NCT07699380 METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
| NCT ID | NCT07699380 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Washington |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-06 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 \[ULN\]) 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 CYP1A2, CYP2C8, CYP2B6, CYP3A4, 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
Contact & Investigator
Petter M Bjornstad, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT07699380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 69 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07699380 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07699380 currently recruiting?
Yes, NCT07699380 is actively recruiting participants. Contact the research team at abard@uw.edu for enrollment information.
Where is the NCT07699380 trial being conducted?
This trial is being conducted at Seattle, United States, Amsterdam, Netherlands.
Who is sponsoring the NCT07699380 clinical trial?
NCT07699380 is sponsored by University of Washington. The principal investigator is Petter M Bjornstad, MD at University of Washington. The trial plans to enroll 60 participants.
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