Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

Phase 2

Active, not recruiting

• Conditions: Hyperlipidemia
• Interventions: Drug: SHR-1918; SHR-1918 Placebo

• Registration Number: NCT06471218
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Brief Summary

Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-24
• Study Start: 2024-07-02
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;
2. Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the following conditions:
3. TG≤5.6mmol/L；

Exclusion Criteria

1. (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
2. (2) Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200IU/ml, HBV-DNA ≥ the lower limit of the detection value);
3. (3) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
4. (4) Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
5. (5) Glomerular filtration rate (eGFR)<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A:SHR-1918/SHR-1918 Placebo	SHR-1918; SHR-1918 Placebo	-
Treatment B:SHR-1918/SHR-1918 Placebo	SHR-1918; SHR-1918 Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change in calculated LDL-C from baseline to week 24	from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Percent change in calculated TG from baseline to week 24	from baseline to week 24

Trial Locations

Locations (1)

Meizhou People's Hospital; 🇨🇳 Meizhou, Guangdong, China