Phase I Trial for Potential Obesity Treatment Receives IRB Approval
DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR).
NeuroBo Pharmaceuticals announced that it has received first site Institutional Review Board (IRB) approval to proceed with the Phase I clinical trial of DA-1726, according to a press release.1
DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.
In February, FDA cleared its Investigational New Drug (IND) application for DA-1726.2
According to the Centers for Disease Control and Prevention, United States obesity prevalence in adults was 41.9% in 2017 through March 2020. From 1999-2000 through 2017-March 2020, obesity prevalence increased from 30.5% to 41.9%. Obesity-related conditions include heart disease, stroke, and certain types of cancer.3
The Phase I study will be a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The first part will be a single ascending dose (SAD) study, expected to enroll approximately 45 participants. The second part will be a multiple ascending dose (MAD) study, expected to enroll approximately 36 participants, receiving four weekly administrations of DA-1726 or placebo. NeuroBo Pharmaceuticals expects to randomize the first patient in the second quarter of this year.
"With this first site IRB approval, we have achieved another significant milestone in the development of DA-1726, bringing the program one step closer to the clinic," said Hyung Heon Kim, president and CEO of NeuroBo in the press release. "This promising cardiometabolic asset may have a better tolerability profile than currently available GLP-1 agonists due to its balanced activation of GLP1R and glucagon receptors…We look forward to working closely with our contract research organization partner and our investigators, such as Alexander Prezioso, MD, investigator, Clinical Pharmacology of Miami, to start randomizing patients in the second quarter of this year. We expect to report top-line data from the single ascending dose Part 1 in the first half of 2025 and the multiple ascending dose Part 2 in the second half of 2025."
References
- NeuroBo Pharmaceuticals Receives First Site IRB Approval for Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity. News release. February 29, 2024. Accessed March 4, 2024. https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-receives-first-site-irb-approval-for-its-phase-1-clinical-trial-evaluating-da-1726-for-the-treatment-of-obesity-302075572.html
- NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity. News release. February 1, 2024. Accessed March 4, 2024. https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-announces-fda-clearance-of-ind-for-a-phase-1-clinical-trial-of-da-1726-for-the-treatment-of-obesity-302050383.html
- Adult Obesity Facts. Centers for Disease Control and Prevention. May 17, 2022. Accessed March 4, 2024. https://www.cdc.gov/obesity/data/adult.html
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
