Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial (OBES1TY)

NCT06909006 Phase 3 NOT_YET_RECRUITING

The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.

Details

Lead sponsor	Nordsjaellands Hospital
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	122
Start date	2025-10
Completion	2028-06

Conditions

• Obesity in Diabetes
• Obesity/Therapy
• Type 1 Diabetes Mellitus (T1DM)
• Insulin Sensitivity/Resistance
• Semaglutide
• Lipidomics
• Metabolomics
• Weight Loss
• Glycemic Control for Diabetes Mellitus

Interventions

• Semaglutide 2.4mg
• Semaglutide placebo

Primary outcomes

• Body weight — 74 weeks
  Body weight will be measured both prior to and following treatment for 68 weeks with either semaglutide or placebo. Changes in body weight will be compared for the two intervention arms, before, throughout and at the end of treatment and then at followup 6 weeks later.

Countries

Denmark