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New treatment option for Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Official title IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
ClinicalTrials.gov ID: NCT07473960
What this study is testing
What is IBI306?
IBI306 is an investigational medicine, being studied as a potential treatment for non-familial hypercholesterolemia and mixed hyperlipidemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Understand the study-related procedures and methods, and voluntarily participate in the study and sign the informed consent form.
You likely can't join if
- 1\. History of any of the following medical or treatment conditions:
- Known allergies to the study drugs or their components, or severe allergic reactions to other antibody drugs.
- Previously diagnosed as ASCVD, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy...
- Confirmed or suspected familial hypercholesterolaemia according to UK Simon Broome criteria.
- History of acute or chronic heart failure with New York Heart Association (NYHA) class III or IV, or left ventricular ejection fraction \< 40% within...
- Previous diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate...
See the full eligibility criteria
- 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.
- 1\. History of any of the following medical or treatment conditions:
- Known allergies to the study drugs or their components, or severe allergic reactions to other antibody drugs.
- Previously diagnosed as ASCVD, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic...
- Confirmed or suspected familial hypercholesterolaemia according to UK Simon Broome criteria.
- 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.
- 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.
- Poorly controlled hypertension, defined as sitting systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at screening or randomization.
- Previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, and other diseases that significantly affect blood lipid levels.
- History of type 1 diabetes mellitus, or type 2 diabetes mellitus with one of the following: (1) glycosylated hemoglobin (HbA1c) ≥ 8.5% at screening; (2) severe hypoglycemia within 6 months prior to screening; (3)...
- History of malignancy within 5 years prior to screening.
- Treatment with a PCSK9 monoclonal antibody within 6 months prior to screening or treatment with inclisiran prior to screening.
- Participation in a clinical study of any medical device or other drug within 3 months prior to screening (except for screening failure), or less than 5 half-lives from the most recent dose of the investigational drug at...
- Treatment with systemic cyclosporine within 3 months prior to screening.
- Long-term continuous (≥ 7 days) or multiple (≥ 3 times) systemic glucocorticoid therapy within 3 months prior to screening (except for topical, intraocular, intranasal, inhaled, or intra-articular injection).
- Treatment with weight-loss drugs or bariatric surgery within 3 months prior to screening.
- History of drug or alcohol abuse prior to screening. Average weekly alcohol intake: more than 21 units for males and more than 14 units for females (1 unit = 360 mL of beer, or 150 mL of red wine, or 45 mL of distilled...
- Estimated glomerular filtration rate ( eGFR) \< 30 mL/min/1.73 m 2 using the MDRD formula.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × upper limit of normal (ULN), or total bilirubin \> 1.5 × ULN.
- Creatine kinase (CK) \> 3 × ULN.
- Hypothyroidism or hyperthyroidism, defined as thyroid-stimulating hormone (TSH) below the lower limit of normal or exceeding 1.5 times the ULN, respectively.
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) and HBV DNA copy number ≥ 1.0 × 10 3 /mL, or positive for hepatitis C antibody ( except for those who have received complete...
- Positive for human immunodeficiency virus (HIV) antibodies or syphilis-specific antibodies. 3\. Female participants of childbearing potential who did not use contraception within 4 weeks prior to screening, or male or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.