Endocrine disorders and metabolic dysfunction impose enormous costs on populations worldwide – personal, societal, medical, and financial – and chronic conditions are multiplying rapidly. Obesity, in particular, has serious effects on mental health, causing grave concerns, especially for young people. In an alarming projection, more than half of adults and a third of children and adolescents worldwide could be overweight or obese by 2050.1
Yet hope is on the horizon. For example, since the GLP-1 (glucagon-like peptide) receptor agonist, semaglutide was first approved for type 2 diabetes and subsequently for weight loss, we have seen a meteoric rise in the use of GLP-1 and related compounds with a high efficacy for weight loss and improving glucose-related parameters. For drug developers, the opportunity to bring innovative therapies to market is enormous; in fact, more than 100 anti-obesity drug candidates are in various stages of development. Along with opportunity, however, comes intense competition and risk.
Companies with established diabetes and obesity therapies must defend their market position from competitors by expanding their portfolios to treat different patient segments – possibly with precision medicine strategies – beyond obesity indications. On the other hand, companies seeking to enter the market need guidance about strategies for developing second-generation GLP-1s, combination therapies, and next-generation products for obesity and related cardiometabolic diseases, such as metabolic dysfunction-associated steatohepatitis (MASH).
Parexel is uniquely well positioned to support drug developers in these endeavors, with experience that is both broad and deep. Our team including board-certified adult and pediatric endocrinologists, and top-quality regulatory, market access, real world evidence, study design and biostatistics experts can fully support pharma clients with precisely defined market positioning, optimal trial designs and regulatory strategies. From small studies in rare metabolic diseases to large studies in obesity, osteoporosis and type 2 diabetes, our dedicated project teams identify the right sites through our strong global site networks and provide customized patient recruitment and retention strategies aimed at engaging the study participants and minimizing their study burden. We manage clinical trial delivery through partnership with our key vendors, as well as providing eCOA and sensor solutions, including continuous glucose monitoring and glucose-related data capture for diabetes clinical trials.
Obesity and Type 2 Diabetes Mellitus
From our experience in adult obesity and type 2 diabetes trials, we have found that there remains a high level of interest in obesity trials even in the U.S. where there are many competing trials. While this results in rapid patient enrollment, it is essential to ensure that the right patients are being screened who meet eligibility criteria and are motivated and willing to remain in the trial. Proactive discussions with sites throughout the enrollment period to evaluate and adjust site-specific strategies are key to recruiting the target patient population and accelerating processes. Our project teams have utilized dedicated patient retention strategies for obesity trials, addressing the key risks of discontinuation due to gastrointestinal side effects or to perceived lack of efficacy for patients who might be on placebo.
These strategies have resulted in a high rate of success in meeting trial milestones ahead of schedule. For example, in a global Phase II trial for adults with T2DM and adults with obesity, Parexel achieved rapid enrollment, with the T2DM arm completed in 3 months (5 weeks ahead of projected timeline). This seminal trial set a precedent for methodology, design, and operational delivery in obesity research.
Experience in the past 5 years
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Phase I to IV obesity and obesity-related clinical trials
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patients enrolled
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unique sites
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
In our extensive work in developing therapies in this area, Parexel has established best practices for patient enrollment and retention, site engagement, and minimizing lost-to-follow-up numbers. We have an established network of sites and investigators covering in the U.S., Europe, Asia, and Australia.
An example of a recent project is a Phase Ib trial to assess safety and tolerability of patients with obesity and hepatic steatosis. The complex study design included multiple dose groups and cohorts with mandatory 72-hour gaps between treatments, complicated by a demanding three-month schedule. Our team implemented innovative strategies and protocol amendments, along with a tool allowing a more flexible window for each study visit, which significantly improved study schedule compliance. We achieved the last patient/first visit milestone 76 days ahead of the contracted date.