Doer Biologics Completes Phase 2 Enrollment for Novel Tri-Specific Agonist Targeting Severe Hypertriglyceridemia
核心洞察
Doer Biologics (搜索) has completed enrollment of 79 patients in its Phase 2 clinical trial evaluating DR10624, a first-in-class tri-specific agonist targeting FGF21R, GCGR, and GLP-1R for severe hypertriglyceridemia (搜索).
The randomized, placebo-controlled study will evaluate three dose levels of DR10624 in patients with fasting triglycerides ≥500 mg/dL over a 12-week period, with topline data expected in Q3 2025.
Preclinical and early clinical data suggest DR10624 demonstrates significant potency in reducing triglycerides, normalizing blood lipids, and improving liver function, potentially addressing serious complications like acute pancreatitis (搜索) and ASCVD.
Zhejiang Doer Biologics Co., Ltd. (搜索) (Doer Bio) announced today the completion of patient enrollment in its Phase 2 clinical study evaluating DR10624 for the treatment of severe hypertriglyceridemia (搜索) (SHTG). The trial has successfully enrolled 79 patients with this serious metabolic condition.
DR10624 represents a novel approach to treating SHTG as a first-in-class, tri-specific agonist simultaneously targeting Fibroblast growth factor 21 receptor (搜索) (FGF21R), Glucagon receptor (搜索) (GCGR), and Glucagon-like peptide-1 receptor (搜索) (GLP-1R). This multi-target approach aims to address the complex pathophysiology of severe hypertriglyceridemia (搜索).
Trial Design and Patient Population
The DR10624-201 study is designed as a randomized, placebo-controlled, double-blind clinical trial evaluating the efficacy and safety of three different dose levels of DR10624. The study specifically targets adult patients with severe hypertriglyceridemia (搜索), defined as those having mean fasting triglycerides greater than or equal to 5.65 mmol/L (500 mg/dL) at screening.
The 79 enrolled participants will be monitored over a 12-week treatment period. The primary objective is to determine the optimal dose for advancing DR10624 as a potential new treatment option for SHTG patients.
Mechanism of Action and Development Platform
DR10624 was developed using Doer Bio's proprietary MultipleBody® platform technology, which enables the creation of multi-specific biologics with balanced activity profiles.
"DR10624 is a first-in-class long-acting tri-agonist targeting FGF21R, GCGR, and GLP-1R," explained Yanshan Huang, Ph.D., founder and Chief Executive Officer of Doer Bio. "Developed using Doer Bio's proprietary MultipleBody® platform technology, DR10624 was engineered to exhibit balanced activity for metabolic diseases. In non-clinical and clinical studies, DR10624 has demonstrated extraordinary potency in reducing triglycerides, normalizing blood lipids, and improving liver function."
Clinical Significance and Unmet Need
Severe hypertriglyceridemia (搜索) represents a significant health concern, affecting approximately 1-2% of the global population. Patients with SHTG face substantially increased risks of developing acute pancreatitis (搜索), a potentially life-threatening condition, as well as atherosclerotic cardiovascular disease (搜索) (ASCVD).
Current treatment options for SHTG include dietary modifications, fibrates, omega-3 fatty acids, and niacin. However, many patients fail to achieve adequate triglyceride control with existing therapies, highlighting the need for more effective treatment approaches.
Yongliang Fang, Ph.D., Chief Operating Officer of Doer Bio, emphasized the importance of this development: "There is growing awareness of the public health threat posed by SHTG. Patients with SHTG face an increased risk of developing acute pancreatitis (搜索) and atherosclerotic cardiovascular disease (搜索), conditions that elevate the risk of hospitalization and death."
Timeline and Next Steps
The company expects to report topline data from the Phase 2 trial in the third quarter of 2025. These results will inform the design and implementation of potential future Phase 3 studies, pending positive efficacy and safety outcomes.
The clinical trial is registered on clinicaltrials.gov under the identifier NCT06555640, where additional information about the study design and objectives can be accessed.
About Doer Biologics
Zhejiang Doer Biologics Co., Ltd. (搜索) is a clinical-stage biopharmaceutical company headquartered in Hangzhou, China. The company focuses on the discovery and development of multi-domain based multi-specific biotherapeutics addressing unmet medical needs in metabolic diseases and cancers.
Doer Bio has developed several proprietary platform technologies, including xLONGylation®, MultipleBody®, AccuBody®, and SMART-VHHBody, which enable the creation of novel biologics with multiple mechanisms of action.