Pre-Conference Day

This intensive workshop explores the limitations of monolithic obesity treatments by shifting the focus from simple appetite suppression to the functional genomics and proteomics of energy expenditure. By examining the mechanistic drivers of thermogenesis and the evolving role of the adipocyte, participants will discover how to bypass the limitations of current standards of care and address critical clinical challenges, such as the deterioration of metabolic health and muscle atrophy associated with rapid weight loss.

This session will cover:

• Balancing the Two Levers of Weight Loss & Comparative Bioenergetics: Shifting the therapeutic paradigm from solely restricting energy intake to safely maximizing energy expenditure through novel thermogenic pathways.
• Overcoming the "Lean-Mass Trap" and the Muscle Problem: Addressing the critical challenge of muscle atrophy by prioritizing the preservation and enhancement of lean muscle mass alongside fat-selective reduction.
• Targeting the Adipocyte, Beiging, & UCP1-Independent Thermogenesis: Decoding phenotypic switching and alternative cellular energy expenditure mechanisms beyond traditional UCP1 pathways.
• Leveraging Functional Genomics, Proteomics, & Batokines: Utilizing high-resolution molecular data and batokine biomarker read-outs to identify novel targets, culminating in a Case Study on translating these insights into highly targeted therapeutic assets.

This intensive workshop will delve into the critical shift from traditional BMI-centric metrics to a more sophisticated regulatory framework that reflects the true biological impact of next-generation obesity therapeutics.

As the FDA moves toward evaluating “quality of weight loss” and metabolic improvement, this session provides a strategic toolkit for biotechs to align their clinical endpoints with modern regulatory expectations. Central to this evolution is the Lancet Commission’s new framework, which offers a structured 18-point system to assess tissue and organ dysfunction. By differentiating between Pre-clinical obesity (excess adiposity without dysfunction) and Clinical obesity (impaired organ function), this framework allows for more precise patient stratification and offers a method to prioritize pharmacological or surgical interventions for those with the highest biological risk.

This session will cover:

• Integrating advanced body composition metrics to move beyond the limitations of the scale, utilizing DEXA and MRI data to quantify changes in visceral adipose tissue and lean muscle mass as primary or key secondary endpoints
• Defining meaningful metabolic endpoints by establishing validated links between drug-induced weight loss and the resolution of comorbidities such as MASH, CKD, and heart failure to support “beyond weight loss” label claims
• Designing trials for functional outcomes that measure improvements in physical mobility, exercise capacity, and respiratory function, providing the FDA with clear evidence of enhanced patient quality of life
• Navigating the regulatory path for maintenance and prevention by developing trial structures that satisfy FDA requirements for long-term safety and weight-regain prevention
• Establishing collaborative regulatory strategies for novel mechanisms (such as gene therapies or non-incretins) where traditional weight-loss benchmarks may not fully capture the drug’s therapeutic value