The World Health Organization has called obesity “one of today’s most blatantly visible – yet most neglected – public health problems”, describing the situation as “an escalating global epidemic of overweight and obesity”. Epidemiology data from GlobalData supports the growing severity of the issue. In the seven major pharmaceutical markets (US, France, Germany, Italy, Spain, UK, and Japan), the population affected by obesity is expected to grow at an annual rate of 0.57%, reaching over 161.5 million cases by 2033. Obesity rates are also on the rise in low and middle-income countries.

The obesity drug development space has experienced significant growth in recent years, marked by a notable increase in clinical trial activity. A total of 416 new obesity trials were initiated in 2024, representing a 60% increase from the average of 260 trials per year between 2016 and 2022.

This trend is expected to continue into 2025 and beyond. In GlobalData’s annual State of the Biopharmaceutical Industry 2025 survey, respondents identified anti-obesity medications as the most significant trend for the year.  Survey results indicated that 25% of respondents believe this trend will have the greatest impact on the sector, an increase of 7% from the previous year’s survey.

Latest generation of diabetes drugs triggers revolution in obesity space

Obesity is closely linked to a heightened risk of Type 2 diabetes – a life-threatening metabolic disease that affects an estimated 10.5% of the world’s adult population, according to the International Diabetes Federation. By 2045, it is projected that 1 in 8 adults will be affected.

Diabetes management traditionally relied on daily insulin injections and lifestyle changes. More recently, a new class of medicines known as glucagon-like peptide 1 receptor agonists (GLP-1 receptor agonists) achieved significant commercial success by revolutionizing treatment with once-weekly injections that regulate blood sugar levels, representing a major improvement in convenience for patients. While they can be used as an alternative to, or in combination with, insulin, they do not fully replace insulin therapy. Researchers quickly identified weight management as an additional benefit of these drugs, leading to several GLP-1 therapies receiving marketing authorizations specifically for weight loss.

Costanza Alciati, pharmaceutical analyst at GlobalData, comments: “The introduction of GLP-1 receptor agonists represents a groundbreaking advancement in obesity treatment. Novo Nordisk’s Wegovy can facilitate up to 15% bodyweight reduction, while Eli Lilly’s Mounjaro demonstrated even greater efficacy, exceeding 20% reduction in bodyweight in trial subjects. These results almost match the effectiveness of bariatric surgery and are unheard of in the obesity space.”

GlobalData’s 68-Market Drug Forecast and Market Analysis report on GLP-1 receptor agonists in Type 2 diabetes and obesity forecasts the market to reach $168.1 billion in sales by 2033.

“We are witnessing a revolution in the obesity space and there is a large enough patient population for multiple companies to share the market and try to address the global epidemic,” says Alciati. “GlobalData expects even more companies to join the race in the next months, and more investment being directed into this therapeutic area.”

Patient-centric strategies are instrumental to wider participation in metabolic trials

As investment and activity grow in the metabolic disease space, sponsors’ focus on improving the reach and efficiency of clinical studies is expected to intensify. Enrollment and retention, in particular, remain key challenges in the field.

Studies show that obesity and diabetes rates vary by race and ethnicity. In the United States, for example, non-Hispanic Black adults have the highest rates of severe obesity among all ethnic groups, at 13.8%, while Hispanic adults have the second highest prevalence at 7.9%. When it comes to diabetes, US demographics indicate that Native American adults have the highest prevalence of diagnosed diabetes, at 13.6%. This was followed by non-Hispanic Black adults at 12.1% and adults of Hispanic origin at 11.7%.

Many individuals living with obesity come from socioeconomically disadvantaged backgrounds, which may further limit access to healthcare and clinical trials. Participation in a clinical trial often requires significant time and commitment, and traditional site-based models may not align with the needs or lifestyles of the target demographic.

In addition to socioeconomic factors, the associated effects of the disease itself – particularly in severe cases –  can lead to reduced mobility and may exacerbate mental health struggles, further complicating participation challenges. For example, one study from 2006 linked a BMI of 35 or over with a 75% increased risk of becoming homebound. Meanwhile, a 2010 review of 15 studies discovered that people with obesity had a 55% increased risk of developing depression, and a 2020 review found that children and adolescents with obesity are almost twice as likely to experience major depressive disorder.

Unfortunately, the social stigma and discrimination that often surrounds obesity can increase the psychological distress of the condition, a problem evident in healthcare settings as well. In one study, 53% of people who were overweight or obese reported receiving inappropriate comments from their doctor about their weight.

Overall, a complex web of sensitive factors is involved in this area. There is a pressing need for diabetes and obesity trials to adopt more inclusive, patient-centric strategies to ensure that study populations accurately reflect the demographics of the populations affected by the diseases. Additionally, study teams should aim to be considerate and understanding to accommodate participants and take necessary steps to ensure their comfort.

Mobile research and community sites – the perfect solution?

Since 2018, 12% of all clinical trials in the metabolic disease therapy area have utilized one or more elements of decentralization – 5% higher than the average of 7% across all therapy areas. In trials focused specifically on obesity and diabetes, the rate of adoption was even higher at 14%.

Incorporating elements of decentralization into a trial typically aims to improve the participant’s experience, which can help address common challenges sponsors face with enrollment, engagement, and retention. This approach may include the use of digital technologies and wearable devices to monitor and communicate with patients remotely, thereby reducing the number of necessary visits to the site while simultaneously boosting the quantity of biometric data that can be collected throughout the trial. When possible, traditional site-based activities, such as the administration of investigational medicinal product (IMP), sample collection, and physical examinations can be performed by mobile clinicians directly at a participant’s location to support the study protocol.

PCM Trials has been pioneering this approach to mobile research solutions since 2008, bringing clinical trials directly to participants through mobile visits in over 80 countries. Their expert mobile clinicians extend the reach of research sites, reducing patient burden while ensuring study visits meet or exceed the standards expected by sponsors, CROs, and sites. More recently, the company acquired Europe’s longest standing mobile research provider, Clinical Trial Service, further strengthening its ability to deliver compliant mobile visits globally.

Community research in metabolic diseases – a case study

In 2024, PCM Trials expanded its clinical trial reach by acquiring EmVenio Research. EmVenio Research is the largest provider of community-based clinical trial sites, featuring mobile units strategically embedded in local communities. This community-based approach recently yielded impressive results in a weight loss study involving participants with and without Type 2 diabetes.

Two new community research sites in Oklahoma City and Phoenix were operationalized and dedicated for the study, and community outreach efforts commenced right away with the goal of pre-identifying potential participants.

EmVenio’s on-site team provided free health scans to members of the local community, successfully identifying 64% of participants through these efforts. Notably, 64% of the participants reported belonging to traditionally underrepresented groups, including 32% African American, 12% Native American, and 15% Hispanic.

Through a partnership with Prime Healthcare, EmVenio Research is establishing a growing number of hospital-based research centers within Prime’s pre-existing community hospitals. These centers, equipped with a full range of capabilities such as diagnostic procedures and imaging services, are strategically located in historically research-naïve areas, furthering EmVenio’s mission to expand clinical trial access to underrepresented populations.

The combined, community-based research solutions offered by PCM Trials, Clinical Trial Service, and EmVenio Research address challenges like mobility issues and geographic barriers for patients with obesity and diabetes. This patient-centric local access model can also help sponsors meet their enrollment targets and ensure that study populations reflect the real-world demographics of the disease being studied.

To learn more about the importance of advancing hybrid clinical trials with patient optionality, please download the whitepaper below.