GLP-1 therapies have undergone a remarkable transformation in recent years. Once considered a niche treatment for type 2 diabetes, GLP-1s have since gained rapid public attention driven by their effectiveness in weight management.

Today, adoption is accelerating globally at pace. Surveys suggest that around one in eight adults in the US has already used a GLP-1 drug, while in the UK it’s estimated that 1.6 million people have turned to these therapies for weight management in the past year alone.GLP-1 therapies have undergone a remarkable transformation in recent years. Once considered a niche treatment for type 2 diabetes, GLP-1s have since gained rapid public attention driven by their effectiveness in weight management. Today, adoption is accelerating globally at pace. Surveys suggest that around one in eight adults in the US has already used a GLP-1 drug, while in the UK it’s estimated that 1.6 million people have turned to these therapies for weight management in the past year alone.

This real-world uptake is mirrored in clinical research, as scientific interest in understanding the full therapeutic potential grows. Phesi’s recent analysis found obesity has become the sixth most studied disease area globally – an increase driven largely by GLP-1 innovation. While this investment brings opportunity, it also introduces new complexities for trial sponsors navigating a crowded and competitive landscape.

This real-world uptake is mirrored in clinical research, as scientific interest in understanding the full therapeutic potential grows. Phesi’s recent analysis found obesity has become the sixth most studied disease area globally – an increase driven largely by GLP-1 innovation. While this investment brings opportunity, it also introduces new complexities for trial sponsors navigating a crowded and competitive landscape.

Research indicates that GLP-1 therapies are well suited to addressing disease clusters. A strong case study is osteoarthritis. Affecting more than 500 million people worldwide, osteoarthritis is closely linked to obesity through increased mechanical stress on joints and systematic inflammation. Early research suggests that GLP-1-driven weight loss, combined with potential anti-inflammatory effects, could offer meaningful benefits in managing musculoskeletal health and treatment.

Similarly, metabolic dysfunction-associated steatohepatitis (MASH) has emerged as another focus area. As a progressive liver disease associated with obesity and metabolic syndrome, MASH represents a significant unmet clinical need. With limited treatment options currently available, GLP-1 therapies are being investigated for their ability to address both the metabolic and inflammatory components of the disease.

Along similar lines, cardiovascular disease is an area where GLP-1s are gaining traction. Previous studies have already demonstrated their ability to reduce cardiovascular risk in patients with diabetes and obesity. However, new research is beginning to explore even more ambitious applications. For instance, recent findings suggest that GLP-1 therapies could play a role in reducing complications following heart attacks, potentially improving outcomes by addressing issues such as impaired blood flow at the microvascular level.

Taken together, these developments highlight a fundamental shift in clinical development. Rather than targeting single diseases, GLP-1 trials are increasingly designed to address overlapping conditions that share common risk factors and biological pathways.

Cancer remains one of the most studied disease areas globally, reflecting both the scale of unmet need and the urgent need for new treatment options. With millions of new diagnoses each year, there is immense pressure for the clinical development industry to identify novel therapeutic approaches. GLP-1s have emerged as a key player in driving novel therapies.

There is a growing body of evidence linking metabolic dysfunction, obesity and cancer risk. Processes such as chronic inflammation, insulin resistance and altered cellular metabolism are known to play a role in tumour development and progression. By targeting these pathways, GLP-1 therapies could offer a new angle for intervention.

Early-stage research is beginning to investigate how GLP-1s might influence tumour biology, including their effects on insulin signalling and inflammatory processes. While this work is still in its infancy, it reflects a broader trend towards exploring the intersections between metabolic health and cancer.

Importantly, the expansion of GLP-1 research into oncology underscores the versatility of this drug class. It also highlights the potential for therapies originally developed for one purpose to unlock entirely new avenues of treatment. For both patients and clinicians, this represents a promising breakthrough in the pursuit for more effective and personalised cancer treatment.

While treating diseases as interconnected systems offers clear scientific advantages, it also introduces new layers of complexity. Patients enrolled in GLP-1 trials are increasingly likely to present with multiple comorbidities, making it more difficult to define inclusion criteria, select appropriate endpoints and interpret outcomes.

This complexity is already having a tangible impact on trial timelines. According to recent data, increased competition and demand in the obesity trial space have significantly extended cycle timelines (see figure 1). Trials that previously took between ten and 20 months are now often taking 25 to 45 months to complete. This not only increases costs for sponsors but also delays the delivery of treatments to patients.

At the same time, the growing use of GLP-1s in real-world settings is adding further complication. Many patients are now using these therapies alongside treatments for other conditions, such as hypercholesterolaemia and hyperlipidaemia. In some cases, GLP-1s are being used adjunctively in non-obesity indications, like osteoarthritis, where early findings indicate potential synergistic benefits. While this opens up exciting new possibilities, it underscores the need for more precise trial designs capable of capturing these indications.

To address these challenges, sponsors are increasingly turning to data-driven approaches. Tools such as Digital Patient Profiles offer a way to better understand patient populations by identifying patterns of comorbidity and treatment history. By leveraging these insights, researchers can optimise trial design to improve patient recruitment and generate more meaningful results. In an environment where speed and precision are critical, embracing data-led insights will play a key role in ensuring that the full potential of GLP-1 therapies can be realised.

As GLP-1 use becomes increasingly widespread in everyday healthcare, clinical development is evolving in parallel. With studies now exploring applications across more than 100 diseases, GLP-1s are establishing themselves as a powerful platform for understanding and treating complex, interconnected conditions.

For trial sponsors, this presents both an opportunity and a challenge. While the potential to explore new indications is significant, success will depend on the ability to adapt to a more complex and dynamic research landscape. This includes precisely designing trials that reflect the realities of multi-disease patient populations, as well as using clinical data science to navigate this complexity.

Looking ahead, GLP-1s are likely to remain at the forefront of pharmaceutical innovation. As research continues to uncover new applications, their role as a major disruptor in the industry will only grow. For sponsors able to harness their full potential, the rewards could be transformative, not just for drug development but for patient care as a whole.

Dr Gen Li is Founder and President of Phesi