NCT07699380
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
Recruiting · Phase 2 · University of Washington · registry updated 2026-09-15
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Adults ≥18 years to \<70 years of age with established T1D (duration ≥1 year)
- Currently on insulin therapy (multiple daily injections or insulin pump)
- HbA1c \<9.5%
- BMI 18.5-40 kg/m2
- On stable dose of RASB or statin, if indicated
- Willing and able to comply with all study procedures
Exclusion
- History of pancreatic disease (including pancreatitis) or pancreatic surgery
- History of cardiovascular disease or stroke within the past 6 months
- History of heart failure per New York Heart Association criteria
- History of severe edema or salt restriction requirement
- Biliary disease or pathologies that may alter enterohepatic circulation of bile acids
- Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m²