Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2025-07-04

Brief Summary

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This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.

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Detailed Description

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Conditions

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Hyperlipidemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1918

Group Type EXPERIMENTAL

SHR-1918

Intervention Type DRUG

SHR-1918

SHR-1918 placebo

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. Regularly taking any moderate-intensity or higher dose\* of statin stabilization therapy for ≥4 weeks at screening:

1. ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L;
2. ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L;
3. ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L.
2. Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose\* statin stabilization therapy for ≥4 weeks;

a) Fasting LDL-C ≥ 2.6 mmol/L.
3. Fasting triglycerides ≤ 5.6 mmol/L.

Exclusion Criteria

1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%).
2. eGFR \<30ml/min/1.73m2 at the screening visit.
3. CK \>5times ULN at the screening visit.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No