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

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.

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

Argus Mar 18 session

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Details

News Market Reaction – MTVA

In the Mar 18 session, MTVA declined 2.63%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances MetaVia’s obesity program by enabling 16-week Phase 1 Part 3 titration co...

Analysis

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 Figures

Study duration: 16 weeks Target doses: 48 mg and 64 mg Sample size: 40 subjects +5 more

Study duration

16 weeks

Phase 1 Part 3 titration cohorts for DA-1726

Target doses

48 mg and 64 mg

Higher-dose Phase 1 Part 3 DA-1726 titration arms

Sample size

40 subjects

Obese otherwise healthy adults in Phase 1 Part 3 trial

Randomization ratio

4:1 (16 active; 4 placebo)

Per 20-subject part in Phase 1 Part 3 trial

One-step regimen

16 mg 4 weeks → 48 mg 12 weeks

Part 3A titration schedule

Two-step regimen

16 mg 4 weeks → 32 mg 4 weeks → 64 mg 8 weeks

Part 3B titration schedule

Weight loss

≈9%

Earlier 48 mg cohort DA-1726 Phase 1 data

Data timeline

Q4 2026

Expected readout from 16-week DA-1726 titration studies

Previous Clinical trial Reports

5 past events · Latest: Jan 05

Same Type 5 events

1. Jan 05

   Phase 1b results

   24h Move

   -8.7%

   Reported statistically significant 48 mg Phase 1b metabolic and weight loss data.

2. Aug 06

   Phase 1 extension

   24h Move

   +2.9%

   Extended 48 mg MAD cohort to 8 weeks to study longer-term efficacy and safety.

3. Jul 09

   48 mg dosing start

   24h Move

   +8.2%

   Dosed first patient in 48 mg MAD cohort to further explore maximum tolerated dose.

4. Jun 21

   Preclinical combo data

   24h Move

   -0.9%

   Presented DA-1241 plus EFX preclinical data showing enhanced hepatoprotective effects in MASH.

5. Apr 22

   MAD Part 2 results

   24h Move

   +2.4%

   Disclosed additional positive MAD results for DA-1726 with dose-dependent weight loss and good safety.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

institutional review board (irb), oxyntomodulin, pharmacokinetics (pk), pharmacodynamics (pd), +4 more

8 terms

institutional review board (irb) regulatory

"the Institutional Review Board (IRB) at Clinical Pharmacology of Miami has approved"

An institutional review board (IRB) is an independent committee that reviews and approves research involving people to make sure studies are safe, ethical, and that participants give informed consent. For investors, IRB approval is like a safety inspection for a company’s clinical program: it can reduce regulatory risk, affect how quickly trials start or proceed, and influence whether study results will be accepted by regulators, all of which can change a company’s value and outlook.

oxyntomodulin medical

"a novel, dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon"

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.

pharmacokinetics (pk) medical

"The study will assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics"

Pharmacokinetics (PK) is the study of how a drug moves through and is processed by the body over time. It tracks how quickly a drug is absorbed, how it spreads, how it is broken down, and how it exits the body—similar to following a recipe’s ingredients from start to finish. For investors, understanding pharmacokinetics helps assess a drug’s effectiveness and safety, which can influence its market potential and valuation.

pharmacodynamics (pd) medical

"The study will assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)"

Pharmacodynamics (PD) is the study of how a drug affects the body and how the body's response changes with different drug doses. It explains how medications work to produce their effects, similar to how a thermostat controls room temperature. Understanding PD helps investors evaluate the potential effectiveness and risks of drugs, influencing decisions in the healthcare and pharmaceutical sectors.

adverse events (aes) medical

"Primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs)"

Adverse events (AEs) are any unwanted medical problems or side effects that occur in people taking a drug, vaccine, or undergoing a medical procedure, whether or not the treatment caused them. Think of AEs like warning lights on a dashboard: a few minor blips may be manageable, but frequent or serious lights can signal bigger problems that affect patient safety, regulatory approvals, and a product’s commercial prospects — all key concerns for investors.

serious adverse events (saes) medical

"Primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs)"

Serious adverse events (SAEs) are significant negative outcomes, such as severe health issues, hospitalizations, or death, that occur during a medical study or treatment. For investors, SAEs matter because they can signal potential risks associated with a product or company, potentially affecting its reputation, regulatory approval, or financial performance. Recognizing SAEs helps gauge the safety and reliability of medical-related investments.

treatment-emergent adverse events (teaes) medical

"treatment-emergent adverse events (TEAEs), and AEs leading to treatment discontinuation"

Adverse events that first appear or worsen after a patient starts a medical treatment; they are the new or intensified negative effects linked in time to taking the drug or therapy. Investors care because the number and severity of these events shape regulators’ decisions, drug labeling, patient uptake and potential legal or cost risks—think of them like customer complaints that can slow sales, trigger recalls, or change a product’s value.

body mass index (bmi) medical

"including weight, waist circumference, and body mass index (BMI), and other cardiometabolic"

Body mass index (BMI) is a simple number calculated from a person’s weight and height that gives a rough indication of whether their body size falls into categories such as underweight, normal, overweight, or obese. For investors, BMI matters because it’s a common screening measure used in public health, insurance underwriting, clinical trials and market research; shifts in population BMI can affect demand for medical services, drugs, insurance costs and related business risks, like a quick fuel-gauge that signals broader health trends.

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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 /PRNewswire/ -- 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

 

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SOURCE MetaVia Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is MetaVia (MTVA) announcing about the Phase 1 Part 3 trial for DA-1726?

The company received IRB approval to start two 16-week cohorts testing one-step and two-step titration to 48 mg and 64 mg. According to MetaVia, the trial will enroll 40 obese adults and assess safety, PK/PD, and metabolic endpoints.

How many subjects will MetaVia (MTVA) enroll in the DA-1726 Phase 1 Part 3 study and how are they randomized?

The study will enroll 40 obese, otherwise healthy adults, randomized 4:1 (16 active; 4 placebo) per cohort. According to MetaVia, there are two parts with 20 subjects each.

What dosing regimens will MetaVia (MTVA) test in the DA-1726 Part 3 study?

Part 3A uses a one-step titration (16 mg for 4 weeks, then 48 mg for 12 weeks); Part 3B uses two-step titration to 64 mg. According to MetaVia, both regimens are 16-week titration cohorts.

When does MetaVia (MTVA) expect dosing and data readout for the DA-1726 Part 3 study?

Initial dosing is expected to begin in April, with data expected in the fourth quarter of 2026. According to MetaVia, the timeline targets a Q4 2026 data readout to inform later-stage planning.

What endpoints will MetaVia (MTVA) evaluate in the DA-1726 Phase 1 Part 3 trial?

Primary endpoints focus on safety: AEs, SAEs, TEAEs, and AEs leading to discontinuation; secondary/exploratory endpoints include PK profiling and metabolic measures. According to MetaVia, weight, waist circumference, BMI, and glycemic/lipid metrics will be assessed.