A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of HRS-1301 in Participants With Dyslipidemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of the study is to explore the reasonable dosage of HRS-1301 in participants with dyslipidemia. The efficacy and safety of HRS-1301 will be evaluated after 12-weeks treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male and female ≥ 18 years old, who is able and willing to provide a written informed consent
• BMI ≥ 18.0 kg/m2
• Clinically diagnosed with ASCVD and LDL-C ≥ 1.8 mmol/L OR, if no history of ASCVD, has intermediate to high risk of developing ASCVD and LDL-C ≥ 2.6 mmol/L
• Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and for 2 weeks after the last dose, and agree to use contraceptive methods as specified in the protocol
Locations
Other Locations
China
The 2nd Affiliated Hospital of Harbin
RECRUITING
Harbin
Contact Information
Primary
Miaomiao Shi
Miaomiao.shi@hengrui.com
18036617171
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2026-08
Participants
Target number of participants: 189
Treatments
Experimental: HRS-1301 Group A
Experimental: HRS-1301 Group B
Experimental: HRS-1301 Group C
Experimental: HRS-1301 Group D
Experimental: HRS-1301 Group E
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.