drugset / Trial / NCT07473960

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

NCT07473960

Phase 3 Recruiting 198 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-04-01
Primary completion
2026-09-06
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Tafolecimab Monoclonal antibody 150 mg
Subject Tafolecimab Monoclonal antibody 450 mg

Indications