NCT06305559

Brief Summary

This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
21mo left

Started May 2024

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
May 2024Feb 2028

First Submitted

Initial submission to the registry

February 28, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 16, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

February 28, 2024

Last Update Submit

April 6, 2026

Conditions

LipidemiaCoronary Artery DiseasePlaque, Atherosclerotic

Outcome Measures

Primary Outcomes (1)

  • • To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months.

    Total plaque comparison measured by CCTA

    18 months

Secondary Outcomes (5)

  • Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.

    18 Months

  • Percent change from baseline to 18 months in LDL-C in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared to placebo.

    18 Months

  • Percent change from baseline to 18 months in non-calcified coronary atherosclerotic plaque volume in the most diseased coronary segment (NCPVMD), as measured by CCTA, in participants treated with FDC therapy vs placebo

    18 Months

  • Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.

    18 Months

  • Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo.

    18 Months

Study Arms (2)

Obicetrapib/Ezetimibe

EXPERIMENTAL

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Placebo

PLACEBO COMPARATOR

Placebo on top of baseline lipid modifying therapy

Other: Placebo

Interventions

PlaceboOTHER

Baseline lipid modifying therapy

Placebo
obicetrapib 10 mg + ezetimibe 10 mg FDC dailyDRUG

Active treatment

Also known as: FDC
Obicetrapib/Ezetimibe

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting serum LDL-C ≥70 mg/dL (≥1.81 mmol/L)
  • Evaluable non-calcified plaque of at least 75 mm3 in the major epicardial coronary arteries
  • BMI 18-40, inclusive
  • Max tolerated lipid modifying therapy
  • Estimated glomerular filtration rate ≥40 mL/min/1.73 m2

You may not qualify if:

  • HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
  • Contraindications for CCTA
  • History of coronary artery bypass graft
  • Active liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NGMR

Hialeah, Florida, 33016, United States

Location

Related Publications (1)

  • McCarthy CP, Ballantyne CM, Blankstein R, Budoff MJ, Ditmarsch M, Gibson CM, Kastelein JJP, Navar AM, Nicholls SJ, Ray KK, Shirodaria C, Williams MC, Januzzi JL Jr. Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics. Am Heart J. 2025 Dec;290:325-338. doi: 10.1016/j.ahj.2025.07.012. Epub 2025 Jul 17.

    PMID: 40683616DERIVED

MeSH Terms

Conditions

HyperlipidemiasCoronary Artery DiseasePlaque, Atherosclerotic

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind set-up; post randomization LDL values are not provided to sites (alert triggers are programmed for urgent follow-up)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 12, 2024

Study Start

May 16, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(1)