Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507795-51-00

Acronym

TA-8995-304

Enrollment

4094

Registered

2023-10-05

Start date

2022-05-17

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerotic heart and blood vessel disease (the narrowing of arteries from buildup of plague

Brief summary

the time from Randomization to the first confirmed occurrence of any component of the composite endpoint, including the following: - CV death; - Non-fatal MI; - Non-fatal stroke; or - Non-elective coronary revascularization.

Detailed description

The time from Randomization until the first confirmed occurrence of a composite of CV death, non-fatal MI, or non-fatal stroke, The time from Randomization until the first confirmed occurrence of a composite of all-cause mortality, non-fatal MI, non-fatal stroke, or nonelective coronary revascularization, A total event analysis, defined as the number of CV death events, and first and subsequent/recurrent events of non-fatal MIs, non-fatal strokes, and non-elective coronary revascularization from Randomization until the EOS Visit, The time from Randomization until the first confirmed occurrence of non-fatal MI, The time from Randomization until the first confirmed occurrence of non-elective coronary revascularization

Interventions

DRUGObicetrapib

DRUGThe pharmaceutical form of the placebo drug product is a 6 mm diameter

DRUGwhite

DRUGfilm-coated

DRUGround

DRUGbiconvex tablet with no identifying markings

DRUGmatching the appearance of obicetrapib 5 mg and 10 mg tablets. the placebo to match obcietrapib tablets contain the same qualitative excipient blend as used in the corresponding active tablets but with additional microcrystalline cellulose replacing the obicetrapib drug substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
the time from Randomization to the first confirmed occurrence of any component of the composite endpoint, including the following: - CV death; - Non-fatal MI; - Non-fatal stroke; or - Non-elective coronary revascularization.	—

Secondary

Measure	Time frame
The time from Randomization until the first confirmed occurrence of a composite of CV death, non-fatal MI, or non-fatal stroke, The time from Randomization until the first confirmed occurrence of a composite of all-cause mortality, non-fatal MI, non-fatal stroke, or nonelective coronary revascularization, A total event analysis, defined as the number of CV death events, and first and subsequent/recurrent events of non-fatal MIs, non-fatal strokes, and non-elective coronary revascularization from Randomization until the EOS Visit, The time from Randomization until the first confirmed occurrence of non-fatal MI, The time from Randomization until the first confirmed occurrence of non-elective coronary revascularization	—

Measure

Time frame

—

Countries

Bulgaria, Croatia, Czechia, Denmark, Finland, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026