Integrated early-phase strategy across the cardiometabolic continuum LP

Rethinking early-phase cardiometabolic development: from endpoints to execution

The defining problem in early-phase cardiometabolic development is not scientific. It is structural. Clinical pharmacology, biomarker strategy, laboratory analytics, and regulatory thinking advancing in parallel — but not together. The connections that would allow programmes to move with confidence get lost. Data quality suffers. Decisions get made too late.

The science has moved significantly. Obesity trials can no longer be designed around weight loss alone. Early-phase diabetes development now needs to capture cardiovascular, renal, and metabolic signals from the outset. Impaired-population studies need specialist infrastructure and earlier planning than most programmes allow. The bar is higher — and fragmented development cannot clear it.

This eBook, authored by Professor Thomas Forst, Chief Medical Officer at hVIVO, makes the case for integration. Eight expert perspectives across the cardiometabolic continuum — from obesity and diabetes to MASLD and renal/hepatic impairment — on what it takes to generate early-phase evidence that holds up when it matters most.

What’s inside

Why obesity trials must be redesigned for a chronic disease paradigm — what is changing in retention, placebo design, and endpoint selection
What the GLP-1 era has revealed about metabolic disease — and what the next generation of incretin-based therapies must demonstrate to differentiate
How laboratory science is becoming a strategic asset in early-phase cardiometabolic development, not just an operational function
Best practice frameworks for cardiometabolic trial design — endpoints, recruitment, adaptive approaches, and the role of biomarkers
The new reality of early-phase diabetes trials — why HbA1c reduction is now the baseline, not the goal
Why MASLD is one of the most complex areas for early-phase programme design — and what a realistic path forward looks like
The misconceptions that most consistently derail renal and hepatic impairment studies — and what rigorous execution requires
A clinical update on diabetic kidney disease: what the evidence shows and what the emerging treatment options mean for development

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