HRS-1301 / Jiangsu Hengrui Pharma - LARVOL DELTA

Safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301, an oral PCSK9 inhibitor, in healthy participants: a first-in-human, randomized, double-blind, placebo-controlled phaseⅠtrial (ESC 2026) - "Notably, a continued downward trend was observed in LDL-C lowering for the 100 mg and 200 mg doses after 14-days administration. Similar dose-dependent reductions were observed in total cholesterol, non-high-density lipoprotein cholesterol and apolipoprotein B. Conclusion(s)HRS-1301 was well tolerated and demonstrated favorable PK profiles and dose-dependent reductions in LDL-C, supporting its further clinical development as a potential oral therapy for dyslipidemia."

Clinical • First-in-human • P1 data • PK/PD data • Cardiovascular • Dyslipidemia • APOB

A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia

A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Dyslipidemia

A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Nephrology • Renal Disease

A Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Dyslipidemia

A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Dyslipidemia • Nephrology • Renal Disease