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.
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
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
University of Washington
Lead sponsor
Breakthrough T1D
Collaborator