MetaVia Doses First Patient in the 48 mg MAD Cohort of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity to Further Explore Maximum Tolerated Dose
MetaVia (NASDAQ:MTVA) has initiated dosing in the 48 mg multiple ascending dose (MAD) cohort of its Phase 1 clinical trial for DA-1726, a novel dual oxyntomodulin analog agonist targeting obesity treatment. The trial's top-line data is expected in Q4 2025.
Previously reported data from the 32 mg dose showed promising results, including dose-dependent weight loss of 4.3% (mean) and 6.3% (max) by Day 26, with 83% of patients reporting early satiety. The drug demonstrated favorable cardiovascular safety and mild gastrointestinal side effects, potentially offering advantages over existing GLP-1 therapies that face high discontinuation rates.
The Phase 1 trial is studying safety, tolerability, and pharmacokinetics in obese subjects with BMI 30-45 kg/m², with subjects receiving 4 weekly administrations in a 6:3 randomization ratio.
MetaVia (NASDAQ:MTVA) ha iniziato la somministrazione nella coorte da 48 mg a dosi multiple ascendenti (MAD) del suo studio clinico di Fase 1 per DA-1726, un nuovo agonista duale dell'ossintomodulina mirato al trattamento dell'obesità. I dati principali dello studio sono attesi per il quarto trimestre 2025.
I dati precedentemente riportati per la dose da 32 mg hanno mostrato risultati promettenti, inclusa una perdita di peso dipendente dalla dose del 4,3% (media) e del 6,3% (massima) entro il giorno 26, con il 83% dei pazienti che ha riferito sazietà precoce. Il farmaco ha dimostrato una sicurezza cardiovascolare favorevole e lievi effetti collaterali gastrointestinali, offrendo potenzialmente vantaggi rispetto alle terapie GLP-1 esistenti, che presentano elevate percentuali di interruzione.
Lo studio di Fase 1 valuta sicurezza, tollerabilità e farmacocinetica in soggetti obesi con BMI tra 30 e 45 kg/m², con somministrazioni settimanali per 4 settimane in un rapporto di randomizzazione 6:3.
MetaVia (NASDAQ:MTVA) ha iniciado la dosificación en la cohorte de dosis múltiples ascendentes (MAD) de 48 mg de su ensayo clínico de Fase 1 para DA-1726, un nuevo agonista dual del análogo de oxintomodulina dirigido al tratamiento de la obesidad. Se esperan los datos principales del estudio en el cuarto trimestre de 2025.
Los datos previamente reportados de la dosis de 32 mg mostraron resultados prometedores, incluyendo una pérdida de peso dependiente de la dosis del 4,3% (media) y 6,3% (máximo) para el día 26, con el 83% de los pacientes reportando saciedad temprana. El medicamento demostró una seguridad cardiovascular favorable y efectos secundarios gastrointestinales leves, ofreciendo potencialmente ventajas sobre las terapias GLP-1 existentes que presentan altas tasas de abandono.
El ensayo de Fase 1 estudia la seguridad, tolerabilidad y farmacocinética en sujetos obesos con IMC entre 30 y 45 kg/m², con administraciones semanales durante 4 semanas en una proporción de aleatorización 6:3.
MetaVia (NASDAQ:MTVA)가 비만 치료를 목표로 하는 새로운 이중 옥신토모듈린 유사체 작용제 DA-1726의 1상 임상시험 48mg 다회 용량 상승(MAD) 코호트 투여를 시작했습니다. 임상시험의 주요 결과는 2025년 4분기에 발표될 예정입니다.
이전에 보고된 32mg 용량 데이터는 26일차까지 용량 의존적 체중 감소 평균 4.3%, 최대 6.3%를 보였으며, 83%의 환자가 조기 포만감을 보고했습니다. 이 약물은 우수한 심혈관 안전성과 경미한 위장 부작용을 나타내어, 높은 중단율을 보이는 기존 GLP-1 치료제 대비 장점이 있을 것으로 기대됩니다.
1상 시험은 BMI 30-45 kg/m²의 비만 환자를 대상으로 안전성, 내약성 및 약동학을 평가하며, 6:3 무작위 배정 비율로 4주간 매주 투여합니다.
MetaVia (NASDAQ:MTVA) a commencé l'administration dans la cohorte à doses multiples ascendantes (MAD) de 48 mg de son essai clinique de phase 1 pour DA-1726, un nouvel agoniste analogique dual de l'oxyntomoduline ciblant le traitement de l'obésité. Les données principales de l'étude sont attendues au 4e trimestre 2025.
Les données précédemment rapportées pour la dose de 32 mg ont montré des résultats prometteurs, notamment une perte de poids dépendante de la dose de 4,3 % en moyenne et jusqu'à 6,3 % au jour 26, avec 83 % des patients rapportant une satiété précoce. Le médicament a démontré une sécurité cardiovasculaire favorable et des effets secondaires gastro-intestinaux légers, offrant potentiellement des avantages par rapport aux thérapies GLP-1 existantes qui présentent des taux élevés d'arrêt.
L'essai de phase 1 étudie la sécurité, la tolérabilité et la pharmacocinétique chez des sujets obèses avec un IMC de 30 à 45 kg/m², les sujets recevant 4 administrations hebdomadaires selon un ratio de randomisation de 6:3.
MetaVia (NASDAQ:MTVA) hat mit der Dosierung in der 48 mg Multiple Ascending Dose (MAD) Kohorte seiner Phase-1-Studie für DA-1726 begonnen, einem neuartigen dualen Oxyntomodulin-Analogon-Agonisten zur Behandlung von Adipositas. Die wichtigsten Studiendaten werden im 4. Quartal 2025 erwartet.
Frühere Daten der 32 mg Dosis zeigten vielversprechende Ergebnisse, darunter eine dosisabhängige Gewichtsabnahme von durchschnittlich 4,3 % und maximal 6,3 % bis Tag 26, wobei 83 % der Patienten über frühes Sättigungsgefühl berichteten. Das Medikament zeigte eine günstige kardiovaskuläre Sicherheit und milde gastrointestinale Nebenwirkungen, was potenzielle Vorteile gegenüber bestehenden GLP-1-Therapien mit hohen Abbruchraten bietet.
Die Phase-1-Studie untersucht Sicherheit, Verträglichkeit und Pharmakokinetik bei adipösen Probanden mit einem BMI von 30-45 kg/m², wobei die Teilnehmer 4 Wochen lang wöchentlich in einem 6:3-Randomisierungsverhältnis behandelt werden.
- Strong efficacy with 4.3% mean weight loss and 6.3% maximum at 32 mg dose (p=0.0005)
- Favorable safety profile with no QTcF prolongation and reduced heart rate
- Superior tolerability with mild and infrequent gastrointestinal side effects compared to existing GLP-1 therapies
- No titration required, unlike current obesity treatments
- Demonstrated metabolic benefits with fasting glucose reduction up to 18 mg/dL without hypoglycemia
- Final trial results not yet available - top-line data pending Q4 2025
- Still in early Phase 1 stage of development
- Long-term efficacy and safety data not yet available
Insights
MetaVia's DA-1726 obesity drug shows promising early results with 4.3% mean weight loss and minimal side effects at 32mg; now testing higher 48mg dose.
MetaVia has advanced its Phase 1 clinical trial for DA-1726, a novel dual agonist targeting both GLP-1 and glucagon receptors, by dosing the first patient in the higher 48mg multiple ascending dose cohort. The data from the previous 32mg dose cohort demonstrates significant potential in the competitive obesity treatment landscape.
The 32mg dose achieved
What sets DA-1726 apart is its 3:1 balanced activation ratio between GLP-1 and glucagon receptors, potentially addressing a critical market need. Current GLP-1 therapies suffer from high discontinuation rates (
The addition of this higher dose cohort will help establish the maximum tolerated dose—a crucial parameter for designing future clinical trials. With top-line data expected in Q4 2025, this study could position MetaVia as a significant competitor in the rapidly growing obesity therapeutics market. The promising cardiovascular safety profile, showing no QTcF prolongation and reduced heart rate, further enhances its potential clinical value.
Top-Line Data Expected in the Fourth Quarter of 2025
"The dosing of the first patient in the 48 mg cohort marks the achievement of another key milestone for this promising cardiometabolic asset. To date, clinical data for DA-1726 has demonstrated best-in-class potential, with a favorable safety and tolerability profile, without the need for titration. The addition of a higher dose to the Phase 1 trial will help define the maximum tolerated dose and further unlock the full potential of DA-1726," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "The previously reported data from the 32 mg dose—which we anticipate may serve as the starting dose for future clinical trials—highlight DA-1726's strong therapeutic potential. Specifically, the drug achieved dose-dependent weight loss (mean:
Mr. Kim concluded, "We continue to believe that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors offers a promising alternative to current GLP-1 agonists, addressing significant tolerability challenges that result in discontinuation rates of 20–
The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The study enrolled healthy adults with a minimum body mass index (BMI) between 30 – 45 kg/m2. Nine subjects in each cohort are being randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. 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®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared 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 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 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. DA-1241 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, DA-1241 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, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.
For more information, please visit www.metaviatx.com.
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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FAQ
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