13 Mar 2026
Cardiovascular and cardiometabolic diseases remain the leading cause of global morbidity and mortality1, and drug development in this space is more complex than ever. We spoke with Labcorp Biomarker Solution Center Director of Cardiometabolic Biomarkers, Sanda Ljubicic, MSc, PhD, about the evolving disease landscape, unique clinical trial challenges, and role of integrated biomarker and operational strategies in accelerating progress.
How would you describe the current landscape of cardiometabolic disease and therapy development?
The landscape is both urgent and incredibly dynamic. Cardiovascular and metabolic diseases deeply impact patients' lives and the whole healthcare system. Cardiovascular disease is no longer viewed in isolation; it’s deeply interconnected with metabolic, renal and inflammatory pathways, sharing common molecular mechanisms, biomarkers and sometimes even the same drug treatment. Conditions like obesity, diabetes, chronic kidney disease, dyslipidemia and steatotic liver diseases are now recognized as part of a broader cardiometabolic continuum.
Therapy development reflects this shift. We’re seeing an explosion of innovation, from GLP-1R - based therapies to next-generation lipid-lowering agents, anti-inflammatory approaches and RNA-based therapies targeting Lp(a). While scientifically exciting, these advances also increase complexity because trials must address multifactorial disease biology, heterogeneous patient populations and increasingly demanding endpoints.
This evolution requires biomarker strategies that go beyond single measurements. Success now depends on integrated insight, namely, understanding how inflammation, lipid metabolism, glycemic control, renal function, cardiac and vascular injury and liver disease intersect over time.
What are the biggest challenges unique to cardiovascular and cardiometabolic clinical trials today?
Trial complexity is the defining challenge. Even if cardiometabolic diseases share common traits in physiopathology, the protocols for testing drugs in these indications can have very different trial designs. Cardiometabolic studies often require large sample sizes, long durations (5-10 years is not uncommon) or long-term follow-ups, and complex, event-driven endpoints, all of which make these trials costly and resource intensive. As such, trial designs need to adapt to timelines, requiring meticulous preparation and a profound understanding of the endpoints and regulatory constraints. Recruitment and retention are also major hurdles. In Lp(a) and obesity studies, for example, screen failure rates can be high, and identifying eligible patients quickly can be difficult. The same is true for metabolic dysfunction–associated steatotic liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH) trials, which can have 70%-80%2 screen failure rates. Patients may also face a significant burden from frequent visits and invasive testing, such as tissue biopsy collection or other uncomfortable procedures, and medications with strong side effects that can impact retention over time.
From a testing perspective, there’s a critical need for globally harmonized biomarker panels and noninvasive testing solutions. Inconsistent assays, regional variability, or suboptimal sample handling can corrupt the data and delay decision making.
Operationally, the required infrastructure to manage global cardiometabolic trials combined with the pressure to accelerate timelines, manage risk and maintain data consistency at scale can be challenging. All of this is happening against the backdrop of intense innovation, particularly with the rapid pace of GLP-1R agonists and next-generation cardiometabolic therapies.
How does Labcorp help biopharma translate cardiometabolic complexity into actionable trial strategies?
At Labcorp, our focus is on translating scientific complexity into clear, actionable biomarker and operational strategies across the full clinical trial life cycle.
From a scientific perspective, we bring deep expertise across comprehensive cardiometabolic biomarkers, including markers of inflammation, lipid metabolism, glycemic control, renal function, cardiac and vascular injury, as well as biomarkers of liver injury, inflammation and fibrosis. We support both exploratory and validated biomarkers, aligned with regulatory expectations across the U.S., EU and APAC regions.
Equally important is our consultative approach; we work closely with sponsors to optimize biomarker selection, so it aligns with disease biology, clinical endpoints, patient stratification strategies and, even downstream, diagnostic development. This is particularly critical in cardiometabolic disease, where biology is interconnected and evolving.
But insight alone isn’t enough. Bridging scientific intent with ideal execution is where many trials succeed or fail.
What does that scientific–operational bridge look like in real-world cardiometabolic trials?
Consistency and visibility are everything in cardiometabolic trials, whether you’re running a rare disease study with a small number of patients or a global megatrial.
Labcorp Central Laboratory Services offers broad cardiometabolic assay availability across our global central labs and broader laboratory network, enabling harmonized data collection worldwide. Over the last five years alone, we’ve supported more than 8503 cardiometabolic studies, which speaks to both our scale and experience managing complexity.
Operationally, we provide standardized sample handling, validated assay performance and reliable logistics across regions. Tools like Labcorp Global Trial Connect™ provide real-time, end-to-end sample tracking, giving sponsors greater visibility into study operations and enabling faster, data-driven decisions.
This combination of biomarker expertise, operational rigor, and digital transparency reduces risk, minimizes variability, and ultimately helps sponsors stay on track despite the long timelines inherent to cardiometabolic research.
How is Labcorp helping sponsors address patient access, diversity, and engagement in cardiometabolic and weight management trials?
Reaching and retaining the right patients is one of the most pressing challenges in cardiometabolic research, particularly in high-risk and historically underserved populations.
Labcorp is uniquely positioned here. Through our patient service centers and community-based partnerships, including Acclinate and Circuit Clinical, we help expand access to diverse patient populations that are often underrepresented in clinical trials. Our proprietary data assets also enable more precise identification and engagement of patients with specific cardiometabolic profiles. In parallel, we support decentralized and patient-centric trial models, such as at-home sample collection and mobile healthcare providers. These approaches help reduce patient burden, improve accessibility for individuals with mobility or geographic limitations and ultimately support better retention over the long duration of cardiometabolic studies.
Looking ahead, what do you see as the future of cardiometabolic therapy development and trials?
The future is faster, more integrated and more patient-centric—but only if we rethink how trials are designed and executed.
Innovation isn’t slowing down. As GLP-1R agonists and next-generation cardiometabolic therapies continue to emerge, sponsors will need partners who can move quickly without compromising data quality or regulatory readiness. Biomarker strategies will become even more central to decision-making, serving as the connective tissue between disease biology, clinical outcomes and real-world impact.
In the future, preventive care, patient education and disease awareness will be the focus, alongside tailoring diet and more physical activity according to a patient’s genetic, microbiome, and metabolite profile for enhanced metabolic regulation will receive greater focus. Another critical aspect will be the focus on early screening and better risk assessment to uncover high-risk patients for cardiometabolic diseases, especially for MASH or prediabetes.
Moreover, there are different assets that will be developed to solve challenges relevant to GLP-1R agonist treatment that can also be applicable to therapies for cardiometabolic diseases, including long-term safety and tolerability, high cost (reimbursement) and accessibility, manufacturing and supply chain constraints, as well as patient adherence and compliance.
I also see a continued shift toward noninvasive testing, decentralized trial elements and advanced analytics, all aimed at reducing burden while increasing precision and alleviating patient discomfort. Ultimately, success in this space will depend on the ability to integrate scientific insight, global execution and patient engagement into a single, cohesive strategy.
That’s where Labcorp comes in—helping our biopharma and biotech partners solve the scientific, logistical and engagement risks of cardiometabolic clinical trials so promising therapies can reach patients sooner.
Access cardiometabolic insights from Labcorp: https://www.labcorp.com/biopharma/central-labs/therapeutic-experience/cardiometabolic
References
1. https://pmc.ncbi.nlm.nih.gov/articles/PMC12142050/
2. https://www.sciencedirect.com/science/article/pii/S2589555925000278
3. Labcorp internal data