A Phase 2 interventional study of AMX0035 and Placebo in Type 1 Diabetes (T1D), Metabolic Diseases and Glucose Metabolism Disorders, sponsored by University of Washington. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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.
This is a randomized, double-blind, parallel-group clinical trial to evaluate 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). Following screening and baseline assessments, eligible participants will be randomized 1:1 to receive either AMX0035 or placebo, with stratification by sex and body mass index (≥30 vs. \<30 kg/m2). Participants will undergo comprehensive metabolic phenotyping at baseline and 24 weeks, including hyperinsulinemic-euglycemic clamp studies, body composition imaging, continuous glucose monitoring, and tissue biopsies (skeletal muscle and adipose) for assessment of mitochondrial function and biological markers. Participants, clinicians administering the intervention, and laboratory personnel analyzing the samples will remain blinded to treatment assignments throughout the study.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be instructed to take one packet of AMX0035 daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \~6 months.
Drug: AMX0035
Participants will be instructed to take one packet of placebo daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \~6 months.
Drug: Placebo
AMX0035 sachets
Placebo sachets
Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp
Evaluate the effect of 24 weeks of AMX0035 versus placebo on whole-body insulin sensitivity in T1D as assessed by gold-standard two-stage hyperinsulinemic-euglycemic clamp. * Two-stage hyperinsulinemic-euglycemic clamp studies will occur at baseline and 24 weeks. * Insulin sensitivity will be quantified using the M-value (glucose infusion rate), normalized to lean body mass measured by dual-energy X-ray absorptiometry (DXA) and insulin concentration.
Time frame: Baseline, 24 weeks
Changes in glycemic control
Glycemic control will be evaluated via continuous glucose monitoring (CGM) and HbA1c.
Time frame: Baseline, 24 weeks
Changes in body composition
Body composition, including total, regional, visceral, and hepatic fat, will be quantified using DXA and multiparametric MRI.
Time frame: Baseline, 24 weeks
Changes in immune and metabolic biomarkers
* Circulating and peripheral blood mononuclear cell (PBMC)-based biomarkers of inflammation and oxidative stress will be measured. * Associations between these biological markers and insulin sensitivity or glycemic metrics will be examined using multivariable models.
Time frame: Baseline, 24 weeks
Changes in mitochondrial function
Skeletal muscle and adipose tissue biopsies will be analyzed for ER stress, inflammation, and insulin signaling. Skeletal muscle tissue will also undergo assessment of mitochondrial function by ex vivo respiration.
Time frame: Baseline, 24 weeks
Establish the safety and tolerability of AMX0035 in adults with T1D
* Adverse events including hypoglycemia, DKA, and changes in hepatic and renal function will be closely monitored throughout the study. * Tolerability will be assessed through participant-reported symptoms, including gastrointestinal side effects and study discontinuations. * An independent Data Safety Monitoring Board (DSMB) will periodically review unblinded safety data and provide guidance.
Time frame: Duration of study
Plan to share: No
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