From Data to Delivery: Rethinking How We Conduct Metabolic Trials
Across the globe, metabolic and cardiometabolic diseases are rapidly becoming the most urgent public health challenges of the 21st century. In the United States alone, more than 37 million people are living with diabetes, and over 100 million adults are classified as obese. Hypertension and cardiovascular disease are prevalent across nearly every demographic, and conditions such as non-alcoholic steatohepatitis (NASH), dyslipidemia, and metabolic syndrome are on the rise. The toll these diseases take on public health, healthcare systems, and economic productivity is staggering, costing the U.S. billions annually in direct and indirect healthcare costs.
Simultaneously, a historic wave of innovation is sweeping through the pharmaceutical and biotech industries. Dozens of new therapies targeting metabolic and cardiometabolic conditions are now in development, many of them with the potential to not only treat but profoundly reshape the progression of these diseases. From GLP-1 receptor agonists and SGLT2 inhibitors to dual and triple incretin receptor agonists, FGF21 analogs, amylin mimetics, and more, these treatments are showing promise not just in weight loss or glycemic control, but in delivering real cardiovascular benefit and disease-modifying outcomes.
More than 80 pharmaceutical companies and dozens of contract research organizations (CROs) are actively investing in clinical trials for cardiometabolic diseases. These studies span a wide range of indications, from early-stage proof-of-concept trials in obesity to large cardiovascular outcomes studies evaluating long-term safety and efficacy of drugs. Sponsors are not only seeking high-performing sites, they are seeking networks that can support a pipeline of studies across multiple specialties, sites that offer consistency, scalability, and the ability to execute efficiently across overlapping conditions and endpoints.
Additionally, the complexity of these diseases requires clinical research sites that can handle not just one type of study, but an entire portfolio, from diabetes and obesity to hypertension, lipid disorders, kidney disease, and cardiovascular risk reduction. With many of these conditions interconnected, sponsors increasingly look for sites that can recruit patients across multiple specialties simultaneously and offer real-world continuity of care.
The momentum around these therapies has generated unprecedented interest and investment, with metabolic drugs now among the most actively pursued assets in the pharmaceutical pipeline. However, this surge in clinical innovation is creating an urgent need for equally innovative research infrastructure. The demand for real-world, high-quality sites that can recruit quickly, retain patients, and deliver clean, reliable data is intensifying.
The Clinical Research Bottleneck
As the volume of new therapies increases, trial execution has become increasingly difficult. Not due to a lack of innovation, but a lack of infrastructure to match it. Key pain points are well-documented across industry literature and stakeholder commentary, with patient access, trial complexity, and retention consistently ranking among the top concerns.
For example, Linical’s analysis of metabolic trial recruitment highlights that patients with diabetes and obesity often fall outside the reach of traditional research sites, largely because they are treated in primary or specialty care environments that are not affiliated with academic medical centers or standalone research institutions. These patients are more likely to trust and engage with trials if their existing providers are involved, a challenge for networks that operate outside the flow of clinical care.
Medpace’s overview of obesity trial design echoes this concern, pointing to logistical and eligibility barriers that prevent the inclusion of diverse patient populations. They also underscore the impact of complex comorbidities on protocol adherence and the need for highly coordinated, multidisciplinary care. As a result, retention becomes not just a downstream problem, but one shaped by how trials are designed and implemented from the outset.
Despite the expanding pool of therapies, the clinical trial infrastructure supporting metabolic research has not kept pace. Sponsors and contract research organizations (CROs) face increasingly complex challenges in executing these trials effectively:
Rethinking Trial Design for Metabolic Disease
Meeting the demands of modern metabolic research requires a different kind of clinical trial infrastructure. One that is fully integrated into everyday healthcare, designed around patient realities, and powered by technology.
At the heart of this transformation is the ability to access not just patients, but their providers and their data. Clinical trials for cardiometabolic diseases require longitudinal monitoring, lab work, specialist referrals, and real-time data review. When trials are embedded into a patient’s actual care setting, the provider becomes a partner in the research process, facilitating better recruitment, clearer communication, and stronger adherence. The electronic medical record (EMR) becomes a powerful research tool, enabling seamless pre-screening, ongoing safety tracking, and a full view of the patient’s history.
Importantly, the role of the provider cannot be overstated. When patients are approached about trial participation by the provider they know and trust, their willingness to enroll and remain increases significantly. Studies show that physician-led recruitment leads to higher engagement and better retention. Providers can reinforce adherence, manage comorbidities proactively, and coordinate trial activities as part of standard care.
Moreover, EMR integration allows for trial activity to be woven into the patient’s care pathway. From flagging patients for eligibility to tracking labs, prescriptions, and comorbid conditions, EMRs create a real-time recruitment and data collection engine. This ensures that eligible patients are not missed, and that trial data is captured at the point of care with minimal delay or error.
Access to both patient and provider is particularly critical for studies that involve multiple specialties, which are common in cardiometabolic research. For example, a trial involving GLP-1 therapies might require coordination between endocrinology, cardiology, nephrology, and nutrition services. The ability to manage all aspects within one system dramatically improves protocol adherence and simplifies study oversight.
Successful metabolic trials need:
In short, the future of metabolic research demands clinical trial sites that are not bolted onto care but embedded within it.
Innovo Research: Built for the Metabolic Research Era
Innovo Research is answering that call. As the burden of metabolic and cardiometabolic disease accelerates, Innovo has quietly built one of the most robust, efficient, and integrated research networks in the U.S., one purposefully designed to meet the complexity of today’s trials.
Operating within large, physician-owned, value-based care organizations, Innovo’s model brings research into real-world, multi-specialty clinics serving over 6 million patients across 9 states. These patients are cared for by more than 55 investigators specializing in endocrinology, cardiology, gastroenterology, internal medicine, and family medicine, often working under the same roof.
Innovo’s AI-driven platform connects the EMRs of partner clinics, enabling real-time identification of eligible patients. Trial procedures are performed in-house, from labs to imaging, reducing delays and improving data integrity. Through one contract and one budget, sponsors can activate multiple sites simultaneously, and start enrolling patients in weeks, not months.
With over 80 metabolic and cardiometabolic trials successfully completed, including studies in obesity, diabetes, NASH/MASH, cardiovascular outcomes, and hypertension, and an industry-leading retention rate of 98%, Innovo is positioned not just to participate in this new research era, but to lead it.
As the pharmaceutical and biotech industries continue to invest in therapies that promise to redefine cardiometabolic health, they’ll need site partners who are already living in the future of care. Innovo Research offers just that: real-world reach, real-time technology, and research truly embedded at the speed of care.