Drugs / DR10624
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05378893 | Jun 2022 → Oct 2024 | abdominal obesity-metabolic syndrome | Zhejiang Doer Biologics Co., Ltd. | Completed | Met primary |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT07848880 | Oct 2026 → Apr 2028 expected | hypertriglyceridemia | Zhejiang Doer Biologics Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07024212 | Apr 2025 → Jun 2026 overdue | metabolic dysfunction-associated steatotic liver disease | Zhejiang Doer Biologics Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06555640 | Aug 2024 → Jun 2025 | — | Zhejiang Doer Biologics Co., Ltd. | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT07693777 | Aug 2026 → Feb 2029 expected | hypertriglyceridemia | Zhejiang Doer Biologics Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07680829 | Aug 2026 → Jun 2030 expected | — | Zhejiang Doer Biologics Co., Ltd. | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT07050134 Comparator | Jul 2025 → Dec 2026 expected | atherosclerosis, hypertriglyceridemia | Junbo Ge | Enrolling by invitation | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Zhejiang Doer Biologics Co., Ltd. | Regulatory 道尔生物全球首创三靶点激动剂DR10624治疗成人射血分数保留/射血分数轻度降低的心力衰竭适应症中国IND获批 doerbio.com ↗
近日，浙江道尔生物科技有限公司（以下简称“道尔生物”）收到中国国家药品监督管理局（以下简称“中国 NMPA”）通知，由道尔生物申报的DR10624注射液药品临床试验申请已获得中国NMPA批准，可在中国开展临床试验，适应症为治疗成人射血分数保留/射血分数轻度降低的心力衰竭（Heart Failure Preserved Ejection Fraction/ Heart Failure with Reduced Ejection Fraction，HFpEF/ HFrEF）。 |
| 2026-05-28 | Zhejiang Doer Biologics Co., Ltd. | Results EASL 2026 | 道尔生物公布DR10624在重度高甘油三酯血症II期临床研究中对肝脏脂肪及改善肝脏代谢指标的研究结果 doerbio.com ↗
DR10624, a novel FGF21R/GCGR/GLP-1R triple agonist, significantly reduced liver fat and improved hepatic and metabolic biomarkers in a phase 2 study of patients with severe hypertriglyceridemia |
| 2026-02-04 | Zhejiang Doer Biologics Co., Ltd. | Regulatory 道尔生物全球首创三靶点激动剂DR10624高甘油三酯血症中国IND获批 doerbio.com ↗
DR10624注射液临床试验申请已获得批准，可以开展临床试验，适应症为高甘油三酯血症（Hypertriglyceridemia，HTG）。 |
| 2026-01-16 | Zhejiang Doer Biologics Co., Ltd. | Regulatory 道尔生物全球首创三靶点激动剂DR10624代谢相关脂肪性肝病美国IND获批 doerbio.com ↗
近日，浙江道尔生物科技有限公司（以下简称“道尔生物”）收到美国食品药品监督管理局（以下简称“美国 FDA”）通知，由道尔生物申报的DR10624注射液药品临床试验申请已获得美国FDA批准，可在美国开展临床试验，适应症为代谢相关脂肪性肝病（Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD）。 |
| 2026-01-11 | Zhejiang Doer Biologics Co., Ltd. | Regulatory 道尔生物全球首创三靶点激动剂DR10624被CDE纳入突破性治疗品种，治疗重度高甘油三酯血症 doerbio.com ↗ |
| 2025-11-10 | Zhejiang Doer Biologics Co., Ltd. | Results 重磅|降低甘油三酯达75%，减少肝脏脂肪达67%，道尔生物DR10624的2期临床结果在AHA2025闪耀开场 doerbio.com ↗
临床结果显示，DR10624的各剂量组对于降低甘油三酯（TG）的药效都非常显著且可迅速起效。 |
| 2025-10-21 | Zhejiang Doer Biologics Co., Ltd. | Regulatory DR10624重度高甘油三酯血症美国IND获FDA批准 doerbio.com ↗
由道尔生物申报的DR10624注射液药品临床试验申请已获得美国 FDA 批准， 可在美国开展临床试验，适应症为重度高甘油三酯血症（Severe Hypertriglyceridemia，SHTG）。 |
| 2025-09-16 | Zhejiang Doer Biologics Co., Ltd. | Results 《预告|荣登开场报告！》华东医药控股子公司道尔生物DR10624治疗重度高甘油三酯血症2期临床结果入选AHA 2025最新突破性研究并作开场报告 doerbio.com ↗
本次在AHA 2025上公布的针对SHTG的2期临床研究结果证明了DR10624具有极佳的降低甘油三酯、综合调节致炎性血脂谱、和快速深度消除肝脏脂肪的药效，未来有望成为治疗SHTG和多种心血管疾病的创新疗法。 |
| 2025-05-12 | Zhejiang Doer Biologics Co., Ltd. | Results 将肝脏脂肪降低最高达89%，DR10624在新西兰的1b/2a期临床结果惊艳，入选EASL 2025最新突破 doerbio.com ↗
治疗12周后，DR10624的各剂量组（12.5 mg、25 mg、50 mg和75 mg剂量滴定组）的肝脏脂肪含量较基线相对降幅分别为51.9%、77.8%、79.0%和75.8%，显著高于安慰剂组的26.3%（图1）。 |
| 2022-04-08 | Zhejiang Doer Biologics Co., Ltd. | Regulatory 道尔生物全球首创三靶点激动剂DR10624在新西兰获批临床 doerbio.com ↗
近日，道尔生物收到 新西兰 药品和医疗器械安全管理局（Medsafe）与新西兰健康及残疾伦理委员会（HDEC）的最终批准，许可 注射用DR10624在新西兰开展I期临床试验 ，旨在评估DR10624在人体的安全性和耐受性、药代动力学和初步疗效。 |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DR10624 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07024212 ↗ |
| Action | Activate | “balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities” NCT05378893 ↗ |
| Modality | Protein / enzyme biologic | “DR10624 is an Fc fusion protein tri-agonist” NCT05378893 ↗ |
| Route | Subcutaneous | “administered via subcutaneous injection” NCT05378893 ↗ |