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NOT YET RECRUITING
NCT07473960
PHASE3

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 Monotherapy in Participants With Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (CREDIT-5)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

198

Start Date

2026-04-01

Completion Date

2027-02-28

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

IBI306

IBI306 150 mg Q2W

DRUG

placebo

Placebo Q2W

DRUG

placebo

Placebo Q4W

DRUG

IBI306

IBI306 450 mg Q4W

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China