---
title: A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
nct_id: NCT06305559
overall_status: ACTIVE_NOT_RECRUITING
phase: PHASE3
sponsor: NewAmsterdam Pharma
study_type: INTERVENTIONAL
primary_condition: Lipidemia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06305559.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06305559"
ct_last_update_post_date: 2026-04-09
last_seen_at: "2026-05-12T06:58:23.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

**Official Title:** A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib/Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants With Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT Trial)

**NCT ID:** [NCT06305559](https://clinicaltrials.gov/study/NCT06305559)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** NewAmsterdam Pharma
- **Conditions:** Lipidemia, Coronary Artery Disease, Plaque, Atherosclerotic
- **Start Date:** 2024-05-16
- **Completion Date:** 2028-02
- **CT.gov Last Update:** 2026-04-09

## 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).

## Eligibility

- **Minimum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
```

## Arms

- **Obicetrapib/Ezetimibe** (EXPERIMENTAL) — obicetrapib 10 mg + ezetimibe 10 mg FDC daily
- **Placebo** (PLACEBO_COMPARATOR) — Placebo on top of baseline lipid modifying therapy

## Interventions

- **obicetrapib 10 mg + ezetimibe 10 mg FDC daily** (DRUG) — Active treatment
- **Placebo** (OTHER) — Baseline lipid modifying therapy

## Primary Outcomes

- **• 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.** _(time frame: 18 months)_ — Total plaque comparison measured by CCTA

## Secondary Outcomes

- **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.** _(time frame: 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.** _(time frame: 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** _(time frame: 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.** _(time frame: 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.** _(time frame: 18 Months)_

## Locations (1)

- NGMR, Hialeah, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ngmr|hialeah|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06305559.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06305559*  
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