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New treatment option for Type 1 Diabetes (T1D)
Official title METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
ClinicalTrials.gov ID: NCT07699380
What this study is testing
What is AMX0035?
AMX0035 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type 1 diabetes (t1d).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States; Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.