Trial results for an open-label, single-arm pilot study (NCT05788965) investigating semaglutide as an add-on therapy for overweight/obese adult patients with cystic fibrosis-related diabetes (CFRD) were posted on ClinicalTrials.gov on 2026-01-21. The study, which enrolled 8 participants, showed a mean body weight reduction of -4.6 kilograms in patients receiving semaglutide treatment.
Background
Semaglutide is being investigated as an add-on therapy to insulin for overweight or obese adult patients diagnosed with cystic fibrosis-related diabetes (CFRD). This pilot study aimed to examine its safety and tolerability in this specific patient population.
Trial design
The study (NCT05788965) was a Phase 2/Phase 3, open-label, single-arm pilot study that enrolled 8 adult participants. The trial investigated semaglutide in patients with Cystic Fibrosis and Cystic Fibrosis-related Diabetes (CFRD). The study evaluated semaglutide as an add-on therapy to insulin for overweight or obese patients.
Key results
The pilot study reported several key measurements for participants receiving semaglutide treatment:
- For "Weight", the mean change was -4.6 kilograms (Standard Deviation: 1.9).
- For "BMI (kg/m2)", the mean change was -1.8 kg/m2 (Standard Deviation: 0.9).
- For "CGM % Time in Target (TIR)", the mean change was an increase of 7 percentage time in target (Standard Deviation: 10.5).
- For "A1c", the mean change was -0.3 change in the percent of HbA1c (Standard Deviation: 0.3).
What this means
The results from this pilot study suggest that semaglutide, when used as an add-on therapy to insulin in overweight or obese adults with CFRD, may lead to reductions in body weight, BMI, and A1c levels, alongside an increase in the percentage of time spent within the target glucose range. While these findings are from a small, open-label study, they provide initial insights into the potential benefits of semaglutide in managing metabolic parameters in this specific patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05788965, titled "Semaglutide in CFRD," were posted on 2026-01-21 on clinicaltrials.gov.