Doer Biologics Initiates Phase III Clinical Trial of First-in-Class GLP-1/GCG/FGF21 Tri-Agonist DR10624 for Severe Hypertriglyceridemia

▎Armstrong

On June 10, 2026, Doer Biologics registered the Phase III clinical trial of DR10624 for the treatment of severe hypertriglyceridemia on the Drug Clinical Trial Registration and Information Publicity Platform website.

The primary endpoint of this Phase III clinical trial is the percentage change from baseline in fasting triglycerides (TG) after 26 weeks of treatment.

This Phase III clinical trial plans to enroll 480 subjects, including 340 subjects enrolled in China.

At this year’s EASL conference, Doer Biologics disclosed Phase II clinical data on DR10624 for the treatment of severe hypertriglyceridemia.

After 12 weeks of treatment, all dose groups of DR10624 demonstrated a significant reduction in liver fat content compared to the placebo group, with a maximum median percentage decrease of 67%. The proportions of subjects achieving a relative reduction from baseline in liver fat content (LFC) of ≥30% and ≥50%, as well as those achieving complete normalization of liver fat (LFC <5%), were significantly higher in the DR10624 treatment groups than in the placebo group.

DR10624 can significantly improve ALT, AST, ALP and other indicators closely related to liver function, and achieve statistically significant reductions in some dose groups.

DR10624 improved the degree of liver fibrosis in subjects, with the 50 mg dose group achieving a statistically significant reduction.

A significant increase in adiponectin levels was observed in all DR10624 dose groups after 12 weeks of treatment.

Summary

DR10624 is the world’s first GLP-1/GCG/FGF21 triple-target agonist, demonstrating promising efficacy potential in Phase II clinical trials. The initiation of its pivotal Phase III trial marks entry into the final stage of clinical proof-of-concept (POC), with anticipation for its subsequent clinical progress.