drugset / Trial / NCT07683026
Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo
Phase 2
Not yet recruiting
255 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
RandomizedParallel-groupTriple-blindPrevention
Summary
The goal of this clinical trial is to learn if golimumab is effective at preventing progression to Stage 2 diabetes in participants with presymptomatic Type 1 Diabetes. The expected duration of this study is approximately 6 years. Participants will: * Take golimumab or placebo injections monthly for the duration of the study or until they are diagnosed with either stage 2 or stage 3 Type 1 Diabetes * Visit a study clinic every 6 months for Oral Glucose Tolerance Tests (OGTTs) and other tests until the end of the study
Timeline
- Start
- 2026-08-08
- Primary completion
- 2032-09-01
- Completion
- 2032-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 100 mg | Subcutaneous |