual agonist’s ability to cut specific types of weight thought to have the greatest impact on overall metabolic health, while also potentially better preserving lean mass than other comparable therapies. Namely, a sub-study of Synchronize-1 that looked at patients who provided MRI measurements at baseline and the end of the trial showed a relative reduction of up to 34% visceral fat—a term for the fat surrounding the organs—compared to 12% among patients on placebo. Meanwhile, “no more than 10.8%” of change in total tissue mass at the highest survodutide dose suggested that weight loss was “primarily driven by reductions in fat mass,” Boehringer argued in a June 7 release. With survodutide, the German drugmaker believes it has the potential to address the high unmet need of “targeted weight loss,” Vani Manja, head of Boehringer Ingelheim’s obesity and liver health therapeutic area, told Fierce in an interview ahead of the conference.“We want to be playing a role in this shift towards long-term metabolic health, beyond just weight loss and obesity,” she explained. “What you’ve seen at the high level from the topline results, and what we’re presenting at ADA, truly build on that meaningful weight loss alongside data on liver fat, visceral fat, and data on lean mass … that help us better understand the quality of weight loss.”On the lean mass ratio, which represents lean tissue lost versus the total tissue mass patients lost, Manja noted that the 10.8% figure in the trial suggests that “the majority of the weight loss observed was driven by fat loss.” Loss of muscle mass has remained an issue of concern around incretin medicines for chronic weight loss. “These effects are particularly relevant when we talk about metabolic disease, solving metabolic disease and delivering long-term metabolic health,” Manja said. “The number on the scale is only part of the story, and we look now to understand the rest of the story and make an impact there.”While the weight loss figures tracked with previous readouts, tolerability remained a sore spot for survodutide. After topline results from midphase trial several years back revealed that nearly a quarter of patients discontinued the treatment, the CEO of Zealand Pharma—which licensed survodutide to Boehringer—suggested earlier this year that flexible titration and antiemetic drugs could help control side effects in the phase 3 study presented at ADA.  But in detailed results from Synchronize-1 published in The New England Journal of Medicine on Sunday, nearly 24% of patients on the 3.6 mg dose of survodutide and nearly 25% of patients on the higher 6 mg dose discontinued treatment due to an adverse event (AE), versus around 5.4% of patients on placebo. Framed another way in Boehringer’s press release, 19% of patients discontinued treatment with survodutide due to gastrointestinal side effects, specifically in Synchronize-1, compared to 2.9% of patients in the placebo group. Either way, the discontinuation rate does not appear to track favorably with those seen in pivotal trials of Lilly and Novo’s incretin meds for obesity. Wegovy and Zepbound\'s pivotal trials saw discontinuations due to AEs range from 2.6% to 7.1% depending on the dose.“The GLPs have all shown some degree of gastrointestinal symptoms, and I can tell you that our AE profile is consistent with that,” Neerja Balachander, Ph.D., VP of U.S. clinical development, medical affairs and therapeutic area head for cardiorenal metabolic at Boehringer, told Fierce in a separate interview ahead of the conference.To a certain extent, difficulties with gastrointestinal side effects could be ameliorated as health systems figure out how to better support patients taking incretin meds for obesity, Balachander argued. “I do think that it is important for patients to know how to use it, because again, there’s a lot of interest in utilization,” she said. “But I do not think that the healthcare systems yet know how to slowly help these patients with these AEs, and I think that’s something that we at Boehringer are really committed to doing.” A deepening understanding at all levels that obesity is a chronic disease—and not just something for which a person pursues aesthetic weight loss—could also go a long way toward better improving adherence and managing side effects, Balachander added. Additionally, patients need to be proactive when dealing with side effects, “so that you can either up-titrate or down-titrate these drugs,” she said.More remains to be done to educate “the healthcare community, as well as the patients, that these are serious interventions,” she explained. “They give you great effect, but there are some rules that you have to follow,” she said of managing side effect burden through improvements to diet and other factors.  Liver differentiation One area where Boehringer still hopes to have an edge is survodutide\'s effect on the liver. A pre-specified analysis of Synchronize-1 found patients on survodutide charted liver fat reductions of up to 63.1%, compared to 25% in the study’s control cohort. The pharma also used ADA to disclose data on its phase 3 Synchronize-MASLD trial, which assessed the dual agonist in adults with obesity or who were overweight who had metabolic dysfunction-associated steatotic liver disease (MASLD) with evidence of inflammation and or fibrosis. That study recruited patients both with and without type 2 diabetes. Boehringer noted that the trial met the mark, with up to 84.2% of patients on survodutide achieving at least a 30% relative liver fat reduction on the efficacy estimand—representing patients who took their treatment regimen as instructed—versus 24.3% in the placebo arm. On a co-primary endpoint, survodutide was linked to a 12.2% relative reduction in body weight, once more on the efficacy estimand, versus 1% in the control cohort. MASLD is a condition in which excess fat builds up in the liver. Upwards of 75% of people with obesity will develop MASLD, according to Boehringer, and for one in three, the condition can advance to the more serious stage known as metabolic dysfunction-associated steatohepatitis (MASH).Back in April, analysts at William Blair suggested that with little in the standard weight loss data to make Boehringer\'s drug stand out from approved options, survodutide’s “potential differentiation could derive from its liver-related benefit.”