Early-phase cardiometabolic development: from endpoints to execution
Dear Kenneth,
The defining problem in early-phase cardiometabolic development is not a lack of scientific understanding. It is fragmentation — clinical pharmacology, biomarker science, and regulatory strategy advancing in silos, losing the connections that would allow programmes to move with confidence.
This eBook from Professor Thomas Forst, Chief Medical Officer at hVIVO, shows what integrated early-phase strategy looks like across the full cardiometabolic continuum — and why that integration is what separates programmes that generate decision-ready evidence from those that stall.
Key insights include
- Why placebo-controlled obesity trials are becoming ethically and operationally untenable — and what active comparator and putative placebo designs offer
- How metabolic phenotyping and body composition imaging are redefining what early-phase cardiometabolic studies can and should measure
- Why early-phase diabetes trials must now capture cardiovascular, renal, and hepatic signals — not just glycaemic markers
- What makes MASLD one of the most operationally and diagnostically complex areas for early-phase development
- Why fragmentation costs programmes — and what an integrated specialist ecosystem delivers instead
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