Clinical Trial

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-15
critical Recruitment opened 2026-04-15
Trial Details
NCT Number NCT07473960
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Enrollment 198 participants
Start Date 2026-04-01
Primary Completion 2026-09-06 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-14