456 Participants NeededMy employer runs this trial

YN001 for Coronary Artery Disease

(PURIFY-TIMI 81 Trial)

Recruiting at 39 trial locations
JZ
KZ
Overseen ByKaiqi Zong, Master
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Beijing Inno Medicine Co., Ltd.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, YN001, administered through an IV to individuals with coronary artery disease, where the heart's blood vessels are narrowed. Researchers aim to determine if YN001 is effective and safe for those already taking heart medications. Participants are divided into groups receiving varying doses of the treatment or a placebo. This trial suits individuals with coronary artery issues confirmed by tests and who manage conditions like type 2 diabetes or high blood pressure. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants are receiving background therapy for cardiovascular risk factors, which suggests you may continue your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that YN001 is safe for both healthy individuals and those with coronary artery disease. In earlier studies, most participants tolerated YN001 well, with only a few side effects reported. These studies included both healthy individuals and those with the heart condition targeted in this trial. Participants did not report any major safety issues, and the treatment was well-tolerated at various doses. This suggests that YN001 could be a safe choice for prospective trial participants.12345

Why do researchers think this study treatment might be promising for coronary artery disease?

Unlike the standard treatments for coronary artery disease, which typically include medications like statins, beta-blockers, and ACE inhibitors, YN001 offers a fresh approach. Researchers are excited about YN001 because it is administered intravenously, allowing for potentially faster and more direct delivery to the bloodstream compared to oral medications. Additionally, YN001's novel formulation could target the disease mechanism more precisely, providing a promising alternative for patients who do not respond well to current therapies.

What evidence suggests that YN001 might be an effective treatment for coronary artery disease?

Studies have shown that YN001 can reduce plaque buildup in arteries, a major issue in heart disease. Research indicates a significant decrease in plaque among patients treated with YN001, suggesting the drug might help clear artery blockages. Additionally, animal studies demonstrated YN001's effectiveness and safety, supporting its potential use in humans. Early trials in people found YN001 to be safe with promising results. In this trial, participants will receive different doses of YN001 or a placebo to further evaluate its effectiveness and safety.24678

Who Is on the Research Team?

YC

Ying Chen, PhD

Principal Investigator

Beijing Inno Medicine Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for adults aged 18–80 with diagnosed coronary atherosclerosis, who are already being treated for heart risk factors. Participants may have type 2 diabetes, high blood pressure, reduced kidney function, or be current smokers. Women must not be pregnant or breastfeeding.

Inclusion Criteria

I am between 18 and 80 years old.
I have ASCVD or at least two risk factors like diabetes, age, smoking, high blood pressure, or low kidney function.
I understand the study and have signed the consent form to participate.
See 3 more

Exclusion Criteria

Contraindication for CCTA
I have not had cancer in the past 5 years, except for certain skin cancers.
I have had severe, uncontrolled heart rhythm problems in the last 3 months.
See 26 more

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

12 weeks

Treatment

Participants receive blinded treatment with YN001 or placebo administered intravenously weekly

12 weeks

Safety Follow-up

Participants are monitored for safety after the treatment period

4 weeks

Long-term Follow-up

Participants are monitored for long-term outcomes and adverse events

96 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • YN001

Trial Overview

The study tests different doses of an intravenous drug called YN001 versus placebo in people with coronary artery disease. All participants continue their usual treatments while receiving either YN001 (40mg or 20mg) or a placebo to see if the new drug helps reduce plaque buildup.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 2 YN001/Placebo 20mgExperimental Treatment1 Intervention
Group II: Dose 1 YN001/Placebo 40mgExperimental Treatment1 Intervention
Group III: Dose 3 YN001/Placebo 0mgPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beijing Inno Medicine Co., Ltd.

Lead Sponsor

Trials
3
Recruited
210+

The TIMI Study Group

Collaborator

Trials
22
Recruited
129,000+

Citations

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