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

ConditionsAtherosclerosisCoronary Artery Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Inno Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understands the purposes, features, and methods of the study and the possible adverse reactions, and is voluntarily willing to participate in the study, and signs the informed consent form (ICF) before performing any study-specific assessment.

Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF).

A history of Type 2 diabetes requiring treatment with medication,

Aged > 55 years (women) or > 50 years (men),

Disqualifiers

Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.

Previously received YN001.

Any type of vaccination within 4 weeks prior to randomization, or any planned vaccination during the study treatment period

Contraindication for CCTA

Trial design

Design model

Parallel

Treatments tested in this trial

  • YN001/Placebo 40mg

    Drug

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

  • YN001/Placebo 20mg

    Drug

    YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

  • YN001/Placebo 0mg

    Drug

    YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Treatment groups

456 Participants
are divided into 3 treatment groups
Group A: Dose 1 YN001/Placebo 40mgExperimental treatment 1 intervention
Group B: Dose 2 YN001/Placebo 20mgExperimental treatment 1 intervention
Group C: Dose 3 YN001/Placebo 0mgPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relative change from baseline in coronary NCPV at Week 13

Relative change in coronary NCPV from baseline to Week 13 as determined by coronary computed tomography angiography (CCTA)

Time frame
Baseline to Week 13

Secondary outcomes

1

Absolute change from baseline in carotid intima-media thickness (IMT) at Week 13

Absolute change in carotid IMT from baseline to Week 13 as determined by carotid ultrasound.

Time frame
From baseline to Week 13
2

Absolute change from baseline in carotid intima-media thickness (IMT) at Week 9

Absolute change from baseline in carotid intima-media thickness (IMT) at Week 9

Time frame
From baseline to Week 9
3

Relative change from baseline in carotid intima-media thickness (IMT) at Week 13

Relative change in carotid IMT from baseline to Week 13 as determined by carotid ultrasound

Time frame
From baseline to Week 13
4

Relative change in the maximum thickness and area of carotid plaque at Week 9, and Week 13

Relative change in the maximum thickness and area of carotid plaque from baseline to Week 9, and Week 13 as determined by carotid ultrasound

Time frame
From baseline to Week 9 and Week 13

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Inno Medicine Co., Ltd.

Lead sponsor

The TIMI Study Group

Collaborator

Source ClinicalTrials.gov
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