AMX0035 in adults with Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, parallel-group Phase 2 trial enrolling 60 adults with Type 1 Diabetes. Participants are randomized 1:1 to receive AMX0035 or placebo for 24 weeks, with stratification by sex and BMI. Comprehensive metabolic phenotyping will include hyperinsulinemic-euglycemic clamps, body composition imaging, continuous glucose monitoring, and tissue biopsies to assess mitochondrial function and biological markers. Investigators and participants are blinded to treatment assignments, and the study is conducted at sites in Seattle and Amsterdam with equal enrollment from each site. The trial aims to determine whether AMX0035 can modulate metabolic pathways relevant to insulin sensitivity and mitochondrial function in T1D.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults ≥18 years to \<70 years of age with established T1D (duration ≥1 year)
2. Currently on insulin therapy (multiple daily injections or insulin pump)
3. HbA1c \<9.5%
4. BMI 18.5-40 kg/m2
5. On stable dose of RASB or statin, if indicated
6. Willing and able to comply with all study procedures

Exclusion Criteria:

1. History of pancreatic disease (including pancreatitis) or pancreatic surgery
2. History of cardiovascular disease or stroke within the past 6 months
3. History of heart failure per New York Heart Association criteria
4. History of severe edema or salt restriction requirement
5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids
6. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m²
7. Liver disease (ALT/AST \>3x upper limit of normal \[ULN\]) or severe hepatic impairment (defined as Child-Pugh Class C)
8. Pregnancy, breastfeeding, or planning pregnancy during the study period
9. Known hypersensitivity to study drug components
10. Abnormal baseline ECG
11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)
12. Chronic use of anticoagulants
13. 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
14. Use of substrates of CYP2C9, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein
15. History of severe hypoglycemia requiring assistance within the past 3 months
16. History of diabetic ketoacidosis (DKA) within the past 3 months
17. Personal or family history of breast cancer or ovarian cancer
18. Current participation in another clinical trial
19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate

Where it's running

• University of Washington Medicine Diabetes Institute (UWMDI)
  Seattle, Washington, United States Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Petter M Bjornstad, MD — University of Washington
• Study coordinator: Amanda Bard, MMS, MS, CCRC
• Email: abard@uw.edu
• Phone: 206-685-2069

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.