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

NCT ID: NCT06555640

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-08-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1: DR10624 injection

DR10624 injection administered weekly (QW)

Group Type: EXPERIMENTAL

DR10624 Injection

Intervention Type: DRUG

Drug: DR10624 injection

Cohort 1: Placebo

Placebo administered weekly (QW)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Drug: placebo

Cohort 2: DR10624 injection

DR10624 injection administered weekly (QW)

Group Type: EXPERIMENTAL

DR10624 Injection

Intervention Type: DRUG

Drug: DR10624 injection

Cohort 2: Placebo

Placebo administered weekly (QW)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Drug: placebo

Cohort 3: DR10624 injection

DR10624 injection administered weekly (QW)

Group Type: EXPERIMENTAL

DR10624 Injection

Intervention Type: DRUG

Drug: DR10624 injection

Cohort 3: Placebo

Placebo administered weekly (QW)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Drug: placebo

Interventions

DR10624 Injection

Drug: DR10624 injection

Intervention Type: DRUG

Placebo

Drug: placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1.Subjects or their legally acceptable representatives must be able to provide written informed consent, understand the procedures and methods of the study, and agree 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 ≥50 Kg at screening.

4.During screening or within 1 week prior to screening, the TG levels should meet the following criteria: 4.80 mmol/L (425 mg/dL) ≤ fasting TG < 22.60 mmol/L (2000 mg/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 level of Visit 3 and Visit 3.1 values must meet the same criteria.

6.Subjects will able to accept rencommendation on therapeutic lifestyle modificationa 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 a stable dose for at least 4 weeks before screening.

8.Subjects diagnosed with type 2 diabetes(T2DM) must have a glycosylated hemoglobin level at screening of<9.5%(80 mmol/mol）and treated with lifestyle modification or a stable 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-II deficiency,or familial β-lipoprotein dyslipidemia (Fredrickson type 3); or subjects with a high suspicion of having this three conditions.

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

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

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

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

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

7.Subjects with an active or untreated malignancy or who have been in remission from a 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 to screening.

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

9.Subjects with a known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis), and who have undergone or plan to undergo gastric bypass surgery or gastric banding surgery during the study, or those who chronically take 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 concurrent treatment 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 with cholecystectomy).

13.Subjects with any of the following cardiovascular (CV) conditions within 6 months prior to screening: acute myocardial infarction, cerebral hemorrhage or cerebral infarction (except lacunar infarction), or hospitalization due to CHF, unstable angina pectoris or transient ischemic attack, or cardiac surgery such as percutaneous coronary intervention and coronary artery bypass grafting,or subjects who have been treated with GLP-1R agonists, or have participated in a clinical study involving 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 or multiple target point and agonists containing FGF-21R targets;have been treated with SiRNA type and monoclonal antibody type of PCSK9 inhibitors;or who have participated in a clinical study related to above all the types of drug within 3 months prior to screening.

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

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

17.Subjects with Cushing's syndrome or who have continuously or cumulatively used systemic 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, or nutraceuticals that have lipid-altering effects other than those specified in the protocol.

19.Subjects who are taking insulin or second-generation antipsychotics and cannot stop taking them.

20.Serum calcitonin ≥20 ng/L (pg/mL) in subjects with eGFR≥60 mL/min/1.73 m2 , or serum 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 aspartate aminotransferase>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), or hepatitis C virus (HCV), HBV and HCV determined by antibodies first and, if positive, by DNA/ribonucleic acid (RNA).

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

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

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

30.Pregnant or lactating women;as well as men and women of childbearing potential who are unwilling to prevent pregnancy throughout the study and within the specified time after the study.

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

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Doer Biologics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianping Li, M.D.

Role: STUDY_CHAIR

Peking University First Hospital

Locations

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

The Fourth Hospital of Harbin Medical University

Harbin, , China

The First Affiliated Hospital of South China University

Hengyang, , China

Inner Mongolia People's Hospital.

Hohhot, , China

Huzhou Central Hospital

Huzhou, , China

Lishui Municipal Central Hospital

Lishui, , China

Luoyang Third Peoples Hospital

Luoyang, , China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, , China

Meihekou Central Hospital

Meihekou, , China

The Second Affiliated Hospital to Nanchang University

Nanchang, , China

The Third Hospital of Nanchang

Nanchang, , China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, , China

The Affiliated Hospital of Nantong University

Nantong, , China

Nanyang Central Hospital

Nanyang, , China

Panjin Liaoyou Baoshihua Hospital

Panjin, , China

Pingxiang People's Hospital

Pingxiang, , China

The People's Hospital of Liaoning Province

Shenyang, , China

Shaanxi Provincial People's Hospital

Xi'an, , China

The Third Affiliated Hospital of Xinjiang Medical University

Xinxiang, , China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, , China

Yancheng First People's Hospital

Yancheng, , China

Yixing People's Hospital

Yixing, , China

Yiyang Central Hospital

Yiyang, , China

Yueyang Central Hospital

Yueyang, , China

Yuncheng Central Hospital

Yuncheng, , China

Zibo Municipal Hospital

Zibo, , China

Countries

China

Other Identifiers

DR10624-201

Identifier Type: -

Identifier Source: org_study_id