Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

February 4, 2026 updated by: Beijing Suncadia Pharmaceuticals Co., Ltd

Evaluation of the Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1918 in Patients With Hyperlipidemia in Poor Control: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials

Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Meizhou, Guangdong, China, 514031
        • Meizhou People's Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;
  2. Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the relevant conditions;
  3. TG≤5.6mmol/L.

Exclusion Criteria:

  1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
  2. Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200 IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ the lower limit of the detection value);
  3. Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
  4. Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
  5. Glomerular filtration rate (eGFR)<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L).

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
Intervention / Treatment
Experimental: Treatment A:SHR-1918/SHR-1918 Placebo
Drug: SHR-1918; SHR-1918 Placebo
SHR-1918/SHR-1918 Placebo,two administration
Experimental: Treatment B:SHR-1918/SHR-1918 Placebo
Drug: SHR-1918; SHR-1918 Placebo
SHR-1918/SHR-1918 Placebo,two administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in calculated LDL-C from baseline to week 24
Time Frame: from baseline to week 24
from baseline to week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in calculated TG from baseline to week 24
Time Frame: from baseline to week 24
from baseline to week 24

Collaborators and Investigators

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

Sponsor

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)

July 2, 2024

Primary Completion (Actual)

May 16, 2025

Study Completion (Actual)

May 16, 2025

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1918-203

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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