NCT07699380RecruitingPhase 2

METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 23 Jun 2026
Start date: Sept 2026
Primary completion date: Dec 2029
Lead sponsor: University of Washington
Diseases: Type 1 diabetes
NCT number: NCT07699380

What you commit to

Study type: Interventional · Phase 2
Planned participants: 60
From Sept 2026 to the primary completion date, Dec 2029
2 sites in 2 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)
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

Other illness

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
Known hypersensitivity to study drug components
Use of substrates of CYP2C9, 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
Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate

Lab values

Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m²
Liver disease (ALT/AST \>3x upper limit of normal \[ULN\]) or severe hepatic impairment (defined as Child-Pugh Class C)

Other

Pregnancy, breastfeeding, or planning pregnancy during the study period
Abnormal baseline ECG
Chronic use of anticoagulants
Current participation in another clinical trial

Who the study is looking for

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

Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Amsterdam UMC Coordinator of this site? Confirm its status	Amsterdam	Netherlands	Not yet recruiting
University of Washington Medicine Diabetes Institute (UWMDI) Coordinator of this site? Confirm its status	Seattle	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.