CompletedPhase 2

Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia

China44 participantsStarted 2024-07-02

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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;
✓. Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the relevant conditions;
✓. TG≤5.6mmol/L.

Exclusion criteria

✕. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;
✕. 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);
✕. Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
✕. Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);
✕. 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).

What they're measuring

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

Timeframe: from baseline to week 24

Trial details

NCT IDNCT06471218

SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-16

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