Actively Recruiting
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-04-14
198
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years at consent
- Fasting LDL-C between 2.6 and 4.9 mmol/L at screening and randomization
- Fasting triglycerides at or below 5.64 mmol/L at screening and randomization
- 10-year risk of atherosclerotic cardiovascular disease assessed as low or moderate (< 10%) per 2023 Chinese Guidelines
- Ability to understand study procedures and voluntarily sign informed consent
You will not qualify if you...
- Known allergies to study drugs or severe reactions to antibody drugs
- Prior diagnosis of ASCVD or familial hypercholesterolemia
- History of acute or chronic heart failure (NYHA class III/IV) or left ventricular ejection fraction < 40%
- Severe arrhythmias poorly controlled by medication
- Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
- Severe liver disease, nephrotic syndrome, Cushing's syndrome, or other major lipid-affecting diseases
- Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c ≥ 8.5%, severe hypoglycemia, or multiple daily insulin injections)
- History of cancer within 5 years
- Treatment with PCSK9 antibodies or inclisiran within 6 months
- Participation in other clinical studies within 3 months
- Use of systemic cyclosporine or long-term systemic glucocorticoids within 3 months
- Weight-loss drugs or bariatric surgery within 3 months
- History of drug or alcohol abuse with high alcohol intake
- Abnormal lab values including low eGFR, elevated liver enzymes, high creatine kinase, thyroid dysfunction
- Positive for hepatitis B or C with active infection, HIV, or syphilis
- Female participants of childbearing potential not using contraception as required
- Pregnant or breastfeeding women
- Poor compliance or safety concerns as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100083
Actively Recruiting
Research Team
Y
Yida Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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