A Study of SHR-1918 In Participants With Hypertriglyceridemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: SHR-1918/ SHR-1918 placebo; Drug: SHR-1918/ SHR-1918 placebo

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Miaomiao Shi; Phone Number: 18036617171; Email: Miaomiao.shi@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Zhongshan Hospital
      • Principal Investigator: Junbo Ge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；	Drug: SHR-1918/ SHR-1918 placebo; SHR-1918/ SHR-1918 placebo Dose 1; Drug: SHR-1918/ SHR-1918 placebo; SHR-1918/ SHR-1918 placebo Dose 2
Experimental: SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection；	Drug: SHR-1918/ SHR-1918 placebo; SHR-1918/ SHR-1918 placebo Dose 1; Drug: SHR-1918/ SHR-1918 placebo; SHR-1918/ SHR-1918 placebo Dose 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline	at 20 weeks and 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change in non-HDL-C relative to baseline	at 24 weeks of treatment
Percentage change in LDL-C relative to baseline；	at 24 weeks of treatment
Percentage change in TC relative to baseline；	at 24 weeks of treatment；
Percentage change in ApoB relative to baseline；	at 24 weeks of treatment；
Percentage change in ApoA1 relative to baseline；	at 24 weeks of treatment；
Change in TG relative to baseline；	at 24 weeks of treatment；
Change in non-HDL-C relative to baseline；	at 24 weeks of treatment；
Change in LDL-C relative to baseline；	at 24 weeks of treatment；
Change in TC relative to baseline；	at 24 weeks of treatment
Change in ApoB relative to baseline；	at 24 weeks of treatment；
Change in ApoA1 relative to baseline；	at 24 weeks of treatment；
Change and percentage change in Lp(a) relative to baseline；	at 24 weeks of treatment；
Change and percentage change in HDL-C relative to baseline；	at 24 weeks of treatment；
Proportion of subjects with TG < 1.7 mmol/L；	at 24 weeks and 48 weeks of treatment；
Change and percentage change in non-HDL-C relative to baseline；	at 48 weeks of treatment；
Change and percentage change in LDL-C relative to baseline；	at 48 weeks of treatment；
Change and percentage change in TC relative to baseline；	at 48 weeks of treatment；
Change and percentage change in ApoB relative to baseline；	at 48 weeks of treatment；
Change and percentage change in ApoA1 relative to baseline；	at 48 weeks of treatment
Change and percentage change in Lp(a) relative to baseline；	at 48 weeks of treatment；
Change and percentage change in HDL-C relative to baseline；	at 48 weeks of treatment；
Change and percentage change in TG relative to baseline；	at 48 weeks of treatment；
Proportion of subjects who received rescue treatment；	Approximately a year；
Incidence and severity of adverse events and injection site reactions	Approximately a year

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertriglyceridemia
• Other Study ID Numbers: SHR-1918-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No