Trial results for semaglutide in the ADJUnct Semaglutide Treatment in Type 1 Diabetes study (NCT05537233) were posted on ClinicalTrials.gov on 2025-08-12. The Phase 2 study investigated semaglutide as an adjunct therapy for inadequately controlled obese adults with Type 1 Diabetes. A key finding showed 13 participants in the semaglutide group achieved a composite outcome of glycemic control and weight reduction, compared to 0 participants in the placebo group.
Background
Semaglutide is a medication investigated for its role in managing metabolic conditions. This study specifically explored its potential as an adjunct treatment for obese adults with Type 1 Diabetes who were already using FDA-approved hybrid closed-loop therapies.
Trial design
The ADJUnct Semaglutide Treatment in Type 1 Diabetes study (NCT05537233) was a Phase 2, completed study that enrolled 115 participants. The trial investigated once-weekly semaglutide injection compared to placebo in inadequately controlled obese adults with Type 1 Diabetes using FDA-approved hybrid closed-loop therapies.
Key results
The trial results demonstrated notable differences between the semaglutide and placebo groups across several glycemic and weight-related outcomes at 26 weeks.
- For the composite outcome, defined as CGM-measured Time in Range (TIR)>70% with Time Below Range (TBR)<4% and a reduction in Body Weight by 5%, 13 participants in the semaglutide group achieved this, compared to 0 participants in the control group.
- The change in HbA1c was -0.7 percentage HbA1c (Standard Error: 0.1) for the semaglutide group, versus -0.4 percentage HbA1c (Standard Error: 0.1) for the control group.
- Mean glucose levels changed by -15.7 mg/dL (Standard Error: 2.6) in the semaglutide group, compared to -3.6 mg/dL (Standard Error: 2.8) in the control group.
- The percent time spent in CGM-measured glucose range of 70-140 mg/dL (Time in Tight Target Range; TTIR) increased by 9.8 percentage of time (Standard Error: 1.7) for semaglutide, versus 2.9 percentage of time (Standard Error: 1.8) for control.
- Percent time spent in CGM-measured glucose >180 mg/dL decreased by -11.1 percentage (Standard Error: 1.8) in the semaglutide group, compared to -2.7 percentage (Standard Error: 1.9) in the control group.
- Percent time spent in CGM-measured glucose >250 mg/dL decreased by -5.1 percentage (Standard Error: 1.1) in the semaglutide group, compared to -0.5 percentage (Standard Error: 1.2) in the control group.
What this means
The findings from this Phase 2 study suggest that semaglutide as an adjunct therapy may offer significant benefits for obese adults with Type 1 Diabetes, particularly in achieving a composite outcome of improved glycemic control and weight reduction. The observed improvements in HbA1c, mean glucose, and time in tight target range, alongside reductions in time spent at high glucose levels, indicate a potential role for semaglutide in this challenging patient population. These results warrant further investigation in larger clinical trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05537233, titled "ADJUnct Semaglutide Treatment in Type 1 Diabetes," were posted on 2025-08-12 on clinicaltrials.gov.