CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 115 enrolled
Drug / intervention
Semaglutide +1 moredrug
Likely dose
Semaglutide up to 1 mg once weeklyAI-extracted
Key inclusion· 7
  • ✓Age 18 to 65 years
  • ✓Type 1 diabetes diagnosed for at least 12 months
  • ✓On FDA-approved hybrid closed-loop system for at least 3 months
  • ✓HbA1c between 7.0% and 10.0%
Key exclusion· 19
  • ✕HbA1c ≤7.0% or ≥10.0% at screening
  • ✕Less than 12 months of insulin treatment
  • ✕Use of unapproved insulin formulations for the HCL system (e.g., Fiasp in Tandem Control-IQ)
  • ✕Current use of multiple daily injection or inhaled insulin (Afrezza)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05537233
NCT05537233Phase 2Completed
CompareCT.gov

Efficacy and Safety of Once Weekly Semaglutide in Adults With Obesity and Inadequately Controlled Type 1 Diabetes Using Hybrid Closed-Loop System.

Viral N. Shah·interventional·Posted Sep 13, 2022·Updated Sep 3, 2025

In Brief

A Phase 2 clinical trial evaluating Semaglutide and Placebo for Type 1 Diabetes and Obesity. Completed, enrolled 115 participants across 4 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes, Obesity
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedSep 13, 2022
Enrollment StartApr 11, 2023
Primary CompletionAug 6, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.8 years ago

Interventions

Semaglutidedrug

Semaglutide up to 1 mg per week in addition to standard closed-loop therapy

Placebodrug

Injection placebo up to 1 mg per week in addition to standard closed-loop therapy