Tissue biopsy remains, for some metabolic indications, a relevant outcome measure, e.g. to understand tissue-level PK/PD responses to an intervention. Surrogate endpoints may not be adequate for registration trials or may not provide complete information. In addition, tissue biopsy may allow for assessment of histology, staging of disease, and gene expression, as well as measurement of metabolic processes. It should be noted that for the NASH indication, liver biopsies represent the required regulatory endpoint.
Tissue Biopsy Procedures:
- Adipose tissue biopsies
- Skeletal muscle biopsies
- Liver biopsies for assessment of steatosis, inflammation and fibrosis to determine staging of disease