Testing Selnoflast against a placebo for atherosclerosis
Official title: A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events
A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Selnoflast in Reducing Vascular Inflammation in Patients With Atherosclerosis at Risk for Major Adverse Cardiac Events
- Phase 2
- 2 groups
- One site, in Hamilton
- Recruiting
Interventions
- Medication
Selnoflast
Selnoflast will be administered as per the schedule specified in the respective arm.
- Medication
Placebo
Placebo will be administered as per the schedule specified in the respective arm.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Cardio Health Clinical Trials
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Confirmed evidence of atherosclerosis
- +Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan
- +Stable treatment of atherosclerosis through the use of SOCStandard of careThe treatment normally given for a condition outside a study.Read more → medications or revascularization
- +QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording
Exclusion
- −Positive test results for hepatitis B (HBV) infection at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Positive hepatitis C virus (HCV) antibody test at screening
- −Positive human immunodeficiency virus (HIV) test at screening
- −Individuals with Class III and IV heart failure
- −Uncontrolled cardiac arrhythmia
- −Uncontrolled hypertension
- −Suspected or known immunocompromised state
- −History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- −Estimated glomerular filtration rate \<50 mL/min/1.73 m² as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation, at the time of screening.
- −Treatment with any live vaccine within 28 days prior to the first dose of study drug until the end of the study
- −Treatment with other non-live vaccines within 14 days prior to the first dose of study drug until the end of the study
- −Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Selnoflast.
Registry label: A: Selnoflast
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 162 people.
The study is currently expected to finish around February 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Week 12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L]) — measured over Baseline up to Week 12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07448038 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SelnoflastDrug
Selnoflast will be administered as per the schedule specified in the respective arm.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo will be administered as per the schedule specified in the respective arm.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Week 12.
The study as a whole is currently expected to finish around 2028-02-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 162 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Hamilton, Ontario, Canada; Bloomfield Hills, Michigan, United States; Farmington Hills, Michigan, United States; Flint, Michigan, United States; Minneapolis, Minnesota, United States; North Massapequa, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.
Other Sites (6)
Profound Research LLC at Cardiology and Vascular Associates - CAVA
Bloomfield Hills, Michigan, United States
Profound Research LLC at Millenium Cardiology
Farmington Hills, Michigan, United States
Ahmed Arif Medical Research Center (AA MRC LLC )
Flint, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, United States
Eastside Research Associates, LLC dba Era Health Research
Redmond, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.