Phase 2 Trial of DR10624, a First-in-Class Triple Agonist, Demonstrates Up to 75% Reduction in Triglycerides and 67% Reduction in Liver Fat in Patients with Severe Hypertriglyceridemia, Highlighted in Opening Late-Breaking Presentation at AHA Scientific Sessions 2025
Huadong Medicine
Large Comprehensive Pharmaceutical Product Developer
Doer Biologics
Biological Drug Developer
DR10624-201 Study's Principal Investigator, Professor Li Jianping, Vice President of Peking University First Hospital and Director of the Cardiovascular Disease Research Institute, delivered the opening presentation at the Late-Breaking Science: Groundbreaking Trials in Cardiometabolic Therapeutics session of the conference, unveiling the highly anticipated clinical data from the DR10624-201 study.
Figure 1-3. Professor Li Jianping delivering the opening report at AHA 2025
DR10624-201 is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study conducted in China. The main inclusion criteria are: (1) aged 18 to 75 years, male or female; (2) BMI during the screening period between 19-45 kg/m².2Within the range; (3) Random spatiotemporal fasting triglycerides ≥500 mg/dL (5.65 mmol/L), and <2000 mg/dL (22.6 mmol/L). Qualified subjects were randomly assigned in a 1:1:1 ratio to three dose groups: 12.5 mg, 25 mg, and 50 mg titration. Within each dose group, qualified subjects were administered DR10624 or an equal volume of placebo subcutaneously in a 3:1 ratio. The dosing frequency was once per week for 12 consecutive weeks. The primary efficacy endpoint was the change in fasting triglycerides (TG) from baseline, and secondary endpoints included: changes in liver fat content assessed by MRI-PDFF, lipid profile: such as total cholesterol, non-HDL-C, HDL-C, etc., other important metabolic indicators: such as body weight, glycated hemoglobin (HbA1c), uric acid, adiponectin, etc., as well as safety and tolerability.
Figure 4. Design of the DR10624-201 Study
Clinical results show that the efficacy of DR10624 at all dose levels in reducing triglycerides (TG) is highly significant and can take effect rapidly. In patients with SHTG, a rapid decline in triglyceride levels can be observed after the first administration of DR10624, and subjects maintained low triglyceride levels throughout the 12-week treatment period. At week 12, compared to placebo, all dose groups of DR10624 achieved a significant reduction in triglyceride levels, with the median percentage decrease reaching up to 75%.
Figure 5. Effect of DR10624 on Fasting Triglyceride Levels
Compared with the placebo group, DR10624 showed a significantly higher response rate in SHTG patients. After treatment with DR10624, 89.5% of subjects had their triglyceride levels reduced to below 500 mg/dL (reducing risks such as acute pancreatitis), 19.1% of subjects had their triglyceride levels reduced to below 150 mg/dL (triglyceride levels returned to normal), and 78.5% of subjects had their triglyceride levels decreased by ≥50% from baseline.
Figure 6. Response Rate of DR10624 in SHTG Patients
In addition, DR10624 also demonstrated excellent efficacy in improving the atherogenic lipid profile. Compared with the placebo, all dose groups of DR10624 significantly reduced total cholesterol (Total cholesterol), non-high-density lipoprotein cholesterol (Non-HDL-C), triglyceride-rich lipoprotein cholesterol (TRL-C, also known as Remnant Cholesterol), very low-density lipoprotein cholesterol (VLDL-C), and apolipoprotein C3 (ApoC3). Meanwhile, DR10624 significantly increased the high-density lipoprotein cholesterol (HDL-C), which is beneficial to cardiovascular health.
Figure 7-8. Effect of DR10624 on Lipid Profile
After 12 weeks of treatment, compared with the placebo group, the liver fat content (LFC) in all dose groups of DR10624 significantly decreased, with the median percentage reduction reaching up to 67%. Moreover, the proportion of subjects treated with DR10624 who achieved a relative reduction in LFC from baseline of ≥30%, ≥50%, and complete normalization of liver fat (LFC<5%) was significantly higher than that in the placebo group.
Figure 9. Effect of DR10624 on Liver Fat
MRI-PDFF imaging data from four representative subjects showed that after 12 weeks of DR10624 treatment, the liver fat in three subjects was almost completely cleared, reaching normalization (LFC<5%), whereas the liver fat content in the placebo-treated subject increased from baseline.
Figure 10. MRI-PDFF images showing changes in liver fat content in representative subjects
More encouragingly, compared to the placebo group, the DR10624 50 mg titration dose group showed a significant increase in adiponectin levels after 12 weeks of treatment (indicating a substantial improvement in insulin sensitivity), a significant reduction in uric acid levels (beneficial for organs such as the kidneys and heart), and weight loss effects. Additionally, in subjects with baseline HbA1c ≥6.5%, DR10624 reduced HbA1c levels by 0.68% (clinically significant). The comprehensive improvement in metabolic indicators observed with DR10624 can be attributed to its unique mechanism of action, specifically its triple receptor agonist activity.
Figure 11. Effect of DR10624 on Metabolic Parameters
DR10624 at all dose levels demonstrated good safety and tolerability in this study. The severity of adverse reactions was mainly mild to moderate. The most common TEAEs included nausea, changes in appetite, and injection site reactions.
Figure 12. Safety and Tolerability of DR10624
The excellent clinical data from the DR10624-201 study indicates that this globally pioneering long-acting triagonist, targeting FGF21R, GCGR, and GLP-1R, has the potential to bring new hope for the treatment of patients with severe hypertriglyceridemia (SHTG)! DR10624 demonstrated significant comprehensive metabolic improvements in SHTG patients: during the 12-week treatment period, it achieved strong and sustained reductions in triglyceride levels (up to 75%), comprehensively optimized atherogenic lipid profiles, rapidly and effectively reduced liver fat (up to 67%), and significantly improved multiple metabolic parameters (adiponectin, uric acid, body weight, HbA1c, etc.). It was well-tolerated with acceptable safety, and the severity of drug-related adverse events was mostly mild to moderate. These positive clinical data support DR10624 in advancing to larger-scale Phase 3 clinical trials in the future, further exploring its therapeutic potential in patient populations with SHTG, mixed hyperlipidemia, and metabolic dysfunction-associated steatohepatitis (MASH).
Figure 13. Summary of the DR10624-201 Study
We would also like to sincerely thank the investigators, researchers, and subjects who participated in the DR10624-201 study!
Figure 14. Group photo from the DR10624-201 investigator meeting
Dr. Junfang Xu, Chief Medical Officer of Huadong Medicine, and Dr. Yongliang Fang, Chief Operating Officer of Doer Biologics, also attended the AHA 2025 conference in New Orleans, USA, together with Professor Jianping Li.
Fig. 15-17. Dr. Junfang Xu and Dr. Yongliang Fang attended the conference and took a group photo with Professor Li's team.
Lvliang
Chairman and General Manager of Huadong Medicine Co., Ltd.
We are highly honored to present the Phase 2 clinical research results of DR10624 for the first time globally in an opening report at AHA 2025, the world's top academic conference in the cardiovascular field. This not only demonstrates the outstanding innovation capabilities of Huadong Medicine and Doer Biologics in the research and development targeting metabolic and cardiovascular diseases but also marks a memorable milestone in the history of China's cardiovascular innovative drug development. Huadong Medicine and Doer Biologics will continue to focus on the R&D of innovative drugs, promoting more China-originated innovative therapies to the world and providing global patients with better treatment options!
Huangyan Mountain
Founder & CEO of Doer Biologics
DR10624 is a first-in-class long-acting triple agonist targeting FGF21R, GCGR, and GLP-1R. DR10624 was developed using Doer Biologics' proprietary MultipleBody® platform technology, aiming to provide comprehensive metabolic benefits to patients with metabolic diseases. The successful release of the positive Phase 2 clinical study results of DR10624 at AHA 2025 on an international stage not only amplifies a strong 'Chinese voice' globally but also strengthens our confidence in Doer Biologics' platform technology.
Fang Yongliang
Chief Operating Officer of Doer Biologics
The public health threat posed by SHTG is receiving increasing attention. Patients with SHTG face a higher risk of acute pancreatitis, fatty liver, and atherosclerotic cardiovascular disease (ASCVD), which in turn increase the risks of hospitalization and mortality. The Phase 2 clinical study results of SHTG, unveiled for the first time at AHA 2025, demonstrate that DR10624 exhibits statistically significant efficacy in reducing triglycerides, comprehensively improving lipid profiles, rapidly and profoundly eliminating liver fat, enhancing insulin sensitivity, and lowering uric acid. The high-dose group also showed clinically meaningful reductions in glycated hemoglobin and body weight, providing subjects with comprehensive metabolic benefits. DR10624 holds promise as an innovative therapy for the treatment of SHTG, fatty liver, and various cardiovascular diseases.
About Doer Biologics
Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics"), a controlled subsidiary of Huadong Medicine Co., Ltd., is a clinical-stage biopharmaceutical company focused on discovering and developing multi-specific biotherapeutics based on multi-domain structures to address unmet medical needs in the fields of metabolic diseases and cancer.
Doer Biologics has developed a variety of proprietary platform technologies, including xLONGylation®, MultipleBody®, AccuBody®, and SMART-VHHBody.
For more information about Doer Biologics, please visit www.doerbio.com or contact bd@doerbio.com.
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