LipidemiaPhase 3REMBRANDTNCT06305559
A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
A Phase 3 study testing obicetrapib 10 mg + ezetimibe 10 mg FDC daily in people with Lipidemia and Coronary Artery Disease, run by NewAmsterdam Pharma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Lipidemia, Coronary Artery Disease, Plaque, Atherosclerotic
- What is being tested?
- obicetrapib 10 mg + ezetimibe 10 mg FDC daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2024to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
- Conditions
- Lipidemia, Coronary Artery Disease, Plaque, Atherosclerotic
- Being tested
- obicetrapib 10 mg + ezetimibe 10 mg FDC daily, Placebo
- Medical subject headings
- Hyperlipidemias, Coronary Artery Disease, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obicetrapib 10 mg + ezetimibe 10 mg FDC dailyDrug
Also called FDC
Active treatment
PlaceboOther
Baseline lipid modifying therapy
| Study group | Role | What they receive |
|---|---|---|
| Obicetrapib/Ezetimibe | Experimental | obicetrapib 10 mg + ezetimibe 10 mg FDC daily Receives: Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily |
| Placebo | Placebo comparator | Placebo on top of baseline lipid modifying therapy Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 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.
Total change in NCPV as measured by CCTA
Measured: 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.
Change in LDL-C levels measured by central lab
Measured: 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
Percent change in plaque volume in most diseased coronary arteries measured by CCTA
Measured: 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.
Absolute change in plaque volume in most diseased coronary arteries measured by CCTA
Measured: 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.
Changes in coronary arterial fat composition measured by CCTA
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start16 May 2024
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305559
- Sponsor's protocol ID
- OBEZ-302
- Acronym
- REMBRANDT
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40683616
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06305559
- Acronym / sponsor ID
- REMBRANDT / OBEZ-302
- Conditions
- Lipidemia, Coronary Artery Disease, Plaque, Atherosclerotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Study start
- 16 May 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obicetrapib/Ezetimibe | Experimental | Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC dailyobicetrapib 10 mg + ezetimibe 10 mg FDC daily |
| Placebo | Placebo comparator | Other: PlaceboPlacebo on top of baseline lipid modifying therapy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| obicetrapib 10 mg + ezetimibe 10 mg FDC dailyAlso: FDCActive treatment | Drug | Obicetrapib/Ezetimibe |
| PlaceboBaseline lipid modifying therapy | Other | Placebo |
Primary outcome
• 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
5 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 40683616McCarthy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing obicetrapib 10 mg + ezetimibe 10 mg FDC daily in people with Lipidemia and Coronary Artery Disease, run by NewAmsterdam Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.