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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05202509




Registration number
NCT05202509
Ethics application status
Date submitted
22/11/2021
Date registered
21/01/2022
Date last updated
4/06/2024

Titles & IDs
Public title
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
Scientific title
Placebo Controlled, Double Blind, Randomized Cardiovascular Outcome Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With ASCVD Not Adequately Controlled Despite Maximally Tolerated Lipid Modifying Therapies
Secondary ID [1] 0 0
TA-8995-304
Universal Trial Number (UTN)
Trial acronym
PREVAIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Obicetrapib
Treatment: Drugs - Placebo

Experimental: obicetrapib 10mg - one 10mg tablet, once daily.

Placebo comparator: Placebo - one placebo tablet, once daily


Treatment: Drugs: Obicetrapib
10mg obicetrapib tablet

Treatment: Drugs: Placebo
Placebo tablet to resemble obicetrapib
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Cardiovascular Effect (MACE)
Timepoint [1] 0 0
30 months after last participant randomized

Eligibility
Key inclusion criteria
* Males & females = 18 years age.
* Established ASCVD including:
* Coronary artery disease
* Cerebrovascular disease
* Peripheral Artery disease
* On maximally tolerated lipid-modifying therapy
* Fasting LDL-C = 55 mg/dL
* Fasting triglycerides < 400 mg/dL
* Estimated glomerular filtration rate = 30 mL/min
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%
* Have been hospitalized for Heart Failure within 5 years prior to screening
* Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening
* Uncontrolled hypertension
* Diagnosis of homozygous familial hypercholesterolemia (HoFH)
* Active liver disease
* HbA1c =10%
* Thyroid Stimulating Hormone (TSH) > 1.5 times upper limit normal
* Creatine kinase > 3 times upper limit normal
* History of malignancy with surgery in past 3 years
* History of alcohol or drug abuse within past 5 years
* Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine
* Known allergy to study drug
* Participated in previous obicetrapib trial
* Taking gemfibrozil within 30 days screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
Accrual to date
Final
9541
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
Bridge Family Practice - Halls Creek
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment hospital [9] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [10] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [11] 0 0
Western Health - Saint Albans
Recruitment hospital [12] 0 0
Griffith University - Southport
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Wollongong Hospital (Illawarra Shoalhaven Local Health District) - Wollongong
Recruitment hospital [14] 0 0
The Queen Elizabeth Hospital (TQEH) - SA Health - Woodville South
Recruitment hospital [15] 0 0
Dr Heart Pty Ltd at Cholesterol Care Australia - Woolloongabba
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- Adelaide
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5042 - Bedford Park
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- Campbelltown
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4032 - Chermside
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3168 - Clayton
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6210 - Halls Creek
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3084 - Heidelberg
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VIC 3004 - Melbourne
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- Melbourne
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4020 - Redcliffe
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VIC 3021 - Saint Albans
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4222 - Southport
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2500 - Wollongong
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- Woodville South
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4102 - Woolloongabba
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Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NewAmsterdam Pharma
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.
Trial website
https://clinicaltrials.gov/study/NCT05202509
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Ditmarsch, MD
Address 0 0
NewAmsterdam Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05202509