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

Inclusion Criteria:

• 1.Subjects or their legally acceptable representatives must be able to providewritten informed consent, understand the procedures and methods of the study, andagree to comply with all protocol requirements.

2.Male or female, age of 18 to 75 years (inclusive) at screening.

3.Subjects must have a BMI of >19 kg/m2 and BMI of ≤45.0 kg/m2 , and body weight ≥50Kg at screening.

4.During screening or within 1 week prior to screening, the TG levels should meetthe following criteria: 4.80 mmol/L (425 mg/dL) ≤ fasting TG < 22.60 mmol/L (2000mg/dL).

5.The average fasting TG level of Visit 2 and Visit 3 values must meet: 5.65 mmol/L (500 mg/dL) ≤fasting TG <22.60 mmol/L(2000 mg/dL); or the average fasting TG levelof Visit 3 and Visit 3.1 values must meet the same criteria.

6.Subjects will able to accept rencommendation on therapeutic lifestylemodificationa and maintain a stable lifestyle for the duration of the study.

7.Subjects who are receiving statins, cholesterol-absorption inhibitor (CAI),fibrates, niacin ≥500 mg/day, or prescription omega-3 fish oil must have achieved astable dose for at least 4 weeks before screening.

8.Subjects diagnosed with type 2 diabetes(T2DM) must have a glycosylated hemoglobinlevel at screening of<9.5%(80 mmol/mol）and treated with lifestyle modification or astable doses of antidiabetic medications for at least 8 weeks prior to screening.

Exclusion Criteria:

• 1.Subjects with known familial hyperchylomicronemia (Fredrickson type 1) ,apo c-IIdeficiency,or familial β-lipoprotein dyslipidemia (Fredrickson type 3); or subjectswith a high suspicion of having this three conditions.

2.Subjects who have lost ≥5% of body weight within 3 months prior to screening, orwho lose ≥5% of body weight during screening, or who plan to lose body weight duringthe study.

3.Subjects with type 1 diabetes, or nephrotic syndrome.

4.Subjects with cirrhosis, alcoholic liver disease, liver failure, liver cancer, orautoimmune hepatitis.

5.Subjects type 2 diabetes with a duration of less than 12 weeks or with severecomplications.

6.Uncontrolled hypertension at screening, defined as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100 mmHg under medication conditions.

7.Subjects with an active or untreated malignancy or who have been in remission froma clinically significant malignancy (other than basal or squamous cell skin cancer,in situ carcinomas of the cervix, or in situ prostate cancer) for <5 years prior toscreening.

8.Subjects with a family or personal history of medullary thyroid carcinoma (MTC),multiple endocrine neoplasia syndrome type 2 (MEN2),severe active or unstablemajor depressive disorder (MDD), or other serious mental disorders (such asschizophrenia, bipolar disorder, or other severe mood or anxiety disorders) orsuicidal.

9.Subjects with a known clinically significant gastric emptying abnormality (e.g.severe diabetic gastroparesis), and who have undergone or plan to undergo gastricbypass surgery or gastric banding surgery during the study, or those who chronicallytake drugs that directly affect GI motility.

10.New York Heart Association Functional Classification III or IV CHF.

11.In the opinion of the investigator, the subjects are likely to require concurrenttreatment with systemic glucocorticoids during the trial due to comorbidities.

12.Subjects with a history of acute pancreatitis within 1 year prior to screening,or a history of chronic pancreatitis, or symptomatic of gallbladder disease (e.g.choledocholithiasis, gallbladder multiple stones, unless treated withcholecystectomy).

13.Subjects with any of the following cardiovascular (CV) conditions within 6 monthsprior to screening: acute myocardial infarction, cerebral hemorrhage or cerebralinfarction (except lacunar infarction), or hospitalization due to CHF, unstableangina pectoris or transient ischemic attack, or cardiac surgery such aspercutaneous coronary intervention and coronary artery bypass grafting,or subjectswho have been treated with GLP-1R agonists, or have participated in a clinical studyinvolving GLP-1R and received the study drug within 6 months prior to screening.

14.Subjects who have undergone large-sized surgery,have been treated with GCGR ormultiple target point and agonists containing FGF-21R targets;have been treated withSiRNA type and monoclonal antibody type of PCSK9 inhibitors;or who have participatedin a clinical study related to above all the types of drug within 3 months prior toscreening.

15.Subjects with severe trauma, severe infection who have not recoveredwithin 4weeks prior to screening,who have been treated with DPP-4 inhibitors, or haveparticipated in a clinical study related to DPP-4 inhibitors and received the studyproduct;who have undergone lipid apheresis or plasma exchange treatment within thelast 4 weeks or plan to undergo apheresis or plasma exchange during the studyperiod.

16.Subjects with hyperthyroidism or hypothyroidism who have the stable dose oftherapeutic drugs less than 3 months prior to screening.

17.Subjects with Cushing's syndrome or who have continuously or cumulatively usedsystemic glucocorticoids for more than 14 days within 6 months before screening,Inhaled or topical corticosteroids are permitted.

18.Subjects who do not agree to discontinue medications, supplements, ornutraceuticals that have lipid-altering effects other than those specified in theprotocol.

19.Subjects who are taking insulin or second-generation antipsychotics and cannotstop taking them.

20.Serum calcitonin ≥20 ng/L (pg/mL) in subjects with eGFR≥60 mL/min/1.73 m2 , orserum calcitonin ≥35 ng/L (pg/mL) in subjects with eGFR <60 mL/min/1.73 m2.

21.Alanine aminotransferase>3.0 × upper limit of normal value (ULN) and/or aspartateaminotransferase>3.0 × ULN and/or total bilirubin>1.5 × ULN.

22.Glomerular filtration rate eGFR < 45 mL/min/1.73 m2

23.TSH > upper normal limit or < lower normal limit.

24.Serum amylase or lipase > 2.0 × ULN.

25.Hemoglobin < 110 g/L (males) or < 100 g/L (females).

26.Test positive for Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), orhepatitis C virus (HCV), HBV and HCV determined by antibodies first and, ifpositive, by DNA/ribonucleic acid (RNA).

27.Clinically significant 12-lead electrocardiogram (ECG) abnormalities at the timeof screening.

28.History of drug abuse or excessive alcohol consumption within 3 months prior toscreening.

29.Presence of potential allergies to the study drug, its ingredients, or drugs ofthe same class.

30.Pregnant or lactating women;as well as men and women of childbearing potentialwho are unwilling to prevent pregnancy throughout the study and within the specifiedtime after the study.

31.Blood donation and/or blood loss ≥400 mL, or bone marrow donation within 3 monthsprior to screening.

32.Subjects in which the investigator deems to that there are any other factors mayaffect the efficacy or safety evaluation of this study(including medical,psychological, social, or geographical considerations) .