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A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT07230730•Beijing Suncadia Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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≥2.3，and ≤5.6 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

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

January 13, 2026

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2027

Last Updated

February 2, 2026

Enrollment

900

ESTIMATED participants

Conditions

Hyperlipidemia

Interventions

SHR-1918

DRUG

SHR-1918 placebo

DRUG

Contacts

Sheng Qi

CONTACT

+86 0518 82342973 Sheng.qi@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Penn Medicine Healthy Heart

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