NCT07699380 · University of Washington
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
(MetMod-T1D)
What this study is about
The study is a randomly assigned, where neither patients nor doctors know which treatment is given, parallel-group clinical trial to examine the effects of 24 weeks of taken by mouth AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per treatment group$1).
View original scientific description
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.
Interventions
DRUG
AMX0035
AMX0035 sachets
DRUG
Placebo
Placebo sachets
Primary outcome measures
Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp
Time frame: Baseline, 24 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Exclusion criteria
- 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
- Seattle, Washington
Collaborators
Breakthrough T1D
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations