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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-13

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1918 low dose

Group Type EXPERIMENTAL

SHR-1918

Intervention Type DRUG

SHR-1918

SHR-1918 placebo low dose

Group Type PLACEBO_COMPARATOR

SHR-1918 placebo

Intervention Type DRUG

SHR-1918 placebo

SHR-1918 high dose

Group Type EXPERIMENTAL

SHR-1918

Intervention Type DRUG

SHR-1918

SHR-1918 placebo high dose

Group Type PLACEBO_COMPARATOR

SHR-1918 placebo

Intervention Type DRUG

SHR-1918 placebo

Interventions

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SHR-1918

Intervention Type DRUG

SHR-1918 placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No