Ildong Pharmaceutical held an investor relations (IR) meeting on Monday to disclose topline data from its phase 1 clinical trial of ID110521156, a new drug candidate targeting metabolic disorders such as obesity and diabetes.
ID110521156 is a GLP-1 receptor agonist (GLP-1 RA) that mimics the action of the GLP-1 hormone in the body. GLP-1 plays a role in insulin synthesis and secretion, blood glucose reduction, regulation of gastrointestinal motility, and appetite suppression.
The phase 1 study was a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and pharmacokinetic profile of ID110521156. It consisted of a single-ascending dose (SAD) study and a multiple-ascending dose (MAD) study, the company said.
The SAD study showed that drug exposure remained above the therapeutic concentration for more than 18 hours (up to 24 hours). It also confirmed characteristics suitable for once-daily oral dosing, including no accumulation in the body with repeated administration and no effect from food intake.
The MAD study confirmed pharmacodynamic efficacy, including weight reduction and blood glucose lowering. Conducted in 36 healthy adults, the trial divided participants into three cohorts—50 mg, 100 mg, and 200 mg. Each subject received daily oral doses for four weeks.
Results showed an average weight loss of 5.5 percent in the 50 mg group, 6.9 percent in the 100 mg group, and 9.9 percent in the 200 mg group, with a maximum reduction of 13.8 percent. The placebo group saw no ≥5 percent weight loss, while rates in the 50 mg, 100 mg, and 200 mg groups were 55.6 percent, 66.7 percent, and 87.5 percent, respectively.
Blood glucose-lowering effects were also confirmed in a dose-dependent manner using the oral glucose tolerance test (OGTT) and continuous glucose monitoring (CGM).
In terms of safety, despite the absence of a dose-titration step for drug adaptation, only mild (Grade 1) gastrointestinal adverse events were observed across cohorts, with no serious adverse events. No treatment-related discontinuations or dropouts occurred.
Liver enzyme levels, including ALT and AST, remained within normal ranges in all subjects, and no cases of drug-induced liver injury (DILI) were reported.
“This clinical study confirmed the competitive edge of ID110521156 as a potential ‘best-in-class’ oral therapy for obesity and diabetes, demonstrating outstanding weight loss efficacy and safety,” said Lee Jae-jun, chief operating officer (COO) of Ildong Pharmaceutical and CEO of Unovia.
“As an orally administered small-molecule compound, ID110521156 offers advantages over injectable peptides in pharmacological profile, manufacturing efficiency, cost-effectiveness, user convenience, and commercialization prospects,” he added.
Ildong plans to advance ID110521156 into global phase 2 trials next year and continue discussions for out-licensing and commercialization partnerships.