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

An Efficacy, Safety Study to Evaluate Multiple Subcutaneous SHR-1918 in Combination With Lipid-Lowering Drugs for the Stable Treatment of Hyperlipidemic Patients With Poor Lipid Control-A Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemic
• Intervention / Treatment: Drug: SHR-1918; Drug: SHR-1918 placebo

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chao Lv; Phone Number: +86 13810733217; Email: chao.lv.cl1@hengrui.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Principal Investigator: Jianan Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1918	Drug: SHR-1918; SHR-1918
Placebo Comparator: SHR-1918 placebo	Drug: SHR-1918 placebo; SHR-1918 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in calculated LDL-C from baseline to week 16	from baseline to week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in calculated LDL-C from baseline to week 16	from baseline to week 16

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): September 27, 2025

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1918-201

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