NCT05537233

ADJUnct Semaglutide Treatment in Type 1 Diabetes

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Viral N. Shah · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.

Conditions

• Type 1 Diabetes
• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide up to 1 mg per week in addition to standard closed-loop therapy
DRUG	Placebo	Injection placebo up to 1 mg per week in addition to standard closed-loop therapy

Timeline

• Start date: 2023-04-11
• Primary completion: 2024-08-06
• Completion: 2024-08-06
• First posted: 2022-09-13
• Last updated: 2025-09-03
• Results posted: 2025-08-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study