NCT06555640

A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous Injection of DR10624 in Subjects With Severe Hypertriglyceridemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Zhejiang Doer Biologics Co., Ltd. · Industry
• Sex: All
• Age: 17 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. The objectives of the planned clinical investigation will be to evaluate the efficacy of DR10624 on fasting serum triglyceride (TG) levels after 12 weeks of treatment in subjects with severe hypertriglyceridemia (SHTG).

Detailed description

The subjects will be randomly assigned to experimental groups and placebo-controlled groups. Each participant will be enrolled in only one cohort.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	DR10624 Injection	Drug: DR10624 injection
DRUG	Placebo	Drug: placebo

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-06-30
• Completion: 2025-08-29
• First posted: 2024-08-15
• Last updated: 2026-01-13

Locations

35 sites across 1 country: China