Metabolic challenges at CHDR
The early phase development of drugs has entered a new era that requires more efficient study designs and rational choice of biomarkers. Estimation of therapeutic efficacy of new metabolic drugs during early human drug development is challenging and often only possible in phase II of drug development, when the drug is administered for the first time to the relevant patient population. Assessment of potential therapeutic efficacy at earlier stages greatly stimulates and facilitates a more rational development of new metabolic compounds.
Implementation of these ‘metabolic challenges’ in a compound’s clinical development program allows efficient bridging between preclinical experiments and early clinical development stages, including the first administration to the relevant patient population.
Over the last 20 years, CHDR has successfully validated and applied multiple metabolic challenges in clinical studies, varying from relatively easy oral challenges to complex hormone clamp studies.
Assessment of intervention effect
CHDR has experience with several metabolic interventions, including:
- Meal replacement therapies
- Glucagon receptor inhibitors
- Glucose transporter modulators
Characterisation of populations
CHDR has performed several studies to characterise different populations. Some examples are:
- The glucagon challenge response of type 2 diabetes mellitus patients on insulin therapy versus oral antidiabetic treatment
- The oral glucose tolerance test response in healthy volunteers versus type 2 diabetes mellitus patients
- The effects of a high-fat challenge in healthy versus diabetic subjects