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[5] The core regulatory point is one many patients do not realize: compounded drugs do not go through FDA premarket review for safety, quality, or effectiveness

One phase IIb clinical trial administered setmelanotide to obese participants with heterozygous MC4R deficiency and obese controls over 28 days, observing a placebo-adjusted weight loss of 2.6 kg and 4.0 kg respectively [98]