Obesity clinical trials: tackling one of the world’s most serious health challenges

Obesity, defined by the World Health Organization as a “abnormal or excessive fat accumulation that presents a risk to health”*, is surging around the world. Less active lifestyles and the rise of ultra-processed foods are both factors in the global obese population doubling between 1990 and 2022.

In many western countries, in particular, the percentage of the population deemed obese is often far higher than the global average. The UK (25.9%^†), USA (41.9%^‡), Canada (30%^§), Germany (19%^¶), Australia (31.7%^#) all have significantly larger obesity rates than the global one in eight (12.5%^♠) figure established in peer-reviewed research published in early 2024.

The resulting health impacts and pressures on health services are unquestionably severe. As an established risk factor for several chronic diseases, including diabetes, heart disease, and cancers, tackling the world’s obesity epidemic is perhaps one of the single most effective ways of dramatically improving global health and life expectancy.

Obesity research determined to make impactful progress

Research scientists are working tirelessly, through a wide range of ongoing obesity clinical trials, to help find the best possible treatment methods. Some of these trials are already beginning to reveal promising results.

In August 2024, the results of a 176- week SURMOUNT-1 phase 3 study into the effects of tirzepatide were published by Eli Lilly^♥. There was much reason for encouragement. Researchers found that weekly tirzepatide injections reduced the risk of type 2 diabetes by 94% among adults with pre-diabetes and obesity or overweight. The results followed a similarly encouraging results analysis taken 72 weeks into the study.

The previous year, Novo Nordisk revealed that a 68-week phase 3a trial had found a “statistically significant and superior weight loss” among participants who had taken 50mg doses of oral semaglutide (commercially known as Wegovy) against those who had received a placebo^✦. Participants taking oral semaglutide had recorded an average 17.4% weight loss (versus 1.8% for placebo).

Novo Nordisk is also conducting a phase 3 trial assessing the impact of oral semaglutide partnered with an amylin analogue^♣. A randomized trial of 3,400 non-diabetic participants with obesity is expected to report its findings late in 2024.

Obesity-related decentralised clinical trials

In line with other treatment areas, many obesity clinical trials are now either entirely decentralised or operate a hybrid model, combining both remote data collection and on-site visits. This presents several new opportunities for CROs and research teams to achieve accurate, fast results from a diverse participant population. However, it can also create challenges – especially with the identification, supply, and shipping logistics of appropriate equipment.

Over the last 35 years, Woodley Trials Solutions has amassed extraordinary experience in supplying clinical trials all over the world. As research methods have adapted, our logistics and supply chain investments have enabled us to continue to provide the highest possible service to CROs and trial organisers, regardless of their location.

Our team’s vast product knowledge and medical devices regulation (MDR) understanding provides confidence from the outset. Researchers know that we work in partnership with them to identify only the most suitable products for their studies, shipping them wherever they are required, providing a full calibration service when necessary, and providing product training where appropriate.

Connected devices are an ongoing speciality. Across scales, spirometers, metabolic monitoring, ECG/EKGs, and BPMs, we’re ready to assist with everything you need to make your decentralised clinical trial safe, reliable, and fully successful in its data collection.

If you’re a CRO looking for equipment expertise, support, and regulatory knowledge for your next obesity clinical trial, contact us today. Our friendly team will be happy to help.