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

NCT06555640 | Completed Phase 2

• 1 other identifier: DR10624-201
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 35

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).

Conditions

Severe Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change of lipid profile and lipoprotein profile

  From baseline to Week 12

• Number of participants whose fasting TG lowered by at least 50%

  From baseline to Week 12

• Change of glycosylated hemoglobin (HbA1C)

  From baseline to Week 12

• Change of liver fat content

  From baseline to week 12

• Change of liver stiffness measurements (LSM)

  From baseline to week 12

Study Arms (6)

Cohort 1: DR10624 injection

EXPERIMENTAL

DR10624 injection administered weekly (QW)

Drug: DR10624 Injection

Cohort 1: Placebo

PLACEBO COMPARATOR

Placebo administered weekly (QW)

Drug: Placebo

Cohort 2: DR10624 injection

EXPERIMENTAL

DR10624 injection administered weekly (QW)

Drug: DR10624 Injection

Cohort 2: Placebo

PLACEBO COMPARATOR

Placebo administered weekly (QW)

Drug: Placebo

Cohort 3: DR10624 injection

EXPERIMENTAL

DR10624 injection administered weekly (QW)

Drug: DR10624 Injection

Cohort 3: Placebo

PLACEBO COMPARATOR

Placebo administered weekly (QW)

Drug: Placebo

Interventions

DR10624 Injection DRUG

Drug: DR10624 injection

Cohort 1: DR10624 injection; Cohort 2: DR10624 injection; Cohort 3: DR10624 injection

Placebo DRUG

Drug: placebo

Cohort 1: Placebo; Cohort 2: Placebo; Cohort 3: Placebo

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female, age of 18 to 75 years (inclusive) at screening.
• Subjects must have a BMI of \>19 kg/m2 and BMI of ≤45.0 kg/m2 , and body weight ≥50 Kg at screening.
• 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).
• 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.
• Subjects will able to accept rencommendation on therapeutic lifestyle modificationa and maintain a stable lifestyle for the duration of the study.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Subjects with type 1 diabetes, or nephrotic syndrome.
• Subjects with cirrhosis, alcoholic liver disease, liver failure, liver cancer, or autoimmune hepatitis.
• Subjects type 2 diabetes with a duration of less than 12 weeks or with severe complications.
• Uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg under medication conditions.
• 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.
• 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.
• 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.
• New York Heart Association Functional Classification III or IV CHF.
• In the opinion of the investigator, the subjects are likely to require concurrent treatment with systemic glucocorticoids during the trial due to comorbidities.
• 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).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (35)

Baoding No.1 Central Hospital

Baoding, China

Location

The First Affiliated Hospital of Baotou Medical College

Baotou, China

Location

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Location

The First Hospital of Jilin University

Changchun, China

Location

The Second Hospital of Jilin University

Changchun, China

Location

Second Xiangya Hospital of Central South University

Changsha, China

Location

Chifeng Municipal Hospital

Chifeng, China

Location

Daqing People's Hospital

Daqing, China

Location

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, China

Location

The Fourth Hospital of Harbin Medical University

Harbin, China

Location

The First Affiliated Hospital of South China University

Hengyang, China

Location

Inner Mongolia People's Hospital.

Hohhot, China

Location

Huzhou Central Hospital

Huzhou, China

Location

Lishui Municipal Central Hospital

Lishui, China

Location

Luoyang Third Peoples Hospital

Luoyang, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Location

Meihekou Central Hospital

Meihekou, China

Location

The Second Affiliated Hospital to Nanchang University

Nanchang, China

Location

The Third Hospital of Nanchang

Nanchang, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

The Affiliated Hospital of Nantong University

Nantong, China

Location

Nanyang Central Hospital

Nanyang, China

Location

Panjin Liaoyou Baoshihua Hospital

Panjin, China

Location

Pingxiang People's Hospital

Pingxiang, China

Location

The People's Hospital of Liaoning Province

Shenyang, China

Location

Shaanxi Provincial People's Hospital

Xi'an, China

Location

The Third Affiliated Hospital of Xinjiang Medical University

Xinxiang, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Location

Yancheng First People's Hospital

Yancheng, China

Location

Yixing People's Hospital

Yixing, China

Location

Yiyang Central Hospital

Yiyang, China

Location

Yueyang Central Hospital

Yueyang, China

Location

Yuncheng Central Hospital

Yuncheng, China

Location

Zibo Municipal Hospital

Zibo, China

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jianping Li, M.D.

  Peking University First Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 15, 2024
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 29, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (35)