A Phase III Study To Evaluate the Efficacy And Safety Of SHR-1918 In Participants With Hypertriglyceridemia

Beijing Suncadia Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: SHR-1918/ SHR-1918 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07349615

SHR-1918-305

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-weeks treatment.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female ≥ 18 years old, who is able and willing to provide a written informed consent
2. 1.7≤TG≤5.6 mmol/L
3. LDL-C <3.4 mmol/L
4. Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol

Exclusion criteria

1. History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures
2. Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening
3. Have a history of pancreatitis prior to screening or randomization
4. Acute ischemic ASCVD events within 3 months prior to screening or randomization
5. Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization
6. Malignant tumors within 5 years
7. Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening
8. Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization
9. Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension
10. Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups

SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；

Experimental group

Treatment:

Drug: SHR-1918/ SHR-1918 placebo

Drug: SHR-1918/ SHR-1918 placebo

SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection；

Experimental group

Treatment:

Drug: SHR-1918/ SHR-1918 placebo

Drug: SHR-1918/ SHR-1918 placebo