Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

Beijing Suncadia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: SHR-1918; SHR-1918 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06471218

SHR-1918-203

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 relevant conditions;
3. TG≤5.6mmol/L.

Exclusion criteria

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. 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 ≥ 200 IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200 IU/ml, HBV-DNA ≥ the lower limit of the detection value);
3. Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
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. 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Treatment A:SHR-1918/SHR-1918 Placebo

Experimental group

Treatment:

Drug: SHR-1918; SHR-1918 Placebo

Treatment B:SHR-1918/SHR-1918 Placebo

Experimental group

Treatment:

Drug: SHR-1918; SHR-1918 Placebo