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Designing obesity trials around real lives: How patient centered approaches drive better recruitment and retention

The explosion of interest in anti-obesity therapies, especially GLP-1s, has transformed how patients and others view obesity, shifting the narrative from feelings of personal failure to a chronic, treatable disease. This shift is fuelling unprecedented clinical activity, with more than 124 investigational molecules in development. In turn, competition for clinical trial participants is intensifying, and trial sponsors face heightened expectations to demonstrate therapeutic differentiation and real-world value.

As the field rapidly accelerates, the studies that stand apart will be those that authentically incorporate patient perspectives, empowering participants to act as co-pilots in their healthcare care journey and strengthening recruitment, retention, and evidence quality.

Below, we highlight several of the practical levers sponsors can pull to translate patient-centred principles into action, designing obesity trials that truly reflect and respond to participants’ lived experiences.

Anchor protocol design in the realities of patient experiences

Obesity is a heterogeneous condition that simply does not look, feel or behave the same across individuals. Variables, such as comorbidities, experiences with stigma, emotional factors, and responses to treatment, can collectively shape motivation and adherence.

For one, people living with obesity report a heavy emotional burden, with feelings of shame, loneliness, and anxiety about seeing a healthcare professional, and even discrimination in their workplace. Adding to these emotional influencers, there are also practical roadblocks to trial engagement, like transportation to and from sites, time off from work, and potential for trial burden. When these realities are acknowledged and addressed during protocol design and related patient outreach activities and communication, engagement can improve.

How can this patient-centric protocol be put into practice?

  • Co-create trial protocols with patients for downstream value. This includes integrating patient advisory boards and qualitative patient insights to help reduce amendments and accelerate start up.
  • Prioritise flexibility. For some participants who have felt judged in the healthcare system, it is essential to reduce even small logistical frictions that can affect adherence more than motivation. Offering remote or hybrid site visits, flexible scheduling, travel support, and compassionate, non-stigmatising communication are all core ways to reduce trial burden.
  • Embed respect and bias awareness into site training. Because participants with obesity may experience anxiety when interacting with healthcare teams, site training must go beyond technical requirements to include stigma-free language and bias mitigation.

Viewing engagement as an ecosystem, not a tactic

Patient recruitment and retention improve when support is multidisciplinary, coordinated, and consistent across every touchpoint. In obesity trials, improving chances for trial success comes from creating a motivating engagement ecosystem that blends omnichannel outreach, well-trained site teams, behavioural science informed content, support services, and intuitive digital tools to help patients feel supported and confident in their progress, even through inevitable plateaus.

In a survey of 179 sites across the US and Europe, the most highly rated retention tools included access to RDs, appreciation items, lifestyle resources, local peer support groups, and information on affordable, healthy food sources.

Other notable components of a strong engagement ecosystem include: 

  • Insight driven segmentation: Use primary research and behavioural science to develop nuanced patient personas that reveal what motivates individuals to join a study (e.g., improved health, weight loss, access to care) and what may lead them to disengage (e.g., side effects, slow progress, logistical hurdles). These insights should inform tailored messaging, cadence, and support to meet the needs of each person, not only the protocol.
  • Data informed, omnichannel strategies: Combining targeted digital outreach with healthcare provider referrals and community partnerships helps surface eligible participants, including those managing related conditions, such as type 2 diabetes or cardiovascular disease.
  • Digital tools that meet patients where they are: Tools such as secure in-app messaging, concierge style scheduling, milestone alerts, micro learning modules, and culturally relevant content can meaningfully reduce friction and help sustain momentum throughout the study. Every digital interaction should feel helpful and genuinely worth the participant’s time, especially during periods when motivation naturally dips.

An empathy-first communications playbook

From the first digital impression to the final follow up visit, every touchpoint in obesity trials shapes how participants perceive the study and their place within it. As previously noted, an empathy-first approach requires communication that is plain, non-stigmatising, and transparent about risks, placebo design, timelines, and expected experiences. For example, it is helpful to include visuals that represent varying body sizes, ages, races, etc., to provide an empowering context of where participants may be in their journey.

For underserved patient populations with a higher prevalence for obesity, these tailored materials reflect their lived realities, including cultural contexts, work patterns, caregiving responsibilities, and transportation needs. These details may seem small, but for individuals who have long felt judged, unseen, or dismissed, they signal that the trial is offering something unique and meaningful for them.

As progress rarely moves in a straight line, particularly in weight management efforts, clear expectation setting also plays a critical role. Participants may come into trials with anxiety about the placebo effect, concerns about slow progress or plateaus, or assumptions about therapies. Offering plain language explanations of treatment randomisation, the range of response patterns, possible side effects, and what progress can look like beyond the scale (e.g., improved sleep, mood, mobility, etc.) can help reduce discouragement and potential dropout.

Integrating supportive communication to keep patients engaged through the trial includes:

  • Milestone based coaching by registered dietitians or trained health coaches to offer structured encouragement at key points in the trial journey, such as dose titration periods, early lab visits, or lifestyle goal setting moments.
  • Small recognitions, including appreciation items or digital badges, to reinforce persistence and foster a sense of belonging.
  • Anticipatory guidance and practical tools for managing side effects, helping participants to navigate common issues without feeling dismissed or alarmed.
  • Continuous feedback loops through short surveys or quick check-ins for study teams to better spot emerging challenges (e.g., transportation, scheduling, or unclear instructions) and resolve them in real time.

Equipping sites to deliver with care and quality

Even the most patient-centred protocol can fall short if sites are not fully equipped to deliver the empathy, consistency, and operational ease that obesity trials require. Sponsors and clinical research organisations can play a crucial role in enabling this by accounting for the right resources and providing turnkey materials that sites can deploy quickly, reducing the burden on site staff.

As touched on previously, effective site engagement starts with training that prioritises tone and technique. Staff can focus on language that avoids moralising and reinforces trial participation as a “journey”, not a “struggle”. Training should also cover practical sensitivities, such as ensuring appropriately sized gowns, furniture, and equipment, which contribute to a more comforting participant experience from the moment someone enters the clinic.

Equally important is reducing operational barriers. When sponsors support sites with centralised scheduling tools, templated reminders, reimbursement automation, and other administrative infrastructure, site staff regain time to build the human connection with participants. Streamlining these processes allows coordinators and investigators to focus on the personal interactions that keep people feeling valued and motivated.

Site selection is another critical consideration. Choosing locations with prior obesity trial experience, welcoming clinical environments, and easy access to public transportation or community hubs can significantly influence whether participants may enrol and remain in a trial. The overall “feel” of a site can help mitigate stigma early and set the tone for a supportive trial experience.

It is important for sponsors to note that these needs vary globally. Dietary patterns, access to healthy foods, standard of care, and perceptions of research differ widely by region. For example, participants in the US may arrive with higher awareness of clinical trials and expectations for advanced therapies and digital support, while participants in European countries may require localised messaging, multiple translations, and closer coordination with general practitioners and regional authorities.

Looking ahead: Building emotionally resonant obesity trials

The obesity pipeline is expanding rapidly, and payers are demanding clearer evidence of cost effectiveness. To meet these expectations, sponsors must design trials that not only capture clinical outcomes, but also reflect what matters to patients and what drives real-world use. In today’s landscape, the participant experience has become one of the most strategic differentiators.

A motivating engagement ecosystem is essential to sustain patient interest, but also in delivering operational advantages, such as faster recruitment, stronger data quality, and greater external validity. When patients help shape obesity-focused trials from the start, every interaction becomes more respectful, more motivating, and ultimately more capable of generating meaningful results for the people these therapies aim to serve.

About the authors

Debra Gerlach

Debra Gerlach is an accomplished clinical research leader with over 22 years of industry experience, including 16 years dedicated to global patient recruitment and site engagement. As director of patient recruitment strategy at IQVIA, she leads strategic initiatives across multiple therapeutic areas – including oncology, rare diseases, pediatrics, gastroenterology, infectious disease, and endocrinology (obesity, MASH, T2D) – using innovative approaches, such as decentralised trials, direct outreach, home nursing, and site resourcing. Gerlach has held key roles at leading organisations, including IQVIA, Fortrea, AbbVie, and the University of Pittsburgh Medical Center. She has presented at major industry conferences on patient-centric trial design and recruitment optimisation. She holds a master’s degree in experimental psychology from the University of Hartford and a BA in Psychology from Ohio University.

Stephanie Galarza

Stephanie Galarza is a clinical research leader with over a decade of experience in patient recruitment and trial optimisation. At IQVIA, she leads a team focused on improving patient recruitment and retention strategies, aligning operational execution with strategic goals across global studies. Known for her holistic approach, Galarza integrates data-driven insights with patient-centred practices to enhance engagement and retention throughout the clinical trial journey. Her background includes leadership roles at Clariness and ICON, with expertise in digital recruitment, feasibility, and cross-functional collaboration. She holds a master’s degree in clinical research administration from George Washington University and a BSc in nutrition from NYU.

About IQVIA

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IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI, advanced analytics, the latest technologies and extensive domain expertise. IQVIA is committed to using AI responsibly, with AI-powered capabilities built on best-in-class approaches to privacy, regulatory compliance and patient safety, and delivering AI to the high standards of trust, scalability and precision demanded by the industry. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialisation of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analysing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviours and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

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