A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypertriglyceridemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypertriglyceridemia. The efficacy and safety of SHR-1918 will be evaluated after 24-weeks and 48-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.
• 1.7 ≤ TG ≤ 5.6 mmol/L.
• LDL-C \< 3.4 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 after the last dose, and agree to use contraceptive methods as specified in the protocol.
Locations
Other Locations
China
Zhongshan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Miaomiao Shi
Miaomiao.shi@hengrui.com
18036617171
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-11
Participants
Target number of participants: 360
Treatments
Experimental: SHR-1918/ SHR-1918 placebo Group A , subcutaneous injection；
Experimental: SHR-1918/ SHR-1918 placebo Group B, subcutaneous injection；
Related Therapeutic Areas
Sponsors
Leads: Beijing Suncadia Pharmaceuticals Co., Ltd