MetaVia (NASDAQ: MTVA) advances DA-1726 obesity program with IRB-approved higher-dose Phase 1 trial
Rhea-AI Filing Summary
MetaVia Inc. filed an 8-K to report that an Institutional Review Board at Clinical Pharmacology of Miami has approved Phase 1 Part 3 of its obesity trial for lead drug DA-1726, a dual GLP-1 and glucagon receptor agonist. The 16-week study will enroll 40 obese but otherwise healthy adults in two cohorts, testing one-step titration up to 48 mg and two-step titration up to 64 mg. It will track safety, side effects, pharmacokinetics, and multiple metabolic and body composition measures. MetaVia plans to begin dosing in April 2026 and expects data in the fourth quarter of 2026, building on earlier Phase 1 results where the 48 mg dose produced about 9% weight loss and improved glucose and waist measures.
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Insights
IRB approval advances MetaVia’s obesity program into higher-dose Phase 1 testing.
MetaVia received IRB approval to start Phase 1 Part 3 studies of DA-1726, a dual GLP-1/glucagon agonist for obesity. Two 16-week titration regimens will explore higher doses of 48 mg and 64 mg in 40 obese, otherwise healthy adults.
The trial focuses on safety, tolerability, pharmacokinetics, and pharmacodynamics, with primary endpoints centered on adverse events. Secondary and exploratory measures include weight, waist circumference, body mass index, and broader cardiometabolic markers, aligning with obesity and metabolic disease targets.
Management highlights earlier Phase 1 data where a 48 mg dose achieved approximately 9% weight loss and improved glycemic and waist metrics. With dosing planned to begin in April 2026 and data expected in Q4 2026, subsequent disclosures will clarify whether higher doses maintain tolerability while enhancing efficacy.
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FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosures.
On March 18, 2026, MetaVia Inc. (the “Company”) issued a press release announcing that the Institutional Review Board at Clinical Pharmacology of Miami has approved the Company’s Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is incorporated herein by reference.
Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Report, and the inclusion of such website addresses in this Report by incorporation by reference of the press release is as inactive textual references only.
The information in Item 7.01 of this Report, including Exhibit 99.1 attached hereto, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Item 8.01. Other Events.
On March 18, 2026, the Company issued a press release announcing that the Institutional Review Board at Clinical Pharmacology of Miami has approved the Company’s Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin analog agonist targeting both GLP-1 and glucagon receptors. The Phase 1 Part 3 trial will enroll a total of 40 obese, otherwise healthy adult subjects, across two parts, with 20 subjects per part, randomized 4:1 (16 active; 4 placebo). Part 3A is designed to evaluate a one-step titration regimen with 16 mg for 4 weeks followed by 48 mg for 12 weeks, while Part 3B will evaluate a two-step titration regimen with 16 mg for 4 weeks, 32 mg for 4 weeks, and 64 mg for 8 weeks. The study will assess safety, tolerability, pharmacokinetics (“PK”), and pharmacodynamics of DA-1726. Primary endpoints include monitoring adverse events (“AEs”), serious adverse events, treatment-emergent adverse events, and AEs leading to treatment discontinuation. Secondary and exploratory endpoints include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index, and other cardiometabolic measures. The Company plans to initiate initial dosing in April 2026, with data expected in the fourth quarter of 2026.
Forward-Looking Statements
This Report, including Exhibit 99.1 attached hereto, contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit |
| Exhibit Description |
99.1 | Press Release dated March 18, 2026. | |
104 | Cover Page Interactive Data File (embedded within Inline XBRL document). |
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| METAVIA INC. | ||
Date: March 18, 2026 | By: | /s/ Hyung Heon Kim | |
Hyung Heon Kim | |||
President and Chief Executive Officer | |||
Exhibit 99.1
MetaVia Advances GLP-1-Based Obesity Program with IRB Approval for Higher-Dose Phase 1 Studies of DA-1726, a GLP-1 and Glucagon Dual Agonist Demonstrating Best-in-Class Potential for Weight Loss and Glucose Control
16-Week Study to Evaluate One-Step Dose Titration to 48 mg and Two-Step Dose Titration to 64 mg in Obese Otherwise Healthy Adults
CAMBRIDGE, Mass., March 18, 2026 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the Institutional Review Board (IRB) at Clinical Pharmacology of Miami has approved the Company’s Phase 1 Part 3 clinical trial of its lead asset, DA-1726, a novel, dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors. The approval enables initiation of Part 3 of the Phase 1 program, which consists of two 16-week titration cohorts evaluating one-step and two-step dose-escalation strategies intended to safely reach higher target doses and further optimize tolerability.
The Phase 1 Part 3 trial will enroll a total of 40 obese, otherwise healthy adult subjects, across two parts, with 20 subjects per part, randomized 4:1 (16 active; 4 placebo). Part 3A is designed to evaluate a one-step titration regimen with 16 mg for 4 weeks followed by 48 mg for 12 weeks, while Part 3B will evaluate a two-step titration regimen with 16 mg for 4 weeks, 32 mg for 4 weeks, and 64 mg for 8 weeks. The study will assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726. Primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs leading to treatment discontinuation. Secondary and exploratory endpoints include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index (BMI), and other cardiometabolic measures.
“This IRB approval marks a key milestone in the advancement of DA-1726 and builds on the program’s increasingly compelling clinical profile across efficacy, safety, and tolerability,” stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “In earlier cohorts, the 48 mg dose produced approximately 9% weight loss, meaningful reductions in waist circumference, improved blood sugar control, and early signals of direct liver benefit, all with a favorable safety profile. Our upcoming 16-week titration studies to 48 mg and 64 mg doses are designed to build on these results and further highlight DA-1726’s favorable tolerability and potential advantage relative to currently marketed therapies that require slower, more extended titration before achieving full therapeutic dosing. With initial dosing expected to begin in April and data expected in the fourth quarter of 2026, we believe these results will further de-risk the program and support advancement of DA-1726 into later-stage development, reinforcing its potential as a differentiated, next-generation GLP-1-based therapy that could offer meaningful advantages over existing options.”
About DA-1726
DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a 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 pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in pre-clinical 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 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 novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects.
For more information, please visit www.metaviatx.com.
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 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 pre-clinical 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
marshall.woodworth@metaviatx.com
Rx Communications Group
Michael Miller
+1-917-633-6086
mmiller@rxir.com
FAQ
What did MetaVia (MTVA) announce in its latest 8-K filing?
MetaVia announced Institutional Review Board approval for Phase 1 Part 3 of DA-1726, its lead obesity drug. The new 16-week study will test higher-dose titration regimens, focusing on safety, tolerability, and detailed metabolic and body composition outcomes in obese adults.
What is MetaVia’s DA-1726 and what does it target?
DA-1726 is a novel oxyntomodulin analogue acting as a dual agonist of GLP-1 and glucagon receptors. It is being developed for obesity and Metabolic Dysfunction-Associated Steatohepatitis, aiming to reduce appetite, increase energy expenditure, and improve weight, glucose control, and cardiometabolic measures.
How is MetaVia’s Phase 1 Part 3 DA-1726 trial designed?
The Phase 1 Part 3 trial will enroll 40 obese, otherwise healthy adults, split into two 16-week cohorts. Regimens test one-step titration to 48 mg and two-step titration to 64 mg, with subjects randomized 4:1 to active drug versus placebo to evaluate safety and pharmacologic profiles.
What endpoints will MetaVia measure in the DA-1726 Phase 1 Part 3 study?
Primary endpoints track adverse events, serious adverse events, treatment-emergent events, and discontinuations. Secondary and exploratory endpoints include pharmacokinetics and changes in weight, waist circumference, body mass index, glycemic control, lipid levels, and broader cardiometabolic and body composition parameters.
When does MetaVia expect dosing and data from the DA-1726 Phase 1 Part 3 trial?
MetaVia plans to initiate initial dosing in April 2026, following IRB approval at Clinical Pharmacology of Miami. The company currently expects topline data from this 16-week higher-dose study in the fourth quarter of 2026, subject to trial conduct and enrollment.
What prior DA-1726 results did MetaVia highlight in this disclosure?
MetaVia cited earlier Phase 1 multiple ascending dose results where a 48 mg dose of DA-1726 achieved about 9% weight loss. Those data also showed reductions in waist circumference, improved blood sugar control, and early signs of liver benefit with a favorable safety profile.
Filing Exhibits & Attachments
4 documentsPress Releases
