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MetaVia Reports Positive Statistically Significant Results from Its Phase 1b Clinical Trial of DA-1726 In Metabolic Disease - Demonstrating Strong Glycemic Response, Significant Direct Hepatic Effects, Robust Weight Loss and Favorable Safety Profile

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MetaVia (Nasdaq: MTVA) reported positive Phase 1b results for DA-1726 from an 8-week non-titrated 48 mg cohort, showing early and statistically significant metabolic effects by Day 54.

Key results: weight -9.1% (21.2 lbs), waist -9.8 cm (p=0.022), fasted glucose -12.3 mg/dL, and liver stiffness -23.7% (VCTE); no treatment-related discontinuations and mainly mild-to-moderate GI events. The company plans 16-week titration studies with results expected in Q4 2026.

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Positive

  • Weight -9.1% (21.2 lbs) by Day 54
  • Waist circumference -9.8 cm by Day 54 (p=0.022)
  • Fasted glucose -12.3 mg/dL by Day 54
  • Liver stiffness -23.7% by Day 54 (VCTE)
  • No treatment-related discontinuations; tolerability favorable

Negative

  • Small cohort size: 9 subjects per cohort (6:3 randomization)
  • Data limited to an 8-week non-titrated cohort; longer-term effects unknown

News Market Reaction – MTVA

-8.68%
8 alerts
-8.68% News Effect
-10.5% Trough in 8 hr 51 min
-$2M Valuation Impact
$21M Market Cap
0.2x Rel. Volume

On the day this news was published, MTVA declined 8.68%, reflecting a notable negative market reaction. Argus tracked a trough of -10.5% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $21M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Waist reduction Day 54: 9.8 cm (p=0.022) Weight loss Day 54: 9.1% (21.2 lbs) Weight loss Day 26: 6.1% (14.6 lbs), p=0.003 +5 more
8 metrics
Waist reduction Day 54 9.8 cm (p=0.022) Non-titrated 48 mg DA-1726 cohort, Phase 1b obesity trial
Weight loss Day 54 9.1% (21.2 lbs) Non-titrated 48 mg DA-1726 cohort, 8-week exposure
Weight loss Day 26 6.1% (14.6 lbs), p=0.003 Non-titrated 48 mg DA-1726 cohort
Fasted glucose change −12.3 mg/dL from 105.3 mg/dL By Day 54 on DA-1726
Liver stiffness change −23.7% from 5.9 kPa VCTE measurement by Day 54 on DA-1726
HbA1c change 6.0% to 5.5% Prediabetic subject by Day 54 on DA-1726
BMI eligibility 30–45 kg/m² Obese but otherwise healthy adults in Phase 1 trial
Randomization ratio 6:3 (DA-1726:placebo), 9 subjects/cohort Phase 1 trial design with weekly administrations

Market Reality Check

Price: $1.55 Vol: Volume 21,032 is only 0.0...
low vol
$1.55 Last Close
Volume Volume 21,032 is only 0.08x the 20-day average of 253,705, indicating limited pre-news positioning. low
Technical Shares traded slightly above the 200-day MA, with price at $9.56 vs MA-200 at $9.36 before this news.

Peers on Argus

Peer performance was mixed: LPCN appeared in momentum down ~5%, while other biot...
1 Down

Peer performance was mixed: LPCN appeared in momentum down ~5%, while other biotech peers in the list showed a range of small gains and losses, suggesting MTVA’s move was more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Dec 29 (Neutral)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 29 Conference participation Neutral -2.1% Highlighted upcoming MASH-TAG 2026 presence without new financial or clinical data.
Dec 22 Listing compliance Positive +11.6% Regained compliance with Nasdaq minimum bid price and closed related listing matter.
Dec 02 Reverse stock split Negative -20.1% 1-for-11 reverse split to address listing requirements and reduce outstanding shares.
Nov 07 Clinical data update Positive +6.8% Positive Phase 2a vanoglipel data in presumed MASH with HbA1c and liver benefits.
Nov 06 Earnings and pipeline Negative -15.0% Q3 2025 results with going-concern language alongside DA-1726 and DA-1241 updates.
Pattern Detected

Price has generally moved in the same direction as the perceived tone of past news, including sizeable reactions to capital structure and clinical updates.

Recent Company History

Over the last six months, MetaVia has alternated between corporate housekeeping and pipeline milestones. A 1-for-11 reverse split and ongoing Nasdaq compliance efforts framed balance-sheet and listing risk, while Q3 2025 results highlighted constrained cash of $14.3M and a going-concern warning. In parallel, repeated positive updates on DA-1726 and vanoglipel, including Phase 1 and Phase 2a efficacy signals, supported the cardiometabolic strategy. Today’s Phase 1b DA-1726 data extend those earlier weight-loss and metabolic benefits over 8 weeks, building directly on prior shorter-duration MAD cohorts.

Market Pulse Summary

The stock moved -8.7% in the session following this news. A negative reaction despite favorable Phas...
Analysis

The stock moved -8.7% in the session following this news. A negative reaction despite favorable Phase 1b efficacy and safety data would fit a pattern where structural and financing concerns occasionally outweighed clinical progress. MetaVia previously flagged substantial doubt about its ability to continue as a going concern and put an at-the-market program in place, which can sensitize investors to dilution and funding risk even when trial results are statistically significant and directionally positive.

Key Terms

oxyntomodulin, glucagon-like peptide-1 receptor, glucagon receptor, vibration-controlled transient elastography, +4 more
8 terms
oxyntomodulin medical
"DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as..."
Oxyntomodulin is a naturally occurring gut hormone released after eating that reduces appetite and influences blood sugar and energy use, acting like a thermostat that helps dial down hunger and adjust the body's fuel handling. It matters to investors because drugs that mimic or boost this hormone are a major class of experimental treatments for obesity and diabetes; trial results, safety findings, and regulatory decisions around oxyntomodulin-based therapies can strongly affect company value and market opportunity.
glucagon-like peptide-1 receptor medical
"functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor..."
A glucagon-like peptide-1 (GLP-1) receptor is a protein on the surface of certain cells—especially in the pancreas and brain—that acts like a lock for the natural GLP-1 hormone, triggering signals that lower blood sugar and reduce appetite when activated. It matters to investors because many diabetes and weight-loss drugs are designed to fit this “lock,” so trial results, approvals, or new competitors targeting the receptor can strongly affect drug sales and company value.
glucagon receptor medical
"functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR)..."
A glucagon receptor is a protein on the surface of certain cells that acts like a lock for the hormone glucagon, which is a key that signals the body to release stored sugar into the bloodstream. Investors care because drugs that block or activate this receptor can change blood sugar, weight and metabolism—so success or failure in developing such drugs can materially affect a biotech company’s value and market prospects.
vibration-controlled transient elastography medical
"vibration-controlled transient elastography (VCTE) indicated a 23.7% reduction..."
A noninvasive imaging test that measures tissue stiffness by sending a gentle vibration into the body and timing the resulting wave, commonly used to assess liver scarring (fibrosis). For investors, it matters because stiffness readings serve as a fast, low-risk biomarker that can indicate disease progression or treatment effect without a biopsy, influencing demand for diagnostic devices, clinical trial endpoints, and the market value of therapeutics targeting liver disease.
hba1c medical
"early HbA1c benefits, such as a drop from 6.0% to 5.5% by day 54..."
A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.
body mass index medical
"adults with a body mass index (BMI) of 30–45 kg/m²."
Body mass index (BMI) is a simple number calculated from a person’s weight and height that gives a rough measure of whether their body size is underweight, normal, overweight, or obese, similar to using a single score to gauge whether a container is underfilled or overfilled. Investors care because average BMI trends affect demand and costs in healthcare, insurance, and consumer markets, and can signal population health risks that influence long-term revenues and liabilities.
pharmacokinetics medical
"designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD)..."
Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.
pharmacodynamics medical
"designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD)..."
Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

AI-generated analysis. Not financial advice.

Statistically Significant (p=0.006) Waist Circumference Reduction of 9.8 cm at Day 54

Significant Direct Hepatic Activity with a 23.7% Reduction in Liver Stiffness (VCTE) by Day 54

Strong Glycemic Response with a 12.3 mg/dL Fasted Glucose Reduction by Day 54

Robust Weight Loss with 9.1% Reduction (21.2 lbs) by Day 54

CAMBRIDGE, Mass., Jan. 5, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive statistically significant results from the 8-week (extended from four weeks) non-titrated 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The results show robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, alongside a favorable safety and tolerability profile.

In the non-titrated 48 mg cohort, patients experienced no treatment-related discontinuations, and gastrointestinal events were mild to moderate in severity. By Day 26, patients receiving DA-1726 achieved a statistically significant average weight reduction of 6.1% (14.6 lbs.) (p=0.003) and a statistically significant decrease in waist circumference of 5.8 cm (2.3 inches) (p=0.006). These improvements deepened through Day 54, with an average weight loss of 9.1% (21.2 lbs.) and a statistically significant 9.8 cm (3.8 inch) (p=0.022) reduction in waist circumference. Patients also demonstrated a 12.3 mg/dL improvement in fasted glucose from a baseline of 105.3 mg/dL by Day 54. In addition, vibration-controlled transient elastography (VCTE) indicated a 23.7% reduction in liver stiffness from a baseline of 5.9 kPa, suggesting a significant direct hepatic effect from DA-1726.

"Extending DA-1726 administration to a full eight weeks at the non-titrated 48 mg dose has provided us with extremely encouraging insights," said Hyung Heon Kim, president and chief executive officer of MetaVia. "Patients in this cohort achieved a statistically significant 6.1% weight loss by Day 26 and 9.1% by Day 54, along with reductions in waist circumference of 5.8 cm and 9.8 cm at those same time points. We believe the statistically significant waist reductions reflect the glucagon component of DA-1726, which may contribute to deeper visceral fat loss than GLP-1 agonists alone. Combined with a favorable tolerability profile with no treatment-related discontinuations, these results highlight DA-1726's differentiated potential to be a best-in-class treatment option."

"We also observed meaningful metabolic improvements, including a 12.3 mg/dL reduction in fasted glucose and early HbA1c benefits, such as a drop from 6.0% to 5.5% by day 54, in a prediabetic subject. These findings are especially important because the vast majority of people with obesity—ranging from 70% to 80%—have diabetes or prediabetes, and diabetic patients typically receive broader insurance coverage for anti-obesity therapies. DA-1726 has the potential to be the most effective GLP-1/glucagon dual agonist in development that has demonstrated glucose lowering without elevations, which may offer both clinical and reimbursement advantages. Because VCTE is the leading noninvasive tool for liver stiffness assessment and is recognized by the FDA as a biomarker in MASH development, seeing a 23.7% reduction in only eight weeks underscores the hepatic potential of DA-1726. Taken together, the data reinforce our view that DA-1726 has best-in-class potential, delivering a compelling balance of weight loss, metabolic improvement, direct hepatic benefit, and tolerability as we advance toward later-stage development."

Mr. Kim added, "Looking ahead, our planned 16-week titration studies—to 48 mg in a single step and to 64 mg using a two-step regimen—reflect our confidence in DA-1726's tolerability and our expectation that it will compare favorably to the slower, more restrictive titration schedules required by today's GLP-1 drugs. We believe this represents a key competitive advantage. With results expected in the fourth quarter of 2026, we are well positioned to unlock further value creation as we continue advancing DA-1726 toward later-stage development."

The Phase 1 trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese but otherwise healthy adults with a body mass index (BMI) of 30–45 kg/m². Nine subjects in each cohort were randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort added 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary objective was to assess safety and tolerability based on adverse events (AEs), serious adverse events (SAEs), treatment-emergent events (TAEs), and discontinuations. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.

For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.

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®). 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 GLP1R agonists. 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, which include, among other statements, statements regarding the timing and release of data related to the company's planned 16-week titration studies. 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 ability to execute on its commercial strategy; MetaVia's expectations regarding the sufficiency of its existing cash on hand to fund MetaVia's operations; 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 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 or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; 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 and subsequent Quarterly Reports on Form 10-Q. 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 Phase 1b results did MetaVia (MTVA) announce for DA-1726 on January 5, 2026?

MetaVia announced Day 54 results showing weight -9.1%, waist -9.8 cm (p=0.022), fasted glucose -12.3 mg/dL, and liver stiffness -23.7% with favorable tolerability.

How significant was the waist circumference change for MTVA's DA-1726 and when was it measured?

Waist circumference fell an average of 9.8 cm by Day 54 in the 48 mg non-titrated cohort (statistically significant, p=0.022).

What safety and tolerability did MetaVia report for DA-1726 in the 48 mg cohort?

No treatment-related discontinuations were reported; gastrointestinal events were described as mild to moderate in severity.

Did DA-1726 show any liver-related benefits in MetaVia's Phase 1b data?

Yes; vibration-controlled transient elastography showed a 23.7% reduction in liver stiffness by Day 54, suggesting a direct hepatic effect.

What are MetaVia's next clinical plans and timing for DA-1726 (MTVA)?

MetaVia plans 16-week titration studies (to 48 mg single-step and to 64 mg two-step) with results expected in Q4 2026.

How large were the cohorts in MetaVia's Phase 1 trial for DA-1726?

Cohorts were randomized with 9 subjects each in a 6:3 active-to-placebo ratio.
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