Zhejiang Doer Biologics Completes Enrollment for Phase 1b/2a Trial of DR10624 in Obese Subjects with Hypertriglyceridemia

08 July 2024 | Monday | News


Innovative Tri-Specific Agonist DR10624 Targets FGF21R, GLP-1R, and GCGR; Trial to Assess Safety, Tolerability, and Efficacy in Reducing Body Weight and Improving Lipid Profiles
Image Source : Public Domain

Image Source : Public Domain

Zhejiang Doer Biologics, a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers, today announces that the company has completed the enrollment in the Phase 1b/2a trial evaluating DR10624 in obese subjects with modest hypertriglyceridemia in New Zealand. DR10624 is a first-in-class (FIC), long-acting tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon-like peptide-1 receptor (GLP-1R), and Glucagon receptor (GCGR).

 

The Phase 1b/2a study is a randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of DR10624 in adult obese subjects (BMI of 30 to 45 kg/m2) with modest hypertriglyceridemia (fasting triglyceride ≥150 mg/dL (1.7 mmol/L), and <500 mg/dL (5.7 mmol/L), at screening). The study evaluates DR10624 treatment across four different dose levels. The participants will receive once-weekly subcutaneous injection of DR10624 or placebo (in a 10:2 ratio) for 12 weeks. The study will also evaluate the effects of DR10624 on serum lipids, liver fat, and body weight.

"DR10624 is a novel FIC tri-specific biotherapeutic that specifically agonizing FGF21R, GLP-1R, and GCGR. Utilizing Doer Bio's proprietary MultipleBody® platform technology, DR10624 is designed and engineered to exhibit balanced activity for various metabolic diseases. In our preclinical studies, DR10624 has shown outstanding potency on body weight reduction, blood lipid normalization, and liver function improvement." said Yanshan Huang, Ph.D., founder and Chief Executive Officer of Doer Bio.

"We're excited to announce the successful completion of patient enrollment for our Phase 1b/2a clinical trial of DR10624 in New Zealand. This achievement marks an important milestone in our clinical translation of DR10624 globally. We anticipate reporting the trial results in early 2025. There is a growing unmet medical need for patients suffering from obesity and hypertriglyceridemia. We look forward to developing DR10624 as a potential treatment for patients struggling with metabolic dysfunction." commented Yongliang Fang, Ph.D., Chief Operating Officer of Doer Bio.

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