Obesity
Interdisciplinary expertise in obesity research and related comorbidities
One billion people worldwide will be living with obesity by 2030 and the global disease burden continues to rise in adults and children.
As obesity rates continue to rise, the healthcare community is turning to medical interventions to counter this chronic condition and its multiple adverse health effects. As a risk factor for many other conditions, obesity poses challenges for clinical development across the full spectrum of this disease. ÃÛÌÒ´«Ã½ has the experience and cross functional expertise to help sponsors overcome the challenges associated with obesity research and clinical trials.
Obesity and beyond: Embracing multi-indication potential during clinical development
The obesity therapeutic marketplace has rapidly embraced multi-indication drug development, following successful label expansion of incretin agonists semaglutide and tirzepatide. Explore the rise of multi-indication drug development across cardiometabolic-related conditions and the strategies driving clinical and commercial success for molecules with broad potential.
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Accelerate your obesity program with speed, scale, and pre-identified patients
Whether you¡¯re advancing a large portfolio or moving toward proof of concept, ÃÛÌÒ´«Ã½¡¯s Centre for Obesity delivers expertise and market intelligence with a ready-to-deploy infrastructure to support early decision-making, proactive planning, and accelerated, high-quality study delivery.
- Comprehensive service portfolio supporting all aspects of obesity clinical development and commercialisation
- 100 sites and an in-development database of 10,000 pre-screened patients across the breadth of comorbidities
- Global laboratory network delivering timely, high-quality imaging, cardiac, and bioanalytical support
- Advanced clinical data suite for proactive trend analysis, safety monitoring, and secure patient data management
Therapeutic expertise
ÃÛÌÒ´«Ã½ has deep therapeutic expertise and experience with indications in:
Integrated approach to obesity studies
There is growing interest in the simultaneous development of assets with significant public health impact across multiple related indications. ICON is exploring potential advantages to innovative uses of master protocols, which are constructed to test multiple hypotheses with an overarching set of procedures intended to improve efficiency.
ÃÛÌÒ´«Ã½ offers the most comprehensive suite of integrated clinical development services for obesity trials in the industry. We¡¯ve designed flexible and fully customisable solutions to help our customers achieve their goals across a seamless delivery model spanning their product¡¯s entire lifecycle. From small early phase trials to larger pivotal or long-term outcomes trials, we work your way to deliver better outcomes.
Our full range of clinical development services across all phases of drug and device development provide a comprehensive solution for obesity trials.
- Clinical study design and execution A flexible approach to improve cycle times, constrain costs, and reduce risks through clinical trial planning, management, execution and analysis
- Central lab services A full range of central laboratory services that are dedicated exclusively to clinical development
- Site & Patient Solutions Patient centric clinical trial services increasing recruitment and retention
- Imaging and endpoint adjudication services Integrated solutions based on the science of imaging biomarkers
- Regulatory and QA support Strategic consulting and operational support in a complex environment
- Commercialisation and outcomes Integrated solutions to accelerate market access and drive product adoption
- Strategic resourcing Customised FSP models to drive operational efficiencies and accelerate clinical development
- Cardiac Safety Solutions End-to-end cardiac safety support for your clinical trials
Clinical study design and execution
A flexible approach to improve cycle times, constrain costs, and reduce risks through clinical trial planning, management, execution and analysis
Central lab services
A full range of central laboratory services that are dedicated exclusively to clinical development
Site & Patient Solutions
Patient centric clinical trial services increasing recruitment and retention
Imaging and endpoint adjudication services
Integrated solutions based on the science of imaging biomarkers
Regulatory and QA support
Strategic consulting and operational support in a complex environment
Commercialisation and outcomes
Integrated solutions to accelerate market access and drive product adoption
Strategic resourcing
Customised FSP models to drive operational efficiencies and accelerate clinical development
Cardiac Safety Solutions
End-to-end cardiac safety support for your clinical trials
Master protocol designs
Often, therapies are developed and tested in isolation rather than simultaneously for multiple related diseases. However, this framework is suboptimal for obesity and its interconnected conditions and comorbidities. Master protocol designs can create efficiencies in drug development for these interconnected therapeutic indications. ÃÛÌÒ´«Ã½ offers design, simulation and execution of adaptive and innovative clinical trials, including basket, umbrella and platform protocols.
Early phase obesity studies
ÃÛÌÒ´«Ã½ has proven success designing, managing, and executing early phase obesity studies enrolling overweight and obese volunteers. With a robust database of overweight/obese volunteers across our clinical research units we can rapidly meet key eligibility criteria and study milestone timelines. Over the last five years we have successfully achieved or exceeded enrolment targets across more than 35 early phase studies, with 95% retention rates, even for very long duration trials with multiple overnights and long follow-up periods.
Feasibility and site selection
Obesity clinical trials are usually long and complex, so it can be hard to accurately estimate enrolment and study timelines. To address this challenge, ÃÛÌÒ´«Ã½ has developed and licensed industry-leading tools to support all aspects of feasibility and site identification. With ÃÛÌÒ´«Ã½¡¯s award-winning AI-driven data aggregation and analysis platform, licensed partner data can be integrated with ÃÛÌÒ´«Ã½ performance data to predict which sites have the highest probability to enroll subjects.
Patient recruitment and retention
- Patient access continues to be one of the biggest industry challenges, impacting time and cost in clinical trials. ÃÛÌÒ´«Ã½'s FIRECREST Pre-Screen solution improves the speed and accuracy of the pre-screening process compared to other current paper-based and eScreen methods. The data harvested from the process is aggregated to form actionable insights into the key drivers of pre-screen success and failure.
- Working relationships with thousands of cardiovascular investigative sites across the globe helps tailor recruitment strategies to each study.
ÃÛÌÒ´«Ã½ uses a patient centric approach to provide study specific patient recruitment and engagement strategies on a global basis.
Patient-centric trials
Increasing patient centricity in clinical research is bringing benefits to both patients and sponsors. ÃÛÌÒ´«Ã½ provides Site & Patient Solutions that make it easier for the site and the patient to actively participate in a trial - an essential part of increasing predictability in enrolment and retention.
- Decentralised obesity clinical trials enhance patient experience, retention and compliance rates by connecting, monitoring and engaging patients at every step of the clinical trial journey with customised support service. ICON is already deploying decentralised clinical trials on a global basis in multiple therapeutic areas and will support you in navigating assessment, planning and execution for better outcomes.
- Digital health technology can support compliance and patient retention in obesity clinical trials. Our dedicated medical device and digital health technologies teams support device selection and digital endpoint validation.
- is ÃÛÌÒ´«Ã½¡¯s global clinical research network offering customers a wide range of stand-alone and integrated solutions for their studies, including patient assessments at our sites or in-home to reduce site and patient burden.
- Using digital patient recruitment and removing barriers, such as travel and complex trial logistics, increases access to diverse patient populations and underrepresented communities.
Cardiac Safety Solutions
Cardiac safety is a key component of any drug or device clinical trial, with regulatory authorities requiring sponsors to demonstrate cardiac safety for all drugs. The collection and reporting of high-quality data is therefore essential to drive decisions across all phases of drug development.
ÃÛÌÒ´«Ã½ offers a range of end-to-end cardiac safety services, including electrocardiography (ECG), event monitoring, blood pressure monitoring (BPM), long-term Holter monitoring, echocardiography (ECHO) and multi-gated acquisition scan (MUGA) studies. Our highly experienced team includes medical doctors, board-certified cardiologists, cardiovascular research scientists, and expert cardiac consultants who will support every aspect of your trial, including protocol design, statistical analysis, expert report writing and communication with regulatory agencies.
Medical Imaging
ÃÛÌÒ´«Ã½ provides end-to-end integrated solutions based on the science of imaging biomarkers via cutting edge technology and image analysis tools. We have medical imaging expertise with specialisations in multi-modal image acquisition (MRI-PDFF, MRE, CT, DXA) and processing expertise in MASH and obesity assessments. Our core team of more than 450 qualified clinical imaging professionals includes radiologists, imaging scientists, and certified imaging technologists. These highly trained and experienced experts will provide advice on imaging endpoints and the critical uses of imaging for the medical, scientific and regulatory aspects of your trial - enabling improved decision making and successful outcomes.
Data-driven solutions for commercialisation
Achieving regulatory approval is no longer enough to ensure commercial success. ÃÛÌÒ´«Ã½ supports commercial positioning with consulting and with Symphony Health, our integrated health data liquidity and analytics. Symphony Health supports an Integrated Dataverse (IDV?), one of the largest integrated repositories of healthcare data, which provides comprehensive coverage of pharmacy prescriptions and claims, medical claims, and institution claims and sales. Through cloud-based solutions and consulting services, sponsors gain a more holistic view of how payer, prescriber, and patient behaviour impact brand success.
Post market follow-up
The only way to prove the true value of a medical device or therapy is to collect real-world data (RWD) on its safety, efficacy and cost outcomes outside of the clinic. Long-term data is especially important for information on duration of treatment and dosage of new drugs. ÃÛÌÒ´«Ã½¡¯s tokenisation and real world data capabilities make this post market follow-up possible.
Obesity insights
ÃÛÌÒ´«Ã½'s therapeutic experts provide analysis including whitepapers, blogs and contributions to media and industry conversations relating to clinical trials for obesity and other interrelated conditions.