The obesity market has experienced a significant surge in recent years, fueled by the rise of GLP-1 receptor agonists (GLP-1RAs). This surge has not only transformed treatment options but has also spurred a new wave of clinical trials, with companies like Novo Nordisk and Eli Lilly leading the charge.
Expansion Beyond Obesity
GLP-1RAs are now being tested beyond obesity, including in cardiovascular, neurodegenerative, and respiratory diseases. This expansion has led to a growing emphasis on decentralized clinical trials (DCTs) and advanced technologies that enable richer data collection and offer deeper insights into the daily experiences of patients using these drugs.
Decentralized Trials on the Rise
While the overall percentage of initiated DCTs has decreased since its peak in 2021, the number of decentralized obesity trials has increased during the same period. Sonia Bothorel, managing director at Mapi Research Trust, notes that digital health technologies (DHTs) like wearables, sensors, and apps have transformed how obesity trials are conducted, offering more granular data collection and enhancing participant engagement.
According to an analysis by Clinical Trials Arena, Novo Nordisk is at the forefront of using DCTs in obesity research, with semaglutide (marketed as Ozempic for type 2 diabetes and Wegovy for obesity) being the most frequently investigated drug in obesity DCTs.
Advantages and Challenges of DCTs
Dr. Benjamin Scirica, associate professor of medicine at Harvard Medical School, points out both pros and cons of employing DCTs. The SELECT trial (NCT03574597), sponsored by Novo Nordisk, which focused on the effect of semaglutide on mortality and Covid-19-related death, initially had a traditional design but transitioned to more decentralized features during the Covid-19 pandemic. This included more video consultations and medications being mailed to subjects.
While obesity DCTs can increase patient diversity, they also introduce digital literacy biases and concerns about the validity of remotely collected data. Scirica adds that using more decentralized tools can streamline trials and reduce costs, but this must be balanced with the potential for unknown harm and ensuring the quality of decentralized data collection methods.
The Role of Technology
The use of sensors, wearables, and home-captured data in obesity trials has improved, providing more granular data on patient activity and quality of life. Bothorel notes that data collection is increasingly taking place in participants’ natural environment thanks to sensors and other digital tools that enable remote monitoring, ensuring clinical trial data reflect participants’ real-life experiences.
Telemedicine is the leading virtual tool used in obesity DCTs, utilized in 38.5% of all obesity DCTs, followed by digital data collection, remote monitoring by a sensor, device or tracker, and remote monitoring of blood pressure/glucose.
Quality of Life Measures
Data shows that quality of life (QoL) measures are the third most utilized endpoint in obesity DCTs, after efficacy and safety. These measures track the overall well-being of patients by measuring their physical, emotional, and social functioning during and after treatment. Bothorel explains that with the increasing user and regulatory acceptance of DHTs like smartwatches and health-tracking apps, researchers can now access continuous, objective measurements such as continuous glucose monitoring, physical activity, heart rate, sleep patterns, mobility, and even mood.
The Future of Obesity Trials
Jack Martin, senior director of cardiovascular therapeutics and drug development solutions at ICON, estimates that by 2030, one billion people will be living with obesity globally. He anticipates increased investment in long-term follow-up studies to maintain weight loss and prevent adverse clinical events associated with obesity-connected comorbidities such as heart disease or diabetes.
Martin says conducting these long-term follow-up trials is costly and challenging, and there will be an increased focus on improving the efficiency, retention, and compliance within these trials. This can be driven by easing patient burden with decentralized and hybrid approaches to follow up and implementing tokenization to protect against loss of endpoint data.
Scirica notes that the focus of obesity trials has shifted from demonstrating safety to showing reductions in clinical events like heart attacks and strokes. The SELECT study, which showed a reduction in events like heart attacks, strokes, and death in addition to weight loss with Wegovy, has changed the overall objective of these studies, requiring them to be superiority studies with larger sample sizes and longer durations.
