NeuroBo Pharmaceuticals, Inc. has announced the completion of enrollment for the single ascending dose (SAD) Part 1 of its Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity. This randomized, placebo-controlled, double-blind study aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726 in obese, otherwise healthy subjects. A total of 45 participants were enrolled and randomized into one of five cohorts, with each cohort randomized in a 6:3 ratio of DA-1726 to placebo.
DA-1726: A Novel Dual Agonist
DA-1726 is a novel oxyntomodulin (OXM) analog that functions as a dual agonist of the glucagon-like peptide-1 receptor (GLP1R) and the glucagon receptor (GCGR). This dual action is designed to reduce appetite and increase energy expenditure, potentially leading to superior weight loss compared to selective GLP1R agonists. Pre-clinical data has indicated that DA-1726 resulted in improved weight loss compared to semaglutide (Wegovy) and similar weight reduction while consuming more food compared to tirzepatide (Zepbound).
Clinical Trial Design and Endpoints
The Phase 1 trial is structured to evaluate both single ascending doses (SAD) and multiple ascending doses (MAD) of DA-1726. Part 2 of the trial, which is currently enrolling subjects, is designed as a MAD study and is expected to enroll approximately 36 participants. These participants will be randomized at a 6:3 ratio into four cohorts, each receiving four weekly administrations of DA-1726 or placebo. The primary endpoint of the trial is to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs).
Secondary endpoints include evaluating the PK of DA-1726 via serum concentrations over time and metabolite profiling at the highest doses. Exploratory endpoints will assess the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index (BMI).
Anticipated Timeline and Future Development
NeuroBo anticipates reporting top-line data from the SAD Part 1 portion of the Phase 1 clinical trial in the third quarter of this year and top-line data from the MAD Part 2 in the first quarter of 2025. Furthermore, pending clearance of an updated Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), the company expects to dose the first patient in the planned Part 3 of the trial during the third quarter of 2025, with an interim data readout expected around mid-2026 and top-line results in the second half of 2026.
According to Hyung Heon Kim, President and Chief Executive Officer of NeuroBo, the company encountered no significant issues during the SAD study, allowing them to begin the multiple ascending dose (MAD) study ahead of schedule. Kim also noted that data presented at the American Diabetes Association 84th Scientific Sessions showed that DA-1726 demonstrated superior weight loss compared to survodutide, a drug with the same mechanism of action, while also demonstrating retention of relative lean body mass preservation compared to survodutide while also exhibiting superior glucose lowering.
Potential Impact on Obesity Treatment
If successful, DA-1726 could offer a new treatment option for obesity, a significant and growing global health concern. The dual agonist mechanism aims to provide enhanced weight loss with a potentially improved tolerability profile compared to existing GLP-1 agonists. The ongoing Phase 1 trial is a critical step in evaluating the safety and efficacy of this novel compound.
