Case Study

OBESITY: IMAGING IN DRUG DEVELOPMENT TO TREAT METABOLIC

OBESITY: IMAGING IN DRUG DEVELOPMENT TO TREAT METABOLIC

Pages 2 Pages

BACKGROUND Company: Mid-sized pharmaceutical company Therapeutic area: Metabolic Disease Indication: Obesity Phase: III and IV (Post-market) CHALLENGE The sponsor was involved in a large set of clinical studies focusing on a new therapy to treat obesity. Obesity is a growing health issue that significantly increases the risk in patients for developing numerous life-threatening morbidities, including heart disease, stroke, type 2 diabetes, hypertension, and a number of cancers. The sponsor required a uniquely experienced imaging partner to help monitor the safety of their compound being studied at 250 study sites spanning the U.S and Canada. Due to the recent history of other obesity treatment compounds (e.g., fen-phen) causing harm to the heart, both the FDA and the sponsor required

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