NCT07473960

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

Interventions

Type	Name	Description
DRUG	IBI306	IBI306 150 mg Q2W
DRUG	placebo	Placebo Q2W
DRUG	placebo	Placebo Q4W
DRUG	IBI306	IBI306 450 mg Q4W

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-09-06
• Completion: 2027-02-28
• First posted: 2026-03-16
• Last updated: 2026-04-14

Locations

1 site across 1 country: China