- Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs, and willing to lose >5% of their body weight. NOTE: Participants may not have documented weight loss greater than 5% of body weight from time of diagnosis. Exceptions that are felt to be due to surgical or other procedures (e.g., mastectomies or reconstruction) may be allowed with prior approval of the Protocol Chair/designee.