Metavia Receives IRB Approval for Phase 1 Part 3 Clinical Trial of Obesity Treatment 'DA-1726' for Stepwise Dose Exploration

Dong-A ST's affiliate Metavia announced on March 19 that it has received approval from the Institutional Review Board (IRB) of a U.S. clinical institution for Part 3 of Phase 1 clinical trials. This trial is designed for a stepwise dose exploration of 'DA-1726', a GLP-1 (glucagon-like peptide-1) and glucagon dual agonist currently being developed as an obesity treatment.

Metavia plans to use Part 3 of the Phase 1 trial to assess the dose suitability of DA-1726 for safe administration of high doses through a two-step process: Step 1 (Phase 1 Part 3A) and Step 2 (Phase 1 Part 3B).

This Phase 1 Part 3 clinical trial will be conducted in 40 healthy adults with obesity. The participants will be divided into two cohorts of 20 each, and randomly assigned to receive repeated doses of either DA-1726 or placebo over a 16-week period.

In Phase 1 Part 3A, the study will evaluate a stepwise dose escalation protocol by administering 16 mg for four weeks followed by an increase to 48 mg, which will be maintained for 12 weeks. In Phase 1 Part 3B, 16 mg will be administered for four weeks, then escalated to 32 mg for another four weeks, and finally increased to 64 mg, which will be maintained for eight weeks, thus evaluating a two-step escalation regimen.

Metavia plans to begin dosing the first patients in both Phase 1 Part 3A and 3B in April.

DA-1726 is a new drug candidate in development as an obesity treatment in the oxyntomodulin analogue class. It acts on both GLP-1 and glucagon receptors, resulting in appetite suppression, increased insulin secretion, and elevated basal metabolic rate in the periphery, ultimately promoting weight loss and glycemic control.

In a previous additional Phase 1 trial of DA-1726, Metavia confirmed a mean weight reduction of 9.1% (9.6 kg) after eight weeks of dosing, a 9.8 cm (3.8 inch) decrease in waist circumference, improvement in fasting blood glucose, and reduced liver stiffness.

Hyungheon Kim, CEO of Metavia, stated, "This IRB approval will advance the development of DA-1726 and is expected to further strengthen DA-1726's competitiveness based on the efficacy, safety, and tolerability data confirmed in previous trials. Through this trial, we will accelerate entry into subsequent clinical stages and further solidify our position as a differentiated next-generation GLP-1 and glucagon dual agonist obesity treatment."

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