Trial results for a study investigating the effectiveness of dapagliflozin for weight loss in patients with pre-diabetes, morbid obesity, or type 2 diabetes were posted on ClinicalTrials.gov on 2025-10-15. The study, which compared dapagliflozin/metformin to metformin alone, showed that the combination therapy was associated with lower mean weights across most measurement points, with a statistically significant difference indicated by a p-value of 0.05 from a Mixed Models Analysis.

Background

The study addressed the high prevalence of obesity in Mexico, reported at 32.4 percent in people over 20 years old, with obesity class III affecting 1.8 percent of males and 4.1 percent of females. Patients in the obesity clinic typically have a mean age of 41 years, with 46 percent having pre-diabetes or type 2 diabetes mellitus (T2D). Current management for glucose metabolism alterations involves dietary treatment and the use of metformin at doses of 1,700 mg/day and/or basal insulin.

Trial design

The study (NCT03968224) was a Phase 2/Phase 3 trial that enrolled 160 participants. It investigated the effectiveness of dapagliflozin for weight loss in individuals diagnosed with PreDiabetes, Obesity, Morbid, and Diabetes Mellitus, Type 2. Participants received either dapagliflozin/metformin combination therapy or metformin alone.

Key results

The trial evaluated "Change in Weight" by reporting mean absolute body weights at several measurement points. For the dapagliflozin/metformin group, mean weights were observed as 121.5 kg (Standard Deviation: 21.1), followed by 118 kg (Standard Deviation: 20.8), 116.3 kg (Standard Deviation: 20.11), 114.4 kg (Standard Deviation: 17.8), 115.4 kg (Standard Deviation: 17.9), and finally 116 kg (Standard Deviation: 19). In comparison, for the metformin alone group, mean weights were initially 125.9 kg (Standard Deviation: 23.9), then 123.7 kg (Standard Deviation: 21.8), 120 kg (Standard Deviation: 20.58), 119.9 kg (Standard Deviation: 22.4), 118.4 kg (Standard Deviation: 21.4), and finally 115 kg (Standard Deviation: 20.18).

A Mixed Models Analysis indicated a statistically significant difference between the groups with a p-value of 0.05.

What this means

The results suggest that the addition of dapagliflozin to metformin therapy may contribute to lower mean body weight in patients with pre-diabetes, morbid obesity, or type 2 diabetes. The statistically significant finding from the Mixed Models Analysis supports an overall difference between the treatment groups. These findings could inform clinical decisions regarding weight management strategies in these populations, particularly where current metformin-based regimens are in place.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03968224, titled "Effectiveness of Dapagliflozin for Weight Loss," were posted on 2025-10-15 on clinicaltrials.gov.