IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (NCT07473960) | Clinical Trial Compass
RecruitingPhase 3
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
China198 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Male or female, ā„18 and ā¤75 years of age on the day of signing informed consent.
ā. Fasting LDL-C ā„ 2.6 mmol/L and \< 4.9 mmol/L measured in a local laboratory at screening and randomization.
ā. Fasting triglyceride (TG) ā¤ 5.64 mmol/L measured in a local laboratory at screening and randomization.
ā. 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%).
ā. Understand the study-related procedures and methods, and voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
ā. Known allergies to the study drugs or their components, or severe allergic reactions to other antibody drugs.
ā. Previously diagnosed as ASCVD, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease, etc.
. Confirmed or suspected familial hypercholesterolaemia according to UK Simon Broome criteria.
ā. History of acute or chronic heart failure with New York Heart Association (NYHA) class III or IV, or left ventricular ejection fraction \< 40% within 3 months prior to screening.
ā. Previous diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, or supraventricular tachycardia poorly controlled by medication, etc.
ā. Poorly controlled hypertension, defined as sitting systolic blood pressure (SBP) ā„ 160 mmHg or diastolic blood pressure (DBP) ā„ 100 mmHg at screening or randomization.
ā. Previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, and other diseases that significantly affect blood lipid levels.
ā. History of type 1 diabetes mellitus, or type 2 diabetes mellitus with one of the following: (1) glycosylated hemoglobin (HbA1c) ā„ 8.5% at screening; (2) severe hypoglycemia within 6 months prior to screening; (3) insulin injection ā„ 2 times per day prior to screening.