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

NCT06109831 | Completed Phase 2

• 1 other identifier: SHR-1918-201
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemic

Outcome Measures

Primary Outcomes (1)

• Percent change in calculated LDL-C from baseline to week 16

  from baseline to week 16

Secondary Outcomes (1)

• Change in calculated LDL-C from baseline to week 16

  from baseline to week 16

Study Arms (2)

SHR-1918

EXPERIMENTAL

Drug: SHR-1918

SHR-1918 placebo

PLACEBO COMPARATOR

Drug: SHR-1918 placebo

Interventions

SHR-1918 DRUG

SHR-1918

SHR-1918

SHR-1918 placebo DRUG

SHR-1918 placebo

SHR-1918 placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regularly taking any moderate-intensity or higher dose\* of statin stabilization therapy for ≥4 weeks at screening:
• ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L;
• ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L;
• ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L.
• 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.
• Fasting triglycerides ≤ 5.6 mmol/L.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Xie X, Shi X, Zhang Y, Su S, Jiang C, Miao L, Wang J, Peng D, Lv L, Chai X, Luo S, Zheng Y, Huang S, Zhu D, Liao S, Ren M, Gao X, Yang H, Zhou H, He Y, Han Y, Xu J, Zhang L, Du L, Yao Z, Sheng J, Peng X, Chen X, Li J, Mi J, Lu Q, Wang H, Shen Z, Zhao Z, Gao F, Lv C, Zhu M, Zhu Y, Wang J. Angiopoietin-Like 3 Antibody Therapy in Patients With Suboptimally Controlled Hyperlipidemia: A Phase 2 Study. J Am Coll Cardiol. 2025 May 20;85(19):1821-1835. doi: 10.1016/j.jacc.2025.03.008. Epub 2025 Mar 31.

  PMID: 40167414 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: November 24, 2023
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (1)