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

Phase 2

Active, not recruiting

• Conditions: Hyperlipidemic
• Interventions: Drug: SHR-1918; Drug: SHR-1918 placebo

• Registration Number: NCT06109831
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-31
• Study Start: 2023-11-24
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-10-30
• Study Completion: 2025-09-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 335

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1918	SHR-1918	-
SHR-1918 placebo	SHR-1918 placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change in calculated LDL-C from baseline to week 16	from baseline to week 16

Secondary Outcome Measures

Name	Time	Method
Change in calculated LDL-C from baseline to week 16	from baseline to week 16

Trial Locations

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China