METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Type 1 Diabetes (T1D), Metabolic Diseases, Glucose Metabolism Disorders, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases, Diabetes Melletus, Type 1, Nutritional and Metabolic Diseases, Combination Therapy
In brief
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.
Key facts
- Study ID
- NCT07699380
- Run by
- University of Washington
- People needed
- 60
- Starts
- 2026-06-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Liver disease (ALT/AST >3x upper limit of normal [ULN])
- Pregnancy, breastfeeding, or planning pregnancy during the study period
- Known hypersensitivity to study drug components
- Abnormal baseline ECG
- Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)
- Chronic use of anticoagulants
- Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3
- Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein
- History of severe hypoglycemia requiring assistance within the past 3 months
- History of diabetic ketoacidosis (DKA) within the past 3 months
- Personal or family history of breast cancer or ovarian cancer
- Current participation in another clinical trial
- Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate
Where it is running
- University of Washington Medicine Diabetes Institute (UWMDI) — Seattle, Washington, United States (enrolling)
- Amsterdam UMC — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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