A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and also includes To evaluate the effectiveness of SHR-1918 in reducing other lipid indicators in patients with mixed hyperlipidemia and to assess the safety of SHR-1918 in patients with mixed hyperlipidemia.

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: SHR-1918; Drug: SHR-1918 placebo

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sheng Qi; Phone Number: +86 0518 82342973; Email: Sheng.qi@hengrui.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Principal Investigator: Jianan Wang

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. the age must be at least 18 years old, and both men and women are eligible;
2. the patient was receiving a stable dose of statins at the time of screening,, and the fasting LDL-C met: For individuals with extremely high risk of ASCVD, LDL-C≥1.4 mmol/L; for those with very high risk of ASCVD, LDL-C≥1.8 mmol/L; and for those with medium and high risk of ASCVD, ≥2.6 mol/L;
3. Fasting TG≥ 1.7 mmol/L;
4. Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person；

Exclusion Criteria:

1. poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the time of screening or before randomization；
2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ -glutamyl transferase (GGT) > 3× upper limit of normal (ULN), or total bilirubin > 2×ULN；
3. Thyroid stimulating hormone (TSH) is lower than the lower limit of normal (LLN) or greater than 1.5×ULN；
4. The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2；
5. Previously suffering from diseases that have a significant impact on blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1918 low dose	Drug: SHR-1918; SHR-1918
Placebo Comparator: SHR-1918 placebo low dose	Drug: SHR-1918 placebo; SHR-1918 placebo
Experimental: SHR-1918 high dose	Drug: SHR-1918; SHR-1918
Placebo Comparator: SHR-1918 placebo high dose	Drug: SHR-1918 placebo; SHR-1918 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage change of serum LDL-C from baseline;	Baseline and Week 24
The percentage change in serum TG from baseline;	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline;	Baseline and Week 24
The percentage change in serum total cholesterol (TC) from baseline;	Baseline and Week 24
The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24;	Baseline and Week 24
The percentage change of serum apolipoprotein A1 (ApoA1) from baseline;	Baseline and Week 24
The change from baseline in serum LDL-C；	Baseline and Week 24
The change from baseline in serum TG；	Baseline and Week 24
The change from baseline in serum non-HDL-C；	Baseline and Week 24
The change from baseline in serum TC；	Baseline and Week 24
The change from baseline in serum ApoB；	Baseline and Week 24
The change from baseline in serum ApoA1；	Baseline and Week 24
Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a));	Baseline and Week 24
Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C);	Baseline and Week 24
LDL-C goal attainment rates at Week 24, overall and by risk subgroup;	Baseline and Week 24
Absolute and percentage change from baseline in serum non-HDL-C at Week 48;	Baseline and Week 48
Absolute and percentage change from baseline in serum ApoB at Week 48;	Baseline and Week 48
Absolute and percentage change from baseline in serum Lp(a) at Week 48;	Baseline and Week 48
Absolute and percentage change from baseline in serum TC at Week 48;	Baseline and Week 48
Absolute and percentage change from baseline in serum TG at Week 48;	Baseline and Week 48
Absolute and percentage change from baseline in serum HDL-C at Week 48;	Baseline and Week 48
Absolute and percentage change from baseline in serum ApoA1 at Week 48;	Baseline and Week 48
LDL-C goal attainment rates at Week 48, overall and by risk subgroup	Baseline and Week 48
The incidence and severity of adverse events (AEs) throughout the study;	up to week 52
Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study;	up to week 52
Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study;	up to week 52

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias
• Other Study ID Numbers: SHR-1918-302

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