Early-Phase Cardiometabolic Development Is Being Rewritten. Are You Ahead of It?

GLP-1s changed everything. Regulatory expectations are rising. Placebo-controlled designs are under ethical pressure. Inside this guide, Prof. Thomas Forst — CMO at hVIVO, 300+ cardiometabolic trials — walks through what that means for your programme.
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Cardiometabolic development looks simple. It’s not.

Every year, promising cardiometabolic programmes stall or fail — not because the science was wrong, but because the trial design couldn’t keep pace with where the field had moved. Getting this right requires more than a CRO. It requires integrated scientific depth, operational precision, and a team that has seen these challenges from every angle. Today’s teams are navigating:

  • Obesity trials where weight loss alone no longer differentiates
  • Diabetes programmes where lowering HbA1c is no longer sufficient
  • MASLD studies where the regulatory path is in flux
  • Renal and hepatic impairment studies that sponsors chronically underestimate
  • Placebo arms that are becoming ethically indefensible in long-term studies
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This guide brings together hVIVO’s cardiometabolic team on the questions that shape earlyphase success

One guide. Eight expert perspectives. The full cardiometabolic picture.

Redesigning Obesity Trials for a Chronic Disease Era

Why BMI isn’t enough, why retention is harder than ever, and how alternative designs are emerging 

GLP-1s and the Future of Metabolic Care

Q&A with Prof. Thomas Forst on ectopic fat, incretin combinations, and what drug developers should know

What 2025 Taught Us About Obesity and the Lab

The shift to precision endpoints, biomarker-driven stratification, and why labs are no longer peripheral

The New Reality of Early-Phase Diabetes Trials

Why lowering glucose is now the baseline, not the goal 

Best Practices in Cardiometabolic Trial Design

Endpoints, recruitment realities, adaptive designs, and assay strategy

Renal and Hepatic Study Challenges

Six misconceptions sponsors have about RI/HI studies, and what the teams running them actually see

Improving Outcomes in Diabetic Kidney Disease

A clinical update on DKD pathophysiology, diagnostics, and the evolving treatment landscape 

Best Practices in Cardiometabolic Trial Design

Endpoints, recruitment realities, adaptive designs, and assay strategy 

Written by the team behind 300+ cardiometabolic trials.

The perspectives in this guide are grounded in decades of hands-on early-phase experience. Professor Thomas Forst — board-certified in internal medicine and endocrinology, former CMO at multiple leading clinical research organisations, and author of over 300 peer-reviewed publications — leads hVIVO’s cardiometabolic programme. hVIVO supports seven of the world’s ten largest biopharmaceutical companies, operating purpose-built early-phase facilities in London and Germany alongside a specialist consulting team.

Thomas Forst
Thomas Forst

Chief Medical Officer

Mannheim Groupes Action & Building 121
Edis Gasanin

Medic

hvivo-Mannheim-Marina-streckebein
Marina Streckebein

Medical Director, Mannheim