Metabolic challenges at CHDR
The possibility to assess potential therapeutic efficacy at an early
stage greatly facilitates rational development of new metabolic
compounds. However, estimation of therapeutic efficacy of new metabolic drugs during early clinical drug development is challenging and often only possible in phase 2, when the drug is administered for the first time to the relevant patient population.
In overcoming this challenge, CHDR has successfully validated and applied multiple metabolic challenges in clinical studies, varying from relatively simple oral challenges to complex hormone clamp studies. Implementation of these metabolic challenges in a compound’s clinical development programme enables efficient bridging between preclinical experiments and early clinical development stages, including the first administration to the relevant patient population.
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. Such studies include:
- 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