AMX0035 compared with placebo for insulin response in adults with type 1 diabetes
Tests AMX0035 against placebo in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT07699380, who can take part
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Washington
- Trial code
- NCT07699380
- Record updated
- 15 September 2026
- Original 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.Read full original descriptionShow less
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
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.
Inclusion: 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: 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; 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; 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); Pregnancy, breastfeeding, or planning pregnancy during the study period; Abnormal baseline ECG; Chronic use of anticoagulants; Current participation in another clinical trial.