drugset / Trial / NCT06050577

The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial

NCT06050577

Phase 2 Active not recruiting 64 enrolled Odense University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The hypothesis for this study is that oral Semaglutide, a GLP-1Ra, has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 50-85 years with type 2 diabetes and an increased risk of bone fractures. Treatment involves once daily oral GLP-1Ra semaglutide or matching placebo for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue and bone marrow tests (bone marrow aspiration and biopsy), physical activity assessed by a questionnaire, and direct bone strength measured by microindentation at the start and end of the study.

Timeline

Start
2024-06-07
Primary completion
2026-01-15
Completion
2027-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Semaglutide Peptide 7 mg Oral
Subject Semaglutide Peptide 14 mg Oral