Adults 18 to 65, any sex, with Type 1 Diabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo GroupPrimary· 26 weeks
Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.
Group
Value
95% CI
Semaglutide
13
Control
0
Change in HbA1cSecondary· 26 weeks
HbA1c will be measured at a central laboratory and change in Hba1c from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Group
Value
95% CI
Semaglutide
-0.7
± 0.1
Control
-0.4
± 0.1
Change in Mean GlucoseSecondary· 26 weeks
Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Group
Value
95% CI
Semaglutide
-15.7
± 2.6
Control
-3.6
± 2.8
Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)Secondary· 26 weeks
Percent of time spent in tight glucose range (70-140 mg/dL) will be obtained by CGM and change in percent time in range from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Group
Value
95% CI
Semaglutide
9.8
± 1.7
Control
2.9
± 1.8
Percent Time Spent in CGM-measured Glucose >180 mg/dLSecondary· 26 weeks
Percent of time spent in glucose range \>180 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Group
Value
95% CI
Semaglutide
-11.1
± 1.8
Control
-2.7
± 1.9
Percent Time Spent in CGM-measured Glucose >250mg/dLSecondary· 26 weeks
Percent of time spent in glucose range \>250 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Group
Value
95% CI
Semaglutide
-5.1
± 1.1
Control
-0.5
± 1.2
Percent Time Spent in CGM-measured Glucose <70mg/dLSecondary· 26 weeks
Percent of time spent in glucose range \<70 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Group
Value
95% CI
Semaglutide
0.1
± 0.2
Control
0.4
± 0.2
Change in CGM Measured Glycemic Variability (Coefficient of Variation)Secondary· 26 weeks
Glucose coefficient of variation (mg/dL) will be obtained by CGM and change in glucose CV from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.
Group
Value
95% CI
Semaglutide
-0.3
± 0.8
Control
0.9
± 0.9
Change in WeightSecondary· 26 weeks
The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis.
Group
Value
95% CI
Semaglutide
-9.2
± 0.7
Control
-0.4
± 0.6
Change in BMI (Kg/m2)Secondary· 26 weeks
Change in body mass index (BMI) calculated as kg body weight per meter squared of height from baseline to 26 weeks will be compared by randomization group using an ITT analysis.
Group
Value
95% CI
Semaglutide
-3.3
± 0.3
Control
-0.2
± 0.2
Severe HypoglycemiaSecondary· 26 weeks
SH events in number of patients per group
Group
Value
95% CI
Semaglutide
2
Control
2
Adverse events — posted to ClinicalTrials.gov
Time frame: from signing consent from till end of the study (i.e 26 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT06977438 — Promoting Healthy Children and Youth
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NCT07218354 — Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial
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· not yet recruiting
NCT07511543 — Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy
· Phase 2
· not yet recruiting
NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
· NA
· not yet recruiting
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Other Viral N. Shah trials
Trials by the same sponsor.
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· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Viral N. Shah
Last refreshed: 3 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05537233.