<<If I'm not mistaken, the regn trial tried to combine lifestyle changes with the phase III. Maybe MZ can confirm or refute this>>
Correct. Protocol for PIII include lifestyle change (regular exercise, non-forced healthy dieting, …), so we may see few more ponds of weight loss in PIII than was observed in short PII (where pts could do whatever they like, and eat as much as they want). For 12 months 5-10% (on average ~240 # it is 12-24 #) weight loss from baseline should be seen as success.
Contrary to what was posted here, I see obesity like any other modern age disease: cardivascular, metabolic, inflammatory,…Combination of the social, environmental and genetic factors. Increase in obesity rate is due to unhealthy eating, lower energy expenditure due to lifestyle and requirements, in part due to many new drugs with weight gaining side effects, genetic makeup and balance,… Anti-obesity drug should be seen as ADD to control and reduce weight in certain period of time, and help to keep weight off for extended period. The bigger problem is not weight loss, it is to keep weight gain off after initial lost is achieved.
Bottom line, obesity is serious problems, and like diabetes may become number one disease in US.
Miljenko
PS: MLNM obesity candidate had wrong positive signal from pre-clinical model, while their obesity (metabolic) program is very active. |