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Poster #20 - The Political Economy of GLP-1 Drug Development: Evidence from Global Clinical Trials

Friday, November 6, 5:00 to 6:30pm, Property: Boston Marriott Copley Place, Room: Salon EFG

Abstract

We provide a comprehensive characterization of the global clinical trial landscape for glucagon-like peptide-1 (GLP-1) receptor agonists and incretin-based therapies, with the goal of documenting how the scale, composition, and direction of evidence generation have changed over time. We used the Aggregate Analysis of Clinical Trials.gov database to identify relevant trials and constructed a longitudinal dataset capturing trial start year, phase, sponsor type, indication, status, and therapeutic modality.
We found that the GLP-1 clinical trial ecosystem has expanded dramatically over the past two decades. Annual trial starts increased from fewer than 10 per year in the early 2000s to nearly 200 by 2024-2025, with a temporary contraction in 2020 followed by rapid post-pandemic growth. This distribution indicates both a large accumulated evidence base and a substantial ongoing investment in future indications. We also found a pronounced shift in sponsor composition. Early development was dominated by industry, with near-complete industry control of trial initiation prior to the mid-2000s. Over time, academic and joint academic-industry participation increased, particularly in emerging indications. However, industry has accounted for 60-70% of trials every year since 2020. 
The therapeutic focus of GLP-1 trials has undergone a fundamental transformation. Early trial activity was almost entirely diabetes-dominant, but we found a steady decline in the diabetes share beginning in the 2010s, and by the mid-2020s obesity trials exceed diabetes trials, while trials targeting cardiovascular outcomes, liver disease, and other metabolic conditions constitute a substantial and growing share. We also observe the emergence of smaller but notable trial activity in neurological and behavioral domains, reflecting expansion into exploratory off-label uses. Beyond these core clinical development areas, we also identified the emergence of a long tail of exploratory indications. Trials in neurological conditions, addiction, and other non-metabolic areas appear intermittently beginning in the late 2010s and expand significantly in recent years. Although these categories remain small in absolute terms, their presence signals an expanding evidence frontier in which GLP-1 therapies are being evaluated for multi-system and potentially non-metabolic effects.
In parallel, the modality mix has diversified sharply. While GLP-1 mono-agonist trials remain the largest category, we found rapid growth in dual incretin agonist trials beginning around 2018 and accelerating after 2021, reaching more than 70 trials annually by 2025. Triple agonist trials, while still relatively few, are increasing steadily. This shift reflects a transition from first-generation therapies toward combination incretin strategies aimed at improving efficacy and differentiation.
Taken together, these findings indicate that GLP-1 therapies have transitioned from a disease-specific innovation into a general-purpose metabolic platform, with clinical research activity increasingly organized around broad physiological systems rather than individual diseases. This transformation has important implications for regulatory pathways, evidence generation, pharmaceutical spending, and access to care.

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