Xtalks — The Life Science Community™, Online webinar
2026-11-06
Paediatric and adolescent obesity trials are now an established part of drug development, but major evidence gaps remain when translating findings across age groups. Regulatory architecture, including FDA draft guidance and ICH E11(R1), does not resolve how trial findings should be interpreted in a growing child. SCALE Teens and STEP TEENS demonstrate that GLP-1 receptor agonists improve BMI-based outcomes in adolescents, but evidence in children aged 6 to 11 remains sparse. Questions also remain around endpoint selection, body composition interpretation under active bone accrual and puberty, biomarker qualification, family-level attribution and participant retention. This webinar explores these challenges through a graded evidence framework for obesity trials, helping sponsors distinguish established approaches from limited evidence and unresolved questions when designing global paediatric programmes. The featured panelists will discuss practical considerations across trial design, patient experience, biomarker strategy and multi-region regulatory planning. The session will examine trial design and regulatory strategy for paediatric cohorts divided by age band, alongside validated, age-appropriate patient-reported outcome (PRO) instruments, cross-cultural adaptation and engagement approaches intended to address discontinuation risk in adolescent pharmacotherapy trials. It will also explore paediatric biomarkers and bioanalytical strategies, including how exploratory markers of metabolic dysfunction may be positioned for eventual regulatory acceptance without overstating the available evidence. Rather than presenting a settled template, the session works from a graded framework: what is supported well enough to design, what rests only on limited teaching cases and what remains genuinely open, giving sponsors a practical, evidence-based framework for developing global paediatric obesity programmes. Register for this webinar to learn how evidence-based endpoint, biomarker, retention and regulatory strategies can strengthen obesity trials in paediatric populations.
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Invited Speakers:
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Graham C Ellis, MD, Clinical Vice President, Signant Health Justin Devine, Co-Founder & Chief Innovation Officer, Synexa Life Sciences Shipra Patel, Global TA Section Head Endocrinology/Metabolism, Global Head of Pediatrics, Parexel
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