 Statistical Analysis. The planned sample size of 136 participants, with a 1:1 randomization ratio, assumes a 20 drop-out rate at month 12 and was estimated to be adequate to evaluate the primary endpoint with power 90 P0.05, two-sided test. The investigators predict a difference in weight change between the two groups from randomization to month 12 of 4 kg SD3.5. Pre-specified data analysis will be performed on the full analysis set, comprising all randomized individuals exposed to trial drug with at least one post-randomization weight assessment. 