A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 Monotherapy in Participants With Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (CREDIT-5)
This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed hyperlipidemia. Approximately 198 participants were planned to be enrolled in the study. The entire study period includes a screening period of no more than 2 weeks, a run-in period of 4 weeks, a double-blind treatment period of 12 weeks, and a safety follow-up period after the last treatment. Participants were required to maintain a stable and healthy lifestyle throughout the trial.
• Male or female, ≥18 and ≤75 years of age on the day of signing informed consent.
• Fasting LDL-C ≥ 2.6 mmol/L and \< 4.9 mmol/L measured in a local laboratory at screening and randomization.
• Fasting triglyceride (TG) ≤ 5.64 mmol/L measured in a local laboratory at screening and randomization.
• According to the 2023 Chinese Guidelines for the Management of Blood Lipids, the 10-year risk of atherosclerotic cardiovascular disease is assessed as low or moderate (\< 10%).
• Understand the study-related procedures and methods, and voluntarily participate in the study and sign the informed consent form.