New ICON Survey Highlights Importance of Combination Therapies in Future Obesity Treatment

ICON plc, (NASDAQ: ICLR) a world-leading clinical research organisation powered by healthcare intelligence, today announced results from a recent industry survey of over 100 professionals engaged in obesity-related clinical research to measure industry opinions on trends within this therapeutic area. The majority of respondents believe the future of obesity therapies lies in trials that are designed to measure more than one outcome. There is much overlap between obesity and co-morbidities such as diabetes, steatosis (fatty liver), and cardiovascular disease, and in line with this, most respondents (64%) felt combination therapies would be the primary focus of future research. Furthermore, half of respondents are employing multi-indication studies in their current obesity-related clinical studies.

Obesity is a growing health concern worldwide, with at least 2.8 million people dying each year because of the disease¹. Two-thirds (66%) of respondents were confident in their obesity-related pipeline success prospects in the current market. They did, however, highlight challenges in obesity-related clinical studies around the current lack of long-term follow-up studies (44%), lack of appropriate obesity-specific trial design (39%), and difficulty in diverse patient recruitment (38%).

Simon Bruce, VP of Internal Medicine at ICON commented, "The focus on combination therapies cited by respondents is, in our view, indicative of the potential to make significant advancements in obesity clinical research in the coming years. There is more to examine on the implications of obesity as a risk factor across the disease spectrum and how it may impact treatment, drug development and clinical trials for obesity. We are seeing a growing interest in the simultaneous development of assets. This is something we are actively exploring at ICON in order to improve efficiencies, and to support more treatments to better meet the needs of the current population."

Sponsors must also invest in long-term studies in obesity to determine the lasting impact of effective treatments. This clinical data will help in terms of commercialising an obesity treatment and will benefit patients through the tracking of safety data for a longer period, in addition to demonstrating the impact of obesity drugs on longer-term co-morbidities such as heart disease or diabetes. Because obesity is so closely connected with such health events, treating obesity may reduce their occurrence ? and long-term data is important in determining a treatment's impact on them.

Jack Martin, Senior Director, Cardiovascular Therapeutics at ICON, points to the recent significant advances in the development of obesity-related treatments, from drugs to devices, commenting: "It has shone a light on the future potential of obesity treatment. The findings in this survey are constructive in identifying areas that we can focus on to continue these advancements. What's clear is that taking a holistic view of the disease and its related co-morbidities ? from diabetes to MASH and cardiac conditions ? is a hugely important consideration for the clinical trial design of potential new treatments."

Globally, there are currently more than 1,000 ongoing clinical trials² involving obesity drugs from pre-clinical to phase III trials. Many of the drugs being investigated are injectable and target GLP-1 hormone receptors and other hormones involved in satiety and metabolism, but others are exploring different mechanisms.

As researchers look to progress the field of obesity treatment, there are several unique considerations to account for in their approach to drug development and clinical trials. ICON has consolidated the latest thinking on current approaches to treating obesity and outlined considerations to improve future clinical trial design in the new whitepaper, entitled, "A multifaceted risk factor: Addressing obesity's impact across the disease spectrum". Highlights include:

• A look at the guidelines to treat obesity issued by various healthcare associations that advise a combination of lifestyle changes and pharmacotherapies, as well as more intense methods like bariatric surgery
• New pharmacological treatments currently in clinical trials, including several new GLP-1 receptor agonists, individually as well as in combination with other mechanisms, such as GIP and glucagon agonists
• Strategies to enhance recruitment among underrepresented populations to significantly increase the diversity of trials
• Using clinical trial tokenisation to gather real world data on the safety and effectiveness of a drug long after a trial has concluded, enabling deeper insights of disease and treatment patterns over time

For further information please visit www.iconplc.com/obesity.

About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 106 locations in 53 countries as at September 30, 2023. For further information about ICON, visit: www.iconplc.com.

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¹ Source: Obesity. https://www.who.int/news-room/facts-in-pictures/detail/6-facts-on-obesity

² Source: Global data: https://www.globaldata.com/data-insights/healthcare/number-of-ongoing-clinical-trials-for-drugs-involving-obesity-by-phase-505142/