Observational studyPloS one2025
An anonymized, de-identified registry study protocol to determine the effectiveness and safety of weight loss with enavogliflozin in patients with type 2 diabetes mellitus.
Observational study in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Sodium-glucose co-transporter 2 inhibitors, such as enavogliflozin, offer promising metabolic benefits for patients with type 2 diabetes (T2D), including glycemic control and improved cardiac function. Despite the clinical evidence, real-world evidence is needed to validate their safety and effectiveness. This study aims to evaluate the effects of weight loss and safety of enavogliflozin administration in patients with T2D in a real-world clinical setting over 24 weeks. This is a large-scale, prospective, multicenter, non-interventional observational study and will be conducted in 12 primary care centers nationwide between 2024 and 2026. Data will be collected at baseline, 12 weeks, and 24 weeks in a real-world clinical setting, including demographic details, clinical history, lifestyle habits, medication use, and various health indicators. Eligible participants are adults aged 19 to 80 with T2D and a body mass index (BMI) of ≥23 kg/m2 who are currently receiving treatment with Envlo (enavogliflozin) or Envlomet (enavogliflozin/metformin) tablets or planning to start treatment. The primary outcome is the change in BMI and body weight at 24 weeks from baseline. Secondary outcomes evaluated are changes in BMI and weight at 12 weeks, the proportion of participants achieving significant reductions in BMI and weight at 12 and 24 weeks, and body composition and glycemic improvements at 12 and 24 weeks. The study will analyze shifts in lipid profiles, liver and kidney functions, and body composition at 12 and 24 weeks as exploratory outcomes. For safety outcomes, the trial will prioritize the monitoring of adverse drug reactions and specific events of interest such as hypoglycemia, urinary tract infections, genital infections, polyuria, and polydipsia. This study design enables us to evaluate the effectiveness and safety of enavogliflozin for weight loss in a real-world setting while exploring its potential positive effects on cardiac function and metabolic risk factors in overweight or obese patients with T2D.
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