Caristo Chosen by Leading Pharma Company as Worldwide Imaging Core Lab to Measure Coronary Plaque and Inflammation

Rhea-AI Summary

Caristo Diagnostics was chosen as the worldwide imaging core lab for NewAmsterdam Pharma (NASDAQ: NAMS) REMBRANDT Cardiovascular Imaging Trial announced Oct 14, 2025. Caristo will oversee all coronary plaque and inflammation measurements and monitoring across the study.

REMbrandT is a placebo-controlled, double-blind, randomized trial recruiting at 50 sites in 7 countries to assess obicetrapib+ezetimibe FDC. The primary endpoint is percent change in total noncalcified coronary atherosclerotic plaque volume (NCPV) at 18 months. Secondary endpoints include percent change in LDL-C and change in Caristo's proprietary FAI-Score for coronary inflammation.

Positive

• Selected as worldwide imaging core lab for REMBRANDT
• 50 sites in 7 countries indicate international trial scale
• Primary endpoint: percent change in NCPV at 18 months
• Secondary endpoint includes Caristo's proprietary FAI-Score

Negative

• Primary efficacy readout occurs at 18 months, implying long timeline for results

Insights

Clinical Imaging Expert

Caristo selected as global imaging core lab for REMBRANDT; will measure plaque and inflammation over 18 months.

Caristo Diagnostics will certify sites, perform baseline and follow-up CCTA analyses at 6 and 18 months, quantify noncalcified coronary atherosclerotic plaque volume (NCPV), and report perivascular fat attenuation index (FAI-ScoreTM) for inflammation.

The trial tests a fixed dose combination of obicetrapib and ezetimibe with a primary endpoint of percent change in total NCPV from baseline to 18 months, and secondary endpoints including absolute NCPV change, percent change in LDL-C, and change in FAI-ScoreTM. Rigorous image quality control, anonymization, and radiation dose optimization are stated responsibilities.

Key dependencies and risks include consistent CCTA acquisition across 50 sites in 7 countries and adherence to Caristo's certification standards to ensure reliable longitudinal plaque and FAI-ScoreTM quantification. Any variability in image quality or protocol deviations would directly affect the primary endpoint measurement.

Watch for completion of site certification, first blinded 6-month analyses, and the 18-month primary endpoint readout; these milestones will determine whether measured changes in NCPV and FAI-ScoreTM support the trial's efficacy claims within the stated follow-up horizon.

NewAmsterdam REMBRANDT clinical trial to leverage Caristo CaRi-Heart® and CaRi-Plaque^TM technologies for coronary inflammation and plaque measurements and monitoring

STAMFORD, Conn. and OXFORD, England, Oct. 14, 2025 /PRNewswire/ -- Caristo Diagnostics, on a mission to transform the diagnosis and treatment of cardiovascular disease, announced its role as the worldwide imaging core lab for NewAmsterdam Pharma's REMBRANDT Cardiovascular Imaging Trial – overseeing all coronary plaque and inflammation measurements and monitoring.

The REMBRANDT trial, sponsored by NewAmsterdam Pharma (Nasdaq: NAMS), is a placebo-controlled, double-blind, randomized trial designed to assess the efficacy of obicetrapib and ezetimibe fixed dose combination (FDC) on coronary plaque burden. Obicetrapib is an investigational cholesteryl ester transfer protein (CETP) inhibitor that has shown to lower low-density lipoprotein cholesterol (LDL-C) in three Phase 3 clinical trials. Favorable changes in noncalcified coronary atherosclerotic plaque volume (NCPV) may indicate a potential beneficial effect on atherosclerotic cardiovascular disease (ASCVD) events¹.

Recently detailed in the American Heart Journal, REMBRANDT is recruiting patients from 50 sites in 7 countries (United States, Poland, United Kingdom, Czech Republic, Hungary, Italy and Spain). The trial's primary efficacy outcome is percent change in total NCPV from baseline to 18 months as assessed by coronary computed tomographic angiography (CCTA). Secondary endpoints include absolute change in total NCPV, percent and absolute change in NCPV, percent change in LDL-C, and change in perivascular fat attenuation index (FAI-Score^TM) which is Caristo's proprietary biomarker for coronary inflammation and an independent predictor of ASCVD events beyond plaque burden¹.

Caristo's core laboratory responsibilities for the REMBRANDT trial, include:

• Certifying and training each clinical site to ensure high-quality CCTA images
• Conducting baseline and follow-up analyses for all randomized patients at 6 and 18 months
• Measuring plaque burden, quantifying coronary inflammation using FAI-Score, and providing comprehensive cardiovascular risk calculations
• Ensuring rigorous image quality control, data anonymization, and radiation dose optimization

"We are proud to confirm Caristo's worldwide role in the REMBRANDT clinical trial," said Frank Cheng, CEO, Caristo Diagnostics. "Pharmaceutical and biotech sponsors are increasingly choosing Caristo to evaluate the effect of new drugs on both coronary plaque and inflammation. This growing confidence reflects our proven research capabilities and our technologies' ability to accurately detect coronary inflammation and plaque in support of the drug development process."

"Advances in CCTA imaging over the last few years are allowing us to perform high quality mechanistic studies that shed important light on a drug's mode of action," said Dr Cheerag Shirodaria, Honorary Consultant Cardiologist at Oxford University Hospitals NHS Foundation Trust. "The information provided by the REMBRANDT trial will provide clinicians with valuable information on the direct effects of obicetrapib on coronary plaque morphology."

"The REMRANDT trial and evaluation of the effects of obicetrapib on coronary plaque and inflammation metrics is an important part of New Amsterdam's clinical development program," said Professor John Kastelein, Co-Founder and Chief Scientific Officer at New Amsterdam Pharma. "We are delighted to have Caristo as a partner on our journey."

About Caristo Diagnostics
Caristo Diagnostics is a global leader in cardiovascular disease diagnostics and risk prediction, founded as a spin-out company from the University of Oxford. Caristo's award-winning technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear. In collaboration with leading hospitals, pharmaceutical companies and world's renowned scientists, Caristo is on a mission to save lives through early detection and personalized prevention. For more information, visit caristo.com. Find Caristo online on LinkedIn, YouTube, Instagram, and X.

¹ "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 Jul 17:290:325-338. doi: 10.1016/j.ahj.2025.07.012. Online ahead of print

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SOURCE Caristo Diagnostics

FAQ

What role will Caristo play in the REMBRANDT trial (NAMS)?

Caristo will serve as the worldwide imaging core lab, overseeing plaque and inflammation measurements, image QC, site training, and analyses at 6 and 18 months.

What is the REMBRANDT trial primary endpoint and timeline for NAMS?

The primary endpoint is percent change in total NCPV from baseline to 18 months assessed by CCTA.

How many sites and countries are recruiting for REMBRANDT (NAMS)?

REMbrandT is recruiting patients from 50 sites in 7 countries including the United States, Poland, UK, Czech Republic, Hungary, Italy and Spain.

Which biomarkers will REMBRANDT measure for inflammation in the NAMS trial?

REMbrandT will measure Caristo's proprietary FAI-Score (perivascular fat attenuation index) as a biomarker for coronary inflammation.

What treatments are being tested in REMBRANDT (NAMS)?

The trial tests an investigational obicetrapib and ezetimibe fixed dose combination (FDC) versus placebo in a randomized, double-blind design.