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(jofem.org) The best-case signal: modest weight loss in a shorter trial A frequently cited 12-week randomized trial result (as summarized in reviews) reported: ~2.6 kg average loss with AOD-9604 1 mg/day vs ~0.8 kg with placebo (PMC) This is the kind of result that can be statistically meaningful, clinically modest, and very sensitive to study design (diet, activity, baseline metabolic status, adherence)
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Each year, an estimated 300,000 adults in the United States die of causes related to obesity [2] According to the guidelines of the National Institute of Health (NIH) regarding the treatment of obesity, “weight loss drugs approved by the FDA [US Food and Drug Administration] may only be used as part of a comprehensive weight loss program, including dietary therapy and physical activity, for patients with a BMI [body mass index] of ≥30 with no concomitant obesity-related risk factors or diseases, and for patients with a BMI of ≥27 with concomitant obesity-related risk factors or diseases”[3].The risk factors and diseases considered important enough to warrant pharmacotherapy at a BMI of 27--29.9 are hypertension, dyslipidemia, coronary heart disease (CHD), type 2 diabetes, and sleep apnea [3]
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