Discussion
weight loss, overweight or obesity
EVENTS, SEVERE OBESITY
Although metabolic surgery remains the most effective and durable therapy for severe obesity and associated comorbidities, 1 in 4 patients experience poor weight loss outcomes. Thus, treatment of these patients remains a clinical challenge with a paucity of randomized clinical trials.To our knowledge, the BARI-OPTIMISE trial is the first randomized clinical trial to evaluate the efficacy and safety of liraglutide, 3.0 mg, compared to placebo as an adjunct to a lifestyle intervention in people with suboptimal weight loss after metabolic surgery. Our findings show that liraglutide, 3.0 mg, for 24 weeks led to a significantly greater reduction in percentage body weight compared to placebo, coupled with reduced fat mass, favorable changes in cardiometabolic risk factors, and improvement in health-related quality of life. At the end of the 24-week treatment period, 71.9% of participants treated with liraglutide, 3.0 mg, compared with 8.8% in the placebo group lost 5% or more of their baseline body weight, a widely used criterion to determine a clinically meaningful response.The estimated treatment difference of −8.03% (95% CI, −10.39 to −5.66) compared to placebo reflects greater weight loss compared to corresponding trials of liraglutide, 3.0 mg, in people with overweight or obesity who have not undergone metabolic surgery.In the BARI-OPTIMISE trial, a mean (SD) percentage weight change of −0.54 (3.32) was seen in the placebo group. This represents comparatively lower weight loss than placebo groups receiving lifestyle interventions in weight management trials.Compared to trials of liraglutide, 3.0 mg, for people with overweight or obesity who have not undergone bariatric surgery, patients in our cohort reported fewer gastrointestinal events, and all participants were able to escalate to the full 3.0-mg dose, suggesting liraglutide, 3.0 mg, was better tolerated in this patient population.Our results show greater absolute weight loss, with an adjusted treatment effect difference of −9.2 kg (95% CI, −11.5 to −6.9), compared to the GRAVITAS randomized clinical trial