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).
The subjects will be randomly assigned to experimental groups and placebo-controlled groups. Each participant will be enrolled in only one cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
Drug: DR10624 injection
Drug: placebo
Change of fasting TG
The percentage change of fasting TG in all the participants from baseline to Week 12
Time frame: From baseline to Week 12
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)
Time frame: 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
Time frame: From baseline to Week 12
Change of glycosylated hemoglobin (HbA1C)
The change of glycosylated hemoglobin (HbA1C) in all participants
Time frame: From baseline to Week 12
Change of liver fat content
Measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)
Time frame: 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
Time frame: From baseline to week 12
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Baoding No.1 Central Hospital
Baoding, China
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Peking University First Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
The First Hospital of Jilin University
Changchun, China
The Second Hospital of Jilin University
Changchun, China
Second Xiangya Hospital of Central South University
Changsha, China
Chifeng Municipal Hospital
Chifeng, China
Daqing People's Hospital
Daqing, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
...and 25 more locations
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
Time frame: 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.
Time frame: through study completion, up to 17 weeks
Anti-drug antibody(ADA)
Anti-drug antibody(ADA)
Time frame: through study completion, up to 17 weeks
Pharmacokinetic Ctrough blood concentration of DR10624
Pharmacokinetic Ctrough blood concentration of DR10624
Time frame: through study completion, up to 17 weeks