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

Beijing Suncadia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemic

Treatments: Drug: SHR-1918 placebo; Drug: SHR-1918

Study type: Interventional

Funder types: Industry

Identifiers

NCT06109831

SHR-1918-201

Details and patient eligibility

About

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.

Enrollment: 335 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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335 participants in 2 patient groups, including a placebo group

SHR-1918

Experimental group

Treatment:

Drug: SHR-1918

SHR-1918 placebo

Placebo Comparator group

Treatment:

Drug: SHR-1918 placebo