Obesity

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But, obesity’s role as a chronic condition and a risk factor for many diseases poses challenges for clinical development. ICON has the experience and expertise to help sponsors overcome the challenges associated with obesity research and clinical trials.</p></div> </div> </div> </div> </div> </div> </div> </div> </div><div id="00ae5d13-c313-484d-ba94-3434e1bdcf86"> <div> <div class="file file--with-thumbnail"> <div class="container-fluid container-fluid--xl"> <a href="/insights/therapeutics/endocrine-and-metabolic-disorders/obesity/addressing-obesitys-impact" target="_self" title="Whitepaper: A multifaceted risk factor: Addressing obesity's impact across the disease spectrum"> <span class="file__thumbnail"> <div> <div><div><img src="https://icon.widen.net/content/19fac9e6-1971-44cc-af48-d0dd6bcad2e3/web/Obesity_whitepaper_thumbnail.png?h=240&itok=xWU8Cxsr" width="170" height="240" alt="Obesity_whitepaper_thumbnail.png" loading="lazy" title="Obesity_whitepaper_thumbnail.png" /> </div> </div> </div> </span> <span class="file__details"> <h3>Whitepaper: A multifaceted risk factor: Addressing obesity's impact across the disease spectrum</h3> <p>With obesity as a risk factor across the disease spectrum, there are several unique considerations and strategies for sponsors and researchers to account for in their approach to development and clinical trials for obesity treatment. Download the whitepaper to learn more.</p> </span> </a> </div> </div> </div> </div> <div id="db5233ea-d80e-4562-b719-cb7372f3e5f8"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h2>Cross-disciplinary therapeutic area expertise</h2> <h3> </h3> <div><p>ICON’s approach to obesity research draws on <a>therapeutic expertise from the many interrelated conditions linked to obesity</a>. We bring together experts across a broad range of therapeutic areas, device development, innovation technology, translational, regulatory, and real world evidence, for a comprehensive approach to asset development. ICON has deep expertise in:</p><ul><li><a href="/therapeutics/internal-medicine-immunology/rheumatology">Autoimmune diseases</a></li><li><a href="/therapeutics/cardiovascular">Cardiovascular</a></li><li><a href="/therapeutics/endocrine-metabolic-disorders">Endocrine and metabolic disorders</a></li><li><a href="/therapeutics/internal-medicine-immunology/gastrointestinal">Gastrointestinal disorders</a></li><li><a href="/therapeutics/endocrine-metabolic-disorders/non-alcoholic-steatohepatitis-nash">Hepatology including MASH</a></li><li><a href="/therapeutics/internal-medicine-immunology">Internal medicine and immunology</a></li><li><a href="/therapeutics/oncology">Oncology</a></li><li><a href="/therapeutics/paediatrics">Paediatrics</a></li><li><a href="/therapeutics/womens-health">Women's health therapeutics</a></li></ul></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="7982ea9c-f141-473b-9c34-6043d030aab2"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h2>Integrated approach to obesity studies</h2> <h3> </h3> <div><p>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.</p><p>ICON 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.</p><p>Our full range of clinical development services across all phases of drug and device development provide a comprehensive solution for obesity trials.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="15848b10-7352-43c5-91ff-84184708485a"> <div class="group transparent area-wrapper"> <div class="container-fluid container-fluid--xl"> <div class="area area--nav-left"> <ul class="area__nav area__nav--green"> <li> <a href="/solutions/consulting/asset-development" class="area__nav-item active has-link" target="_self" data-target="#area-item-0-142901-133221"> <span class="area__nav-title">Strategic planning</span> <span class="area__nav-description">Global, robust integrated asset development consulting, covering all phases of drug development enabling more cost-effective and timely product and drug development programmes</span> </a> </li> 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data-responsive-background-lg="https://icon.widen.net/content/6f61d12c-a380-4fa3-ad02-29f7bfc8e3ab/web/boardroom-meeting.jpg?crop=yes&w=1929&h=725&a=0,173&itok=f64AjDGM" data-responsive-background-md="https://icon.widen.net/content/6f61d12c-a380-4fa3-ad02-29f7bfc8e3ab/web/boardroom-meeting.jpg?crop=yes&w=1414&h=1069&a=258,0&itok=WS035bzW" class="area__content-item has-link" id="area-item-6-142901-133251" href="/solutions/strategic-solutions" target="_self"> <div class="area__content-item-overlay area__content-item-overlay--green-dark"></div> <h3 class="area__content-item-title">Strategic resourcing </h3> <p class="area__content-item-description">Customised FSP models to drive operational efficiencies and accelerate clinical development</p> <div class="btn btn-outline-white">Explore</div> </a> </div> </div> </div> </div> </div> <div id="7b9140b7-b3bc-4f70-ae42-75520aef4e61"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> </h3> <div><h4><strong>Master protocol designs</strong></h4><p>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. ICON offers design, simulation and execution of <a href="/solutions/consulting/asset-development/adaptive-trials">adaptive</a> and innovative clinical trials, including basket, umbrella and platform protocols.</p><h4><strong>Early phase obesity studies</strong></h4><p>ICON has proven success designing, managing, and executing <a href="https://www.iconplc.com/solutions/early-clinical/early-phase-obesity-trials">early phase obesity studies</a> 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.</p><p><strong>Feasibility and site selection</strong></p><p>Obesity clinical trials are usually long and complex, so it can be hard to accurately estimate enrolment and study timelines. To address this challenge, ICON has developed and licensed industry-leading tools to support all aspects of <a href="/solutions/clinical-scientific-operations/site-identification-and-feasibility">feasibility and site identification</a>. With ICON’s award-winning <a href="/solutions/technologies/one-search">AI-driven data aggregation and analysis platform</a>, licensed partner data can be integrated with ICON performance data to predict which sites have the highest probability to enroll subjects.</p><h4>Patient recruitment and retention</h4><ul><li>Patient access continues to be one of the biggest industry challenges, impacting time and cost in clinical trials. ICON's <a href="/solutions/technologies/firecrest">FIRECREST</a> 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.</li><li>Working relationships with thousands of <a href="/therapeutics/cardiovascular">cardiovascular</a> investigative sites across the globe helps tailor recruitment strategies to each study.</li><li><p>ICON uses a patient centric approach to provide study specific patient recruitment and engagement strategies on a global basis.</p><p><strong>Patient-centric trials</strong></p><p>Increasing patient centricity in clinical research is bringing benefits to both patients and sponsors. ICON provides <a href="/solutions/site-and-patient-solutions">Site & Patient Solutions</a> 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.</p></li><li>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 <a href="/solutions/decentralised-clinical-trials">decentralised clinical trials</a> on a global basis in multiple therapeutic areas and will support you in navigating assessment, planning and execution for better outcomes.</li><li>Digital health technology can support compliance and patient retention in obesity clinical trials. Our dedicated <a href="/sectors/medical-device">medical device</a> and digital health technologies teams support device selection and digital endpoint validation.</li><li><a href="https://www.accellacare.com/" target="_blank">Accellacare</a> is ICON’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. </li><li>Using digital patient recruitment and removing barriers, such as travel and complex trial logistics, increases access to diverse patient populations and underrepresented communities.</li></ul><h4><strong>Cardiac Safety Solutions</strong></h4><p>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.</p><p>ICON offers a range of <a href="/solutions/cardiac-safety-solutions">end-to-end cardiac safety services</a>, 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.</p><h4><strong>Medical Imaging</strong></h4><p>ICON provides end-to-end integrated solutions based on the science of imaging biomarkers via cutting edge technology and image analysis tools. We have <a href="/solutions/medical-imaging">medical imaging expertise</a> with specialisations in multi-modal image acquisition (MRI-PDFF, MRE, CT, DXA) and processing expertise in<a href="/therapeutics/endocrine-metabolic-disorders/non-alcoholic-steatohepatitis-nash"> MASH</a> 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.</p><h4><strong>Data-driven solutions for commercialisation</strong></h4><p><a href="/solutions/consulting/regulatory-affairs-consulting">Achieving regulatory approval</a> is no longer enough to ensure commercial success. ICON supports <a href="/solutions/consulting/commercial-positioning-consulting">commercial positioning</a> with consulting and with <a href="https://www.iconplc.com/solutions/technologies/symphony-health/">Symphony Health</a>, our integrated health data liquidity and analytics. Symphony Health supports an <a href="/solutions/symphony-health/integrated-dataverse-and-source-solutions">Integrated Dataverse (IDV®)</a>, 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.</p><h4><strong>Post market follow-up</strong></h4><p>The only way to prove the true value of a medical device or therapy is to collect <a href="/solutions/real-world-intelligence">real-world data (RWD)</a> 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. ICON’s <a href="https://www.iconplc.com/solutions/real-world-intelligence/clinical-trial-tokenisation/">tokenisation</a> and <a href="https://www.iconplc.com/solutions/real-world-intelligence/rwe-strategy-analytics/">real world data</a> capabilities make this post market follow-up possible.</p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="909c8052-fa55-4862-b682-9f9472da0da0"> <div class="bg-green-light"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Obesity insights </h3> <div><p>ICON'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.</p></div> <a class="btn btn-primary btn-md" href="/insights/therapeutics/endocrine-and-metabolic-disorders/obesity" target="_self">Read more</a> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </second> </div> <div class="col-md-3 order-1"> <div id="1e06578f-62f3-491e-a5ca-74afa1cbfa01"> <div class="container-fluid container-fluid--xl sidebar-menu-wrapper"> <div class="sidebar"> <div class="sidebar sidebar--sticky sidebar--collapsible"> <a class="sidebar--collapsible__toggle collapsed" role="button" data-toggle="collapse" href="#sidebar-content" aria-expanded="false" aria-controls="sidebar-content"> <span>In this section</span> </a> <div class="sidebar--collapsible__content collapse" id="sidebar-content"> <div class="sidebar--menu"> <h6 class="d-none d-md-block">In this section</h6> <ul class="sidebar--collapsible__list"> <li> <a href="/therapeutics/biosimilars" data-drupal-link-system-path="node/33807">Biosimilars</a> <div class="collapse " id="biosimilars-10484" > </div> </li> <li> <a href="/therapeutics/cardiovascular" title="ICON has extensive experience in cardiovascular clinical research trials across the entire drug development spectrum." data-drupal-link-system-path="node/34066">Cardiovascular</a> <div class="collapse " id="cardiovascular-10511" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#cell-and-gene-therapies-10512"></span> <a href="/therapeutics/cell-and-gene-therapies" data-drupal-link-system-path="node/34067">Cell and Gene Therapies</a> <div class="collapse " id="cell-and-gene-therapies-10512" > <ul class="menu menu-level-1"> <li> <a href="/insights/value-based-healthcare/the-affordability-hurdle-for-gene-therapies" data-drupal-link-system-path="node/33755">The affordability hurdle for gene therapies</a> <div class="collapse " id="cell-and-gene-therapies-the-affordability-hurdle-for-gene-therapies-10513" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#central-nervous-system-10514"></span> <a href="/therapeutics/central-nervous-system" data-drupal-link-system-path="node/34071">Central Nervous System</a> <div class="collapse " id="central-nervous-system-10514" > <ul class="menu menu-level-1"> <li> <a href="/therapeutics/central-nervous-system/cns-neurology" data-drupal-link-system-path="node/34068">CNS Neurology</a> <div class="collapse " id="central-nervous-system-cns-neurology-10515" > </div> </li> <li> <a href="/therapeutics/central-nervous-system/cns-pain" data-drupal-link-system-path="node/34069">CNS Pain</a> <div class="collapse " id="central-nervous-system--cns-pain-10516" > </div> </li> <li> <a href="/therapeutics/central-nervous-system/cns-psychiatry" data-drupal-link-system-path="node/34070">CNS Psychiatry</a> <div class="collapse " id="central-nervous-system---cns-psychiatry-10517" > </div> </li> <li> <a href="/insights/therapeutics/central-nervous-system/challenges-and-opportunities-in-traumatic-brain-injury-clinical-trials" data-drupal-link-system-path="node/33678">Challenges and opportunities in traumatic brain injury clinical trials</a> <div class="collapse " id="central-nervous-system----challenges-and-opportunities-in-traumatic-brain-injury-clinical-trials-10518" > </div> </li> <li> <a href="/insights/therapeutics/central-nervous-system/key-considerations-for-parkinsons-disease-trials" data-drupal-link-system-path="node/33680">Challenges and opportunities in Parkinson’s Disease clinical trials</a> <div class="collapse " id="central-nervous-system-----challenges-and-opportunities-in-parkinson-s-disease-clinical-trials-10519" > </div> </li> <li> <a href="/insights/therapeutics/central-nervous-system/key-considerations-in-chronic-pain-clinical-trials" data-drupal-link-system-path="node/33681">Key considerations in chronic pain clinical trials</a> <div class="collapse " id="central-nervous-system------key-considerations-in-chronic-pain-clinical-trials-10520" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class=" " data-toggle="collapse" role="button" href="#endocrine-metabolic-disorders-10521"></span> <a href="/therapeutics/endocrine-metabolic-disorders" data-drupal-link-system-path="node/34072">Endocrine & Metabolic Disorders</a> <div class="collapse show" id="endocrine-metabolic-disorders-10521" > <ul class="menu menu-level-1"> <li> <a href="/therapeutics/endocrine-metabolic-disorders/obesity" class="active is-active" data-drupal-link-system-path="node/38991">Obesity</a> <div class="collapse show" id="endocrine-metabolic-disorders-obesity-11021" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#endocrine-metabolic-disorders--metabolic-dysfunction-associated-steatohepatitis-mash--10522"></span> <a href="/therapeutics/endocrine-metabolic-disorders/non-alcoholic-steatohepatitis-nash" data-drupal-link-system-path="node/34073">Metabolic dysfunction-associated steatohepatitis (MASH)</a> <div class="collapse " id="endocrine-metabolic-disorders--metabolic-dysfunction-associated-steatohepatitis-mash--10522" > <ul class="menu menu-level-2"> <li> <a href="/insights/therapeutics/nash/the-voice-of-nash-investigators-in-patient-recruitment" data-drupal-link-system-path="node/33694">The voice of NASH investigators</a> <div class="collapse " id="metabolic-dysfunction-associated-steatohepatitis-mash--the-voice-of-nash-investigators-10523" > </div> </li> </ul> </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#infectious-diseases-10524"></span> <a href="/therapeutics/infectious-diseases" data-drupal-link-system-path="node/34076">Infectious Diseases</a> <div class="collapse " id="infectious-diseases-10524" > <ul class="menu menu-level-1"> <li> <a href="/insights/therapeutics/infectious-diseases/antimicrobial-resistance" data-drupal-link-system-path="node/33685">Antimicrobial resistance</a> <div class="collapse " id="infectious-diseases-antimicrobial-resistance-10525" > </div> </li> <li> <a href="/insights/therapeutics/infectious-diseases/hiv" data-drupal-link-system-path="node/33689">HIV</a> <div class="collapse " id="infectious-diseases--hiv-10526" > </div> </li> <li> <a href="/insights/therapeutics/infectious-diseases/covid-19-vaccine-trials" data-drupal-link-system-path="node/33687">Pandemic respiratory vaccine clinical trials</a> <div class="collapse " id="infectious-diseases---pandemic-respiratory-vaccine-clinical-trials-10527" > </div> </li> </ul> </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#internal-medicine-immunology-10528"></span> <a href="/therapeutics/internal-medicine-immunology" data-drupal-link-system-path="node/34080">Internal Medicine & Immunology</a> <div class="collapse " id="internal-medicine-immunology-10528" > <ul class="menu menu-level-1"> <li> <a href="/therapeutics/internal-medicine-and-immunology/dermatology" data-drupal-link-system-path="node/34077">Dermatology</a> <div class="collapse " id="internal-medicine-immunology-dermatology-10529" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#internal-medicine-immunology--gastrointestinal-10530"></span> <a href="/therapeutics/internal-medicine-immunology/gastrointestinal" data-drupal-link-system-path="node/34078">Gastrointestinal</a> <div class="collapse " id="internal-medicine-immunology--gastrointestinal-10530" > <ul class="menu menu-level-2"> <li> <a href="/therapeutics/internal-medicine-and-immunology/gastrointestinal/inflammatory-bowel-disease" data-drupal-link-system-path="node/34079">Inflammatory Bowel Disease</a> <div class="collapse " id="gastrointestinal-inflammatory-bowel-disease-10531" > </div> </li> </ul> </div> </li> <li> <a href="/therapeutics/internal-medicine-immunology/ophthalmology" data-drupal-link-system-path="node/34081">Ophthalmology</a> <div class="collapse " id="internal-medicine-immunology---ophthalmology-10532" > </div> </li> <li> <a href="/therapeutics/internal-medicine-immunology/respiratory" data-drupal-link-system-path="node/34082">Respiratory</a> <div class="collapse " id="internal-medicine-immunology----respiratory-10533" > </div> </li> <li> <a href="/therapeutics/internal-medicine-immunology/rheumatology" data-drupal-link-system-path="node/34083">Rheumatology</a> <div class="collapse " id="internal-medicine-immunology-----rheumatology-10534" > </div> </li> <li> <a href="/therapeutics/internal-medicine-immunology/transplant-immunology" data-drupal-link-system-path="node/34091">Transplant Immunology</a> <div class="collapse " id="internal-medicine-immunology------transplant-immunology-10544" > </div> </li> <li> <a href="/therapeutics/internal-medicine-and-immunology/urology" data-drupal-link-system-path="node/34084">Urology</a> <div class="collapse " id="internal-medicine-immunology-------urology-10535" > </div> </li> </ul> </div> </li> <li> <a href="/therapeutics/medical-device" data-drupal-link-system-path="node/34085">Medical Device</a> <div class="collapse " id="medical-device-10536" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#oncology-10537"></span> <a href="/therapeutics/oncology" data-drupal-link-system-path="node/34088">Oncology</a> <div class="collapse " id="oncology-10537" > <ul class="menu menu-level-1"> <li> <a href="/therapeutics/oncology/early-phase-oncology" data-drupal-link-system-path="node/34086">Early Phase Oncology</a> <div class="collapse " id="oncology-early-phase-oncology-10538" > </div> </li> <li> <a href="/therapeutics/oncology/immuno-oncology" data-drupal-link-system-path="node/34087">Immuno-Oncology</a> <div class="collapse " id="oncology--immuno-oncology-10539" > </div> </li> </ul> </div> </li> <li> <a href="/therapeutics/pediatrics" data-drupal-link-system-path="node/34089">Pediatrics</a> <div class="collapse " id="pediatrics-10540" > </div> </li> <li class="sidebar--submenu"> <span aria-controls="sidebar-content" class="collapsed " data-toggle="collapse" role="button" href="#rare-orphan-diseases-10541"></span> <a href="/therapeutics/rare-orphan-diseases" data-drupal-link-system-path="node/34090">Rare & Orphan Diseases</a> <div class="collapse " id="rare-orphan-diseases-10541" > <ul class="menu menu-level-1"> <li> <a href="/insights/therapeutics/rare-and-orphan-diseases/leveraging-historical-data-for-use-in-rare-disease-trials" data-drupal-link-system-path="node/33707">Leveraging historical data for use in rare 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