drugset / Trial / NCT07699380
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center/Diabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.
Timeline
- Start
- 2026-06
- Primary completion
- 2029-12
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Phenylbutyrate | Small molecule | — | Oral |
| Subject | Taurursodiol | Small molecule | — | Oral |