CAMBRIDGE, Mass. - NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a biotech firm specializing in cardiometabolic disease therapies, has announced the receipt of first site Institutional Review Board (IRB) approval for its Phase 1 clinical trial of DA-1726, a novel obesity treatment. The company plans to begin patient randomization in the trial's second quarter.
The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726 in obese but otherwise healthy subjects. The trial will be conducted in two parts, with the first involving single ascending doses and the second multiple ascending doses. NeuroBo anticipates enrolling approximately 45 participants for the first part and 36 for the second, with a 6:3 randomization ratio of DA-1726 to placebo.
DA-1726 is a dual agonist of glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), which has shown potential for weight loss by reducing appetite and increasing energy expenditure. In mouse models, DA-1726 demonstrated improved weight loss compared to existing treatments.
Hyung Heon Kim, President and CEO of NeuroBo, stated the IRB approval marks a significant milestone for the company. He highlighted the asset's potential for better tolerability and its promising preclinical results. Top-line data from the trial's first part is expected in the first half of 2025, with data from the second part anticipated in the latter half of the year.
The primary endpoint of the trial will monitor adverse events to assess the safety and tolerability of DA-1726. Secondary and exploratory endpoints will examine the drug's impact on various metabolic and cardiac parameters.
This article is based on a press release statement from NeuroBo Pharmaceuticals.
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