The dual agonist is intended to be administered subcutaneously once a week to treat obesity and MASH. Credit: Elena Babanova/Shutterstock.

NeuroBo Pharmaceuticals has concluded subject enrolment in the single ascending dose (SAD) Part 1 portion of its Phase I trial of DA-1726 for obesity treatment.

A new oxyntomodulin (OXM) analogue, DA-1726 is a dual agonist designed to target both glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR). It is intended to be administered subcutaneously once a week to treat obesity and metabolic dysfunction-associated steatohepatitis (MASH).

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In the SAD portion, a total of 45 subjects were enrolled and assigned to one of five groups, with each group receiving either DA-1726 or a placebo in a 6:3 ratio.

This randomised, placebo-controlled, double-blind Phase I trial will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in healthy, otherwise obese individuals.

Part 2 of the trial, which is currently recruiting, is a multiple ascending dose (MAD) study expected to involve approximately 36 participants.

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These subjects will be randomised into four groups in a 6:3 ratio to receive either DA-1726 or a placebo in four weekly doses.

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The first participant in this MAD phase was dosed in June this year.

Evaluating the safety and tolerability of DA-1726 by tracking adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs that lead to discontinuation of treatment is the trial’s primary endpoint.

Secondary endpoints will focus on the pharmacokinetics of DA-1726, measured by serum concentrations over time and metabolite profiling at the highest doses.

In addition, exploratory endpoints will assess DA-1726’s impact on various metabolic, cardiac, and weight-related parameters, including body weight, waist circumference, and body mass index (BMI).

NeuroBo Pharmaceuticals president and CEO Hyung Heon Kim said: “We expect to report top-line data from the SAD Part 1 portion of the Phase I clinical trial in the third quarter of this year, and top-line data from the MAD Part 2 in the first quarter of 2025.

“Further, upon clearance of an updated investigational new drug (IND) application with the US Food and Drug Administration (FDA), we expect to dose the first patient in the planned Part 3 of the trial during the third quarter of 2025, providing an interim data readout in or around mid-2026 and issuing top-line results in the second half of 2026.”