A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
NCT Number: NCT06555640
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Severe Hypertriglyceridemia
Interventions: DRUG: DR10624 Injection|DRUG: Placebo
Sponsor: Zhejiang Doer Biologics Co., Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-10-30
Locations: Peking University First Hospital, Beijing, China

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).

Primary Outcome Measures: Change of fasting TG, The percentage change of fasting TG in all the participants from baseline to Week 12, From baseline to Week 12
Secondary Outcome Measures: Change of lipid profile and lipoprotein profile, The percentage change of fasting total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-high density lipoprotein cholesterol (non-HDL-C), very low density lipoprotein cholesterol (VLDL-C), free fatty acid (FFA), triglyceride rich lipoprotein cholesterol (TRL-C), lipoprotein (a) \[Lp(a)\], apolipoprotein C3 (Apo C3), apolipoprotein B (Apo B), apolipoprotein B48 (Apo B48), apolipoprotein B100 (Apo B100), apolipoprotein A1 (Apo A1) and apolipoprotein A5 (Apo A5), From baseline to Week 12|Number of participants whose fasting TG lowered by at least 50%, The number of participants whose fasting TG decreased by at least 50% from baseline, From baseline to Week 12|Change of glycosylated hemoglobin (HbA1C), The change of glycosylated hemoglobin (HbA1C) in all participants, From baseline to Week 12|Change of liver fat content, Measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF), From baseline to week 12|Change of liver stiffness measurements (LSM), The change of liver stiffness in subjects with baseline hepatic fat fraction of at least 8% measured by FibroScan, From baseline to week 12|Change of controlled decay index (CAP), The change of CAP in subjects with baseline hepatic fat fraction of at least 8% measured by MRI-PDFF, From baseline to week 12|Incidence and severity of adverse events, The number of participants with treatment-related adverse events as assessed by CTCAE V5.0, such outcomes are included but not limited to hypoglycemia events, injection site reactions, 12-lead Electrocardiogram (ECG) QTc intervals and vital signs (blood pressure, heart rate, respiratory rate and body temperature), physical examinations and safety laboratory tests, etc., through study completion, up to 17 weeks|Anti-drug antibody（ADA）, Anti-drug antibody（ADA）, through study completion, up to 17 weeks|Pharmacokinetic Ctrough blood concentration of DR10624, Pharmacokinetic Ctrough blood concentration of DR10624, through study completion, up to 17 weeks