Zhejiang Doer Biologics Co., Ltd. has announced the dosing of the first patient in its Phase 2 clinical trial evaluating DR10624 for the treatment of severe hypertriglyceridemia (SHTG). DR10624 is a first-in-class, tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon-like peptide-1 receptor (GLP-1R), and Glucagon receptor (GCGR).
The Phase 2 study is designed as a randomized, placebo-controlled, double-blind trial to assess the efficacy and safety of three dose levels of DR10624 in adult patients with SHTG. To be eligible, patients must have mean fasting triglyceride levels of ≥ 5.65 mmol/L (500 mg/dL) at screening. The trial aims to enroll a total of 72 participants.
Novel Tri-agonist Mechanism
DR10624, developed using Doer Bio's proprietary MultipleBody® platform technology, is engineered to exhibit balanced activity across its three targets for the treatment of metabolic diseases. Preclinical studies have demonstrated that DR10624 has significant potency in reducing body weight, lowering triglycerides, normalizing blood lipids, and improving liver function.
Addressing Unmet Needs in SHTG
"We're excited to announce the dosing of first patient in our Phase 2 study of DR10624 for the treatment of severe hypertriglyceridemia," said Yongliang Fang, Ph.D., Chief Operating Officer of Doer Bio. He further noted the heightened risk of acute pancreatitis and atherosclerotic cardiovascular disease (ASCVD) in patients with SHTG, particularly those with uncontrolled hypertriglyceridemia. "This Phase 2 study is designed to identify the optimal dose for pivotal Phase 3 clinical trials. We are eager to advance DR10624 as a potential treatment for patients struggling with SHTG".
Trial Design and Objectives
The primary objective of the Phase 2 trial is to evaluate the change from baseline in fasting triglyceride levels after treatment with DR10624 compared to placebo. Secondary endpoints include assessments of safety, tolerability, and other lipid parameters. More information about the Phase 2 clinical trial is available at clinicaltrials.gov (NCT06555640).
