Trial results for the study investigating dulaglutide injection for the treatment of Chronic Kidney Diseases were posted on ClinicalTrials.gov on 2025-04-20. The study explored the effects of GLP-1RA on ectopic fat deposition in this patient population. Key findings included a mean change in intermuscular fat deposition of -0.009 fat/muscle ratio in the dulaglutide arm.
Background
Chronic kidney disease (CKD) represents a significant burden of morbidity and mortality. In patients with CKD, increased protein breakdown in skeletal muscle (wasting) and ectopic fat deposition are recognized as important factors contributing to poor clinical outcomes. Insulin resistance plays a critical role in both skeletal muscle wasting and ectopic fat deposition. Glucagon-like peptide-1 receptor agonists (GLP-1RA), such as dulaglutide, have been observed to decrease ectopic fat deposition in patients with type 2 diabetes, prediabetes, and in obese and overweight subjects. The influence of GLP-1RA on ectopic fat deposition specifically in CKD patients was previously unknown, prompting this investigation.
Trial design
The study, identified as NCT05254418, was a Phase 2 trial with an overall status of COMPLETED. It enrolled 7 participants diagnosed with Chronic Kidney Diseases. The intervention involved dulaglutide injection. The study aimed to test the hypothesis regarding the influence of GLP-1RA on ectopic fat deposition in CKD patients. No primary outcomes were explicitly reported for this trial.
Key results
The trial reported several key measurements from the Dulagutide Arm:
- For "Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI)," the mean change was -0.009 fat/muscle ratio, with a Standard Deviation of 0.0526.
- For "Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test," the mean change was 0 score on a scale, with a Standard Deviation of 2.24.
- Regarding "Safety and Feasibility of Dulaglutide Treatment as Evaluated by Subject Interview, Continuous Glucose Monitoring, Adverse Events (AE), Laboratory Tests, Vital Signs, ECG & Allergic/Hypersensitivity Reactions," 2 Participants experienced events.
What this means
The results from this Phase 2 study provide initial insights into the effects of dulaglutide on ectopic fat deposition and physical performance in patients with Chronic Kidney Diseases. The observed mean reduction in intermuscular fat deposition was very small, at -0.009 fat/muscle ratio. Physical performance, as measured by the Systemic Physical Performance Battery Test, showed no mean change. While 2 Participants in the dulaglutide arm experienced adverse events, the small enrollment of 7 participants limits the ability to draw definitive conclusions about the drug's safety profile or efficacy from this study alone. These findings suggest potential avenues for further research into GLP-1RA in CKD, but larger, controlled trials would be necessary to establish clinical significance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05254418, titled "Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease," were posted on 2025-04-20 on clinicaltrials.gov.