A Phase 3 clinical trial investigating metformin hydrochloride for the treatment of frailty and sarcopenic obesity in older adults, within the broader therapeutic context of Canagliflozin and related treatments, reached its primary completion on 2025-07-31. This study (NCT04221750) enrolled 114 participants to evaluate a multicomponent intervention aimed at improving health outcomes in this vulnerable population.
Background
The increasing prevalence of obesity in older adults, including many older Veterans, represents a major public health concern. This often leads to conditions such as frailty and sarcopenic obesity, which are characterized by a decline in physical function and muscle mass alongside excess body fat. These conditions significantly impact the quality of life and independence of older individuals. Treatments targeting these complex issues are crucial for improving health in the aging population.
Trial design
The study, officially titled "Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors" (NCT04221750), is a Phase 3, randomized trial. It was designed to investigate the efficacy of a multicomponent intervention. The trial enrolled a total of 114 participants who presented with conditions including frailty, sarcopenic obesity, and general issues related to aging. Participants in the study received interventions of either metformin hydrochloride or a placebo. Both arms of the study were combined with lifestyle therapy, which included diet-induced weight loss and exercise training. The primary objective of the trial was to test the central hypothesis that this combined intervention strategy would be the most effective approach for reversing sarcopenic obesity and frailty in older Veterans with obesity.
Source
The information regarding the primary completion of this clinical trial was sourced from ClinicalTrials.gov, a comprehensive public database of clinical studies. The status for study NCT04221750, titled "Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors," was recorded as completed on 2025-07-31 on clinicaltrials.gov.