Study design and participants
TG
Forty-nine Chinese institutions participated in this phase III clinical investigation. This research was carried out at many sites utilizing a randomized, placebo-controlled, double-blind trial design. The research followed the rules and guidelines set out by local and/or national independent ethics committees, as well as the principles outlined in the Helsinki Declaration. Institutional review boards authorized the protocol, consent forms, and other pertinent documentation. Before the trial began, all the patients signed informed consent forms. CTR20170362 was the registration number for this study.Eligible participants were men and women over the age of 18 whose TG levels fell between 5.6–22.6 mmol/L (with a stable diet and physical activity). If statin medication (with or without ezetimibe) was used, the dosage must have been stable for at least four weeks before the TG qualifying visit (visit 3 [week 2]).Participants were required to safely stop taking any medications before the screening visit and throughout the course of the study, including niacin doses greater than 200 mg daily, fish oil or other foods rich in omega-3 fatty acids, fibrates, and any herbal or food additives that may regulate lipid levels.