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It will still have to go through Phase 3 clinical trials before FDA approval

Uhl P, Bajraktari-Sylejmani G, Witzigmann D, Bay C, Zimmermann S, Burhenne J, et al

doi: 10.1007/s00125-013-2885-1
doi: 10.1016/j.trsl.2020.07.008

Its been consistent, real results. Average weight loss in 1 year is 11-20% (vs ~2-3% with diet and exercise alone)

Hazard ratios (HRs) with 95% confidence intervals (CIs) were used to assess primary (MACE) and secondary outcomes (all-cause mortality, CV death, non-fatal MI, non-fatal stroke, and HF hospitalisation) between the two treatment groups
