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
Rhea-AI Summary
MetaVia (Nasdaq: MTVA) received IRB approval to start Phase 1 Part 3 testing of DA-1726, a dual GLP-1/glucagon oxyntomodulin analog, in obese adults.
The 16-week cohorts (one-step to 48 mg; two-step to 64 mg) will enroll 40 subjects total, assess safety, PK/PD, metabolic and body-composition measures, with dosing starting in April and data expected in Q4 2026.
Positive
- Approx. 9% weight loss observed at 48 mg in earlier cohorts
- Phase 1 Part 3 enrollment of 40 subjects (2 cohorts of 20)
- Higher-dose testing to 48 mg and 64 mg to evaluate efficacy/tolerability
- Data timeline: initial dosing expected in April; data expected Q4 2026
Negative
- Small sample size: Part 3 enrolls only 40 subjects total
- Primary endpoints focus on safety/tolerability; efficacy measures are secondary
- Later-stage proof needed: results from Phase 1 required before pivotal studies
News Market Reaction – MTVA
On the day this news was published, MTVA declined 2.63%, reflecting a moderate negative market reaction. Argus tracked a peak move of +5.7% during that session. Argus tracked a trough of -5.9% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $132K from the company's valuation, bringing the market cap to $5M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peer moves are mixed, with some biotech names up and others down, and scanner activity split between one stock up and one down, pointing to stock-specific drivers rather than a coordinated sector move.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 05 | Phase 1b results | Positive | -8.7% | Reported statistically significant 48 mg Phase 1b metabolic and weight loss data. |
| Aug 06 | Phase 1 extension | Positive | +2.9% | Extended 48 mg MAD cohort to 8 weeks to study longer-term efficacy and safety. |
| Jul 09 | 48 mg dosing start | Positive | +8.2% | Dosed first patient in 48 mg MAD cohort to further explore maximum tolerated dose. |
| Jun 21 | Preclinical combo data | Positive | -0.9% | Presented DA-1241 plus EFX preclinical data showing enhanced hepatoprotective effects in MASH. |
| Apr 22 | MAD Part 2 results | Positive | +2.4% | Disclosed additional positive MAD results for DA-1726 with dose-dependent weight loss and good safety. |
Clinical trial updates for DA-1726 and DA-1241 have often been positive, but price reactions have been mixed, with both rallies and selloffs following similar clinical milestones.
Over the past year, MetaVia has steadily advanced its cardiometabolic pipeline. Multiple Phase 1 updates for DA-1726 showed dose-dependent weight loss, favorable safety, and plans to explore higher doses. Positive Phase 1b data on a 48 mg cohort highlighted robust weight and liver benefits, while DA-1241 generated encouraging preclinical and clinical signals in MASH. Today’s IRB approval for a higher-dose Phase 1 Part 3 obesity study fits this ongoing development arc and moves DA-1726 closer to later-stage trials.
Historical Comparison
Past clinical-trial updates for MetaVia moved the stock by an average of 0.79%, suggesting historically modest reactions even to meaningful DA-1726 data.
Clinical news traces DA-1726 from early MAD cohorts through 48 mg extensions and Phase 1b data to today’s IRB-cleared Part 3 titration study, indicating steady progression toward later-stage obesity development.
Market Pulse Summary
This announcement advances MetaVia’s obesity program by enabling 16-week Phase 1 Part 3 titration cohorts of DA-1726 up to 48 mg and 64 mg, building on earlier data showing around 9% weight loss at 48 mg. It extends a sequence of DA-1726 milestones and comes after capital raises that fund operations into 2026. Investors may watch enrollment progress, safety and tolerability at higher doses, and the planned Q4 2026 readout as key future catalysts.
Key Terms
institutional review board (irb) regulatory
oxyntomodulin medical
pharmacokinetics (pk) medical
pharmacodynamics (pd) medical
adverse events (aes) medical
serious adverse events (saes) medical
treatment-emergent adverse events (teaes) medical
body mass index (bmi) medical
AI-generated analysis. Not financial advice.
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
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
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
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SOURCE MetaVia Inc.
FAQ
What is MetaVia (MTVA) announcing about the Phase 1 Part 3 trial for DA-1726?
How many subjects will MetaVia (MTVA) enroll in the DA-1726 Phase 1 Part 3 study and how are they randomized?
What dosing regimens will MetaVia (MTVA) test in the DA-1726 Part 3 study?
When does MetaVia (MTVA) expect dosing and data readout for the DA-1726 Part 3 study?
What endpoints will MetaVia (MTVA) evaluate in the DA-1726 Phase 1 Part 3 trial?
