Among participants who lost at least 5% of their baseline weight during year 1, initial weight loss was greatest in the ILS group (11.0% vs. 8.9% in the metformin group and 9.2% in the placebo group); at year 6 and beyond, the percentage who maintained weight loss greater than 5% was lower in the ILS group (43%) than in the metformin group (56%).
Several limitations have been identified, including the number of participants in the ILS and placebo groups who received metformin increased over time - by year 15, 37% of those in the placebo group had been treated with metformin. Of note, only 72% of participants in the metformin group were adherent (defined as taking ≥80% of the assigned dose).