Navigating to 2030: A playbook for differentiating next-generation obesity therapies

This is the introduction to Parexel's "Navigating to 2030" playbook series on differentiating next-generation obesity therapies. This series offers strategic insights across trial design, regulatory considerations, clinical operations, and patient retention strategies to support sponsors in this rapidly evolving and competitive market. To navigate to other sections, click the buttons below.

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By 2050, more than half of adults and a third of children and adolescents worldwide will be overweight or obese.¹ The personal, societal, medical, financial, and mental health burdens of these complex, chronic conditions are multiplying rapidly. Novo Nordisk and Eli Lilly lead the market with their first-generation glucagon-like peptide-1 agonists (GLP-1s), and within the past six months both have launched the first oral GLP-1 pills approved for weight loss, Wegovy (oral semaglutide)² and Foundayo (orforglipron).³ These new entries open the field to broader cash-pay access, simpler global distribution, and a fresh round of competition. Behind them, more than 600 anti-obesity candidates targeting a range of mechanisms and spanning all stages of development (Figure 1) will compete in a global market projected to exceed $100 billion by 2030.⁴

At Parexel, over the past five years, we have completed 22 Phase I to IV obesity and obesity-related clinical trials for sponsors, enrolling 10,000 patients at more than 350 sites. We have conducted an additional 300 projects in other endocrine and cardiometabolic disorders, with a concentration in diabetes. Many biotech companies ask us about strategies for developing second-generation GLP-1s, combination therapies, and next-generation products for obesity and related cardiometabolic diseases, such as metabolic dysfunction-associated steatohepatitis (MASH). They all want to know how to differentiate their drugs in a crowded market.    

In our experience, decision-making must begin with precisely defined market positioning, which in turn determines optimal trial designs and regulatory strategies. Sponsors must then rely on patient insights and operational excellence to enroll and retain eligible patients in clinical studies. 

In this playbook, we present the perspectives of experts and former regulators at Health Advances and Parexel on six of the most critical aspects of developing next-generation products to address the global epidemic of obesity and metabolic diseases:

1. Carving a unique niche in the obesity and cardiometabolic markets
2. Measuring body composition as a proxy for higher-quality weight loss
3. Employing advanced trial strategies to meet stakeholders’ needs 
4. Proactively filling evidence gaps and mitigating regulatory risks 
5. Streamlining operations for rapid and reliable enrollment
6. Engaging and retaining trial participants with targeted strategies

We hope you find this playbook helpful on your journey to commercial success.

Figure 1. Drug pathways for weight loss and the global weight loss pipeline.

Source: Health Advances analysis, Pharmaproject Corporate Press Releases. 
 

Resources

1. Global, regional, and national prevalence of child and adolescent overweight and obesity, 1990–2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021, The Lancet (March 8, 2025).
2. Wegovy® pill approved in the US as first oral GLP-1 for weight management, Novo Nordisk A/S press release (December 22, 2025).
3. FDA approves Lilly’s Foundayo™ (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions, Eli Lilly and Company press release (April 1, 2026).
4. Dozens of new obesity drugs are coming: these are the ones to watch, Nature (February 12, 2025).
    

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