SYH2053 / CSPC Pharma - LARVOL DELTA

Efficacy and safety of SYH2053 in patients with primary hypercholesterolemia or mixed dyslipidemia: a phase II, multicenter, randomized, double-blind, placebo- and active-controlled trial (ESC 2026) - "At screening, they had either received stable-dose statin with or without ezetimibe for ≥ 4 weeks, or no lipid-lowering therapy for ≥ 4 weeks. SYH2053 exhibited rapid, stable and sustained reductions in LDL-C and PCSK9 in primary hypercholesterolemia or mixed dyslipidemia pts. At an equivalent dose of 300 mg, SYH2053 may yield greater reductions in LDL-C and PCSK9 compared with inclisiran. These observations warrant further-validation in future phase III clinical trial."

Clinical • P2 data • Cardiovascular • Dyslipidemia

A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) (clinicaltrials.gov) - P3 | N=135 | Not yet recruiting | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

New P3 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Metabolic Disorders

A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia (clinicaltrials.gov) - P3 | N=760 | Recruiting | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia (clinicaltrials.gov) - P2 | N=156 | Completed | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

New P2 trial • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia (clinicaltrials.gov) - P3 | N=900 | Not yet recruiting | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Monotherapy • New P3 trial • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy (clinicaltrials.gov) - P3 | N=900 | Not yet recruiting | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

New P3 trial • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2053 (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Not yet recruiting ➔ Completed | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion • Trial primary completion date • Dyslipidemia • APOB

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2053 (clinicaltrials.gov) - P1 | N=39 | Not yet recruiting | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

New P1 trial • Dyslipidemia