drugset / Trial / NCT07473960
IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tafolecimab | Monoclonal antibody | 150 mg | — |
| Subject | Tafolecimab | Monoclonal antibody | 450 mg | — |