ClinicalTrials.gov posted results on 14 September 2026 for a completed Phase 3 trial associated with canagliflozin. The study enrolled 114 participants and evaluated diet and exercise with metformin or placebo for frailty and sarcopenic obesity in older adults with obesity. The largest reported functional difference was a mixed-model mean difference of 2.5 score points, with a 95% confidence interval of 1.2 to 3.8 and p=0.0002.

Background

The trial was titled “Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors.” Its listed conditions were frailty, sarcopenic obesity, and aging. The registry summary described a multicomponent intervention combining lifestyle therapy—diet-induced weight loss and exercise training—with metformin to test whether it could reverse sarcopenic obesity and frailty in older Veterans with obesity. The listed interventions were metformin hydrochloride and placebo. The supplied record does not provide mechanism details, prior approvals, or prevalence figures for canagliflozin or metformin.

Trial design

This completed Phase 3 study, identified as NCT04221750, enrolled 114 participants. Reported groups included Lifestyle Therapy Plus Metformin, Lifestyle Therapy Plus Placebo, and Healthy Lifestyle Plus Metformin. The record contains no primary-outcome entries. Posted measurements covered change in the Modified Physical Performance Test, muscle strength, gait speed, and peak aerobic power.

Key results

For the Modified Physical Performance Test, mean change was 3.8 score points with lifestyle therapy plus metformin, 3.6 score points with lifestyle therapy plus placebo, and 1.2 score points with healthy lifestyle plus metformin; each reported standard error was 0.4 score points.

Muscle-strength change was 11.4 N.m with lifestyle therapy plus metformin and 10.3 N.m with placebo, compared with -0.6 N.m for healthy lifestyle plus metformin. Gait-speed change was 0.12 m/min, 0.13 m/min, and 0.01 m/min, respectively. Peak aerobic power changed by 3.6 ml/kg/min, 3.5 ml/kg/min, and 0.2 ml/kg/min.

The six mixed-model analyses reported mean differences of 2.5, 0.1, 12.2, 1.2, 0.11, and -0.02. Their p-values were 0.0002, 0.92, 0.0002, 0.73, 0.001, and 0.56; corresponding 95% confidence intervals were 1.2 to 3.8, -1.2 to 1.4, 5.8 to 18.5, -5.4 to 7.8, 0.03 to 0.19, and -0.11 to 0.06. The record does not identify which analysis corresponds to each outcome.

What this means

The posted results show improvements across several functional measures in the reported lifestyle-plus-metformin group, but the supplied record does not map the mixed-model analyses to specific outcomes. It also lists no primary outcomes and provides no adverse-event summary. The data therefore support description of the reported measurements, not a definitive conclusion about comparative efficacy or safety.

Source

Source: ClinicalTrials.gov, registry results for the completed Phase 3 study “Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors,” posted 14 September 2026. Available at clinicaltrials.gov/study/NCT04221750.