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Early Phase Metabolic Research with Reference to Special Populations

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Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease

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Abstract

Well-designed and expertly executed early phase clinical trials can provide valuable information that may accelerate ‘go, no go’ decisions, potentially shortening the time of access to new, more efficacious treatments. While first-in-human studies had conventionally been performed in healthy volunteers, more recently there has been acceptance of the use of patients with the disease of interest. In the context of developing new drugs for the treatment of diabetes, obesity, and nonalcoholic steatohepatitis (NASH), this paradigm shift requires consideration of the risks, benefits, and practical challenges of studying patients with obesity, nonalcoholic fatty liver disease (NAFLD), glucose intolerance, type 1 diabetes, and type 2 diabetes. Within these disorders, issues of renal impairment, impaired liver function tests, the metabolic syndrome, and cognitive impairment demand additional consideration. In addition, safe and ethical inclusion of patients with special characteristics, e.g. the pediatric and adolescent age groups, older subjects, and women of childbearing potential, in early phase studies mandates specific risk management strategies. Access to these patient populations and rapid identification of potential volunteers for trials remain critical factors for successful early drug development.

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  1. ProSciento, Inc., Chula Vista, CA, USA

    Linda A. Morrow & Andrew J. Krentz

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  1. Linda A. Morrow
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  2. Andrew J. Krentz
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Correspondence to Linda A. Morrow .

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  1. ProSciento, Chula Vista, CA, USA

    Andrew J. Krentz

  2. ProSciento, Chula Vista, CA, USA

    Christian Weyer

  3. ProSciento, Chula Vista, CA, USA

    Marcus Hompesch

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Morrow, L.A., Krentz, A.J. (2019). Early Phase Metabolic Research with Reference to Special Populations. In: Krentz, A., Weyer, C., Hompesch, M. (eds) Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease. Springer, Cham. https://doi.org/10.1007/978-3-030-11748-1_20

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  • DOI: https://doi.org/10.1007/978-3-030-11748-1_20

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