drugset / Trial / NCT07699380

METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)

NCT07699380

Phase 2 Recruiting 60 enrolled University of Washington Breakthrough T1D · collab
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

EvaluationDrugModalityDoseRoute
Subject Sodium Phenylbutyrate Small molecule Oral
Subject Taurursodiol Small molecule Oral