NCT07521007

A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-controlled Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of YN001 in Adults With Coronary Atherosclerosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Beijing Inno Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.

Detailed description

This is a multinational, multicenter, randomized, parallel, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of intravenously administered YN001 compared with placebo in participants with coronary atherosclerosis who are receiving background therapy for CV risk factors management. A total of 456 participants are expected to be enrolled. The study will consist of a maximum 12-week screening/Baseline period, followed by a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up period through Week 96 (approximately 2 years after randomization).

Conditions

• Atherosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	YN001/Placebo 40mg	Dose 1 YN001/Placebo 40mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
DRUG	YN001/Placebo 20mg	YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
DRUG	YN001/Placebo 0mg	YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-07-31
• Completion: 2029-03-31
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

13 sites across 1 country: China

Regulatory

• FDA-regulated drug study