Obesity is recognized as a global health crisis, with projections showing over a billion adults living with obesity by 2030 and more than half the world’s population overweight or obese by 2035. This epidemic brings not only a staggering human toll but also a projected $4 trillion annual economic impact by 2035. In response, the pharmaceutical industry is experiencing an unprecedented surge in anti-obesity drug development, with over 120 drugs in active development and clinical trials nearly doubling in the last five years.

The New Era of Obesity Clinical Trials

The anti-obesity drug market is evolving at breakneck speed. As highly effective therapies such as GLP-1 receptor agonists both with and without GIP receptor agonists (e.g., tirzepatide, semaglutide) have become household names, patient and clinician expectations have changed. Yet, as the field matures, sponsors face new challenges: such as optimal maintenance of long-term weight loss and addressing lean mass preservation, all while meeting regulatory expectations for safety, diversity, and real-world relevance.

Key Trends Shaping Obesity R&D

1. Innovative Trial Designs:
   Sponsors are adopting basket trials and master protocols to efficiently evaluate therapies across multiple obesity-related indications and comorbidities. For example, the TRIUMPH-1 Phase III study uses a master protocol to assess retatrutide’s impact on weight loss and weight-related conditions like osteoarthritis and sleep apnea, streamlining data collection and regulatory submissions.
2. Long-Term Weight Maintenance:
   The focus still remains on sustainable, long-term outcomes, with healthcare providers and patients driving further conversation on how this can be accomplished. Traditionally, trials have often included lifestyle education, counseling, and support to address the complex behavioral aspects of obesity, but now, flexible dosing regimens, randomized withdrawal designs, and maintenance studies are being further explored to optimize adherence and minimize weight regain.
3. Patient-Centricity:
   Patient insights are shaping trial design more than ever. Sponsors are listening to patient concerns about stigma, side effects, and access, and are integrating tailored communications, emotional support, and supplemental services (e.g., dietitian referrals, fitness plans) to improve recruitment and retention. Regulatory agencies are also pushing for greater diversity in trial populations, ensuring studies reflect real-world demographics and disease prevalence.
4. Holistic Health Outcomes:
   Beyond weight loss, trials are increasingly measuring functional health, quality of life, and the impact on comorbidities such as diabetes, cardiovascular disease, and MASH. The FDA’s latest guidance encourages the use of endpoints that reflect how patients feel, function, and survive, not only changes in BMI.

IQVIA: A Partner for Success in Obesity Drug Development

In this dynamic landscape, IQVIA stands out as a strategic partner for sponsors seeking to navigate complexity and accelerate innovation.

Deep Therapeutic and Operational Expertise

IQVIA’s Obesity Center of Excellence brings together global experts in endocrinology, diabetes, cardiovascular, and metabolic health and regulatory strategy. The team has supported the development and access strategies for the majority of GLP-1 weight management treatments currently approved and has led more than 120 obesity clinical trials across 56 countries.

Patient-Centered Trial Design

IQVIA’s approach starts with the patient. By leveraging real-world insights, patient advocacy input, and behavioral science, IQVIA helps sponsors design trials that address the unique needs and challenges of people living with obesity. This includes:

• Tailored communications and support to address stigma, emotional health, and practical barriers
• Integration of lifestyle interventions and counseling into trial protocols
• Flexible trial designs that improve recruitment, retention, and adherence

Innovative Science and Technology

IQVIA is at the forefront of deploying advanced analytics, digital tools, and global site network to enable efficient data collection, diverse enrollment, and high-quality execution—even in complex, multi-country studies.

Regulatory and Market Access Leadership

IQVIA’s regulatory experts help sponsors navigate evolving guidance, optimize endpoint selection, and build robust evidence packages for approval and reimbursement. The team’s experience with real-world evidence, health economics, and payer engagement ensures that new therapies are positioned for long-term success in a competitive market.

Looking Ahead: The Future of Obesity Trials

As the obesity R&D landscape continues to evolve, sponsors will need to remain agile, patient-focused, and scientifically rigorous. The future will bring more personalized therapies, holistic health outcomes, and innovative approaches to trial design and execution. IQVIA is uniquely positioned to help sponsors seize these opportunities, overcome challenges, and deliver transformative therapies to patients worldwide.

To learn more about strategies for differentiating in a crowded obesity market, download our insight brief.