The US Food and Drug Administration (FDA) has approved NeuroBo Pharmaceuticals’ investigational new drug (IND) application for DA-1726 to commence a Phase I clinical trial to treat obesity.

A dual oxyntomodulin (OXM) analogue agonist, DA-1726 functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR).

In December, the company filed an IND application with the US FDA to commence this trial of DA-1726 for obesity.

The trial is set to commence in the first half of this year and aims to evaluate the tolerability, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the therapy.

This placebo-controlled, randomised, double-blind study, with a sequential parallel group design, will assess single and multiple ascending doses of DA-1726 in obese, otherwise healthy participants.

Part one, the single ascending dose (SAD) study of the trial, will enrol nearly 45 participants across five cohorts. The part two multiple ascending dose (MAD) study will involve around 36 participants across four cohorts.

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Evaluating the tolerability and safety of DA-1726 by monitoring various adverse events is the trial’s primary goal.

Secondary endpoints will measure the PK profile of DA-1726 through serum concentrations and metabolite profiling at the highest doses.

Additionally, exploratory endpoints will observe DA-1726’s impact on metabolic and cardiac parameters, fasting lipid levels, waist circumference, body weight, and body mass index (BMI).

DA-1726 is designed for once-weekly subcutaneous administration. Its mechanism is associated with weight loss through appetite reduction and higher energy expenditure.

Preclinical studies in mice have shown that DA-1726 attained greater weight loss versus other OXM analogues such as semaglutide and cotadutide.

NeuroBo president and CEO Hyung Heon Kim said: “Clearance of the IND for DA-1726 allows us to proceed with the Phase I programme for this novel GLP-1 and glucagon dual receptor, a potential new treatment to address the significant obesity market.

“Additionally, in mouse models, DA-1726 showed superior weight loss compared to semaglutide (Wegovy), and its administration resulted in similar weight reduction while consuming more food compared to tirzepatide (Mounjaro).

“We look forward to dosing the first patient with DA-1726 during the first half of this year with an expected data readout in the first half of 2025.”