A Study of SHR-1918 In Participants With Hypertriglyceridemia
ConditionHypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
History of severe allergies/hypersensitivity reactions, or clinically significant allergies/hypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.
Received or are currently receiving treatment with monoclonal antibodies, siRNA-based drugs, or ASO-based drugs targeting the same target prior to screening.
Have a history of pancreatitis prior to screening or randomization.
Acute ischemic ASCVD events within 3 months prior to screening or randomization.
Trial design
Treatments tested in this trial
- SHR-1918/ SHR-1918 placebo
- SHR-1918/ SHR-1918 placebo
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov