Jim,
Many sources data indicate that in US prevalence of obesity is ~30% (MBI>30, person is ~20% over his ideal weight).
The prevalence of severe obesity (BMI>40, person is 60% overweight) is ~5%, or 15 millions in US.
However, medical obesity (included risk factor, and current environmental and social factors) started at BMI>35, imo. At this point obesity should be seen as serious medical condition and treat adequately. So, my view is that A will target population with BMI>35, or 20-25 millions (or maybe more?).
In PII BMI selection was from 35-50. In PIII is 30-50 for healthy person or 27-55 for those with obesity related risk factors.
In PII on average person lost ~4% of weight (10#), or 25% lost >5% weight. While data are for small pts numbers, it is interesting. Indicate that weight loss is proportional with baseline weight.
Most interesting will be 10% weight loss in PIII. For mean weight ~220-250 # at entry (my estimate) it is ~22-25#. I am hoping that they will have 10-15 percentage points difference than placebo.
<<Also, do you know that genotyping is allowed in this study?>>
Have no idea.
Miljenko |
