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

September 7, 2026 updated by: Beijing Suncadia Pharmaceuticals Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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/1.73m^2;
  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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The percentage change of serum LDL-C from baseline
Time Frame: Baseline and Week 24
Baseline and Week 24
The percentage change in serum TG from baseline
Time Frame: Baseline and Week 24
Baseline and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
LDL-C goal attainment rates at Week 48, overall and by risk subgroup
Time Frame: Baseline and Week 48
Baseline and Week 48
Percentage change of serum non-high-density lipoprotein cholesterol (non-HDL-C) from baseline
Time Frame: Baseline and Week 24
Baseline and Week 24
The percentage change in serum total cholesterol (TC) from baseline
Time Frame: Baseline and Week 24
Baseline and Week 24
The percentage change of serum apolipoprotein B (ApoB) from baseline at week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
The percentage change of serum apolipoprotein A1 (ApoA1) from baseline
Time Frame: Baseline and Week 24
Baseline and Week 24
The change from baseline in serum LDL-C
Time Frame: Baseline and Week 24
Baseline and Week 24
The change from baseline in serum TG
Time Frame: Baseline and Week 24
Baseline and Week 24
The change from baseline in serum non-HDL-C
Time Frame: Baseline and Week 24
Baseline and Week 24
The change from baseline in serum TC
Time Frame: Baseline and Week 24
Baseline and Week 24
The change from baseline in serum ApoB
Time Frame: Baseline and Week 24
Baseline and Week 24
The change from baseline in serum ApoA1
Time Frame: Baseline and Week 24
Baseline and Week 24
Absolute and relative percent change from baseline in serum lipoprotein(a) (Lp(a))
Time Frame: Baseline and Week 24
Baseline and Week 24
Absolute and relative percent change from baseline in serum high-density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline and Week 24
Baseline and Week 24
LDL-C goal attainment rates at Week 24, overall and by risk subgroup
Time Frame: Baseline and Week 24
Baseline and Week 24
Absolute and percentage change from baseline in serum non-HDL-C at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute and percentage change from baseline in serum ApoB at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute and percentage change from baseline in serum Lp(a) at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute and percentage change from baseline in serum TC at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute and percentage change from baseline in serum TG at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute and percentage change from baseline in serum HDL-C at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute and percentage change from baseline in serum ApoA1 at Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
The incidence and severity of adverse events (AEs) throughout the study
Time Frame: up to week 52
up to week 52
Injection site reactions (pain, pruritus, erythema, swelling, induration, and rash) throughout the study
Time Frame: up to week 52
up to week 52
Major adverse cardiovascular events (Cardiovascular death, Non-fatal myocardial infarction, Non-fatal stroke and Coronary revascularization) throughout the study
Time Frame: up to week 52
up to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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