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Recruiting NCT07349615

A Study of SHR-1918 In Participants With Hypertriglyceridemia

Phase III Interventional Hypertriglyceridemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1918/ SHR-1918 placebo, SHR-1918/ SHR-1918 placebo.
Who it may be relevant to
Registry conditions: Hypertriglyceridemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Percentage change in mean serum triglyceride (TG) levels at Week 20 and Week 24 relative to baseline [Time frame: at 20 weeks and 24 weeks of treatment]
Secondary outcome measures (12)
  • Percentage change in non-HDL-C relative to baseline [Time frame: at 24 weeks of treatment]
  • Percentage change in LDL-C relative to baseline [Time frame: at 24 weeks of treatment]
  • Percentage change in TC relative to baseline [Time frame: at 24 weeks of treatment]
  • Percentage change in ApoB relative to baseline [Time frame: at 24 weeks of treatment]
  • Percentage change in ApoA1 relative to baseline [Time frame: at 24 weeks of treatment]
  • Change in TG relative to baseline [Time frame: at 24 weeks of treatment]
  • Change in non-HDL-C relative to baseline [Time frame: at 24 weeks of treatment]
  • Change in LDL-C relative to baseline [Time frame: at 24 weeks of treatment]
  • Change in TC relative to baseline [Time frame: at 24 weeks of treatment]
  • Change in ApoB relative to baseline [Time frame: at 24 weeks of treatment]
  • Change in ApoA1 relative to baseline [Time frame: at 24 weeks of treatment]
  • Change and percentage change in Lp(a) relative to baseline [Time frame: at 24 weeks of treatment]

Eligibility criteria

Inclusion criteria

  • Male and female ≥ 18 years old, who is able and willing to provide a written informed consent.
  • 1.7 ≤ TG ≤ 5.6 mmol/L.
  • LDL-C < 3.4 mmol/L.
  • 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

  • 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.
  • Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
  • Have a history of pancreatitis prior to screening or randomization.
  • Acute ischemic ASCVD events within 3 months prior to screening or randomization.
  • Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.
  • Malignant tumors within 5 years.
  • 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.
  • 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.
  • Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.
  • Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT07349615 · SHR-1918-305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗