[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054307":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":76,"collaborators":79,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Washington","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AMX0035","EXPERIMENTAL","Participants will be instructed to take one packet of AMX0035 daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \\~6 months.",[13],"Drug: AMX0035",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will be instructed to take one packet of placebo daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \\~6 months.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AMX0035 sachets",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo sachets",[15],[30],{"name":31,"affiliation":5,"role":32},"Petter M Bjornstad, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Amanda Bard, MMS, MS, CCRC","CONTACT","206-685-2069","abard@uw.edu",[40,58],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Washington Medicine Diabetes Institute (UWMDI)","RECRUITING","Seattle","Washington","98109","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-122.33207,47.60621,{"lat":52,"lon":51},[55,56],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":57,"role":32,"phone":25,"phoneExt":25,"email":25},"Petter Bjornstad, MD",{"facility":59,"status":60,"city":61,"state":25,"zip":25,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Amsterdam UMC","NOT_YET_RECRUITING","Amsterdam","Netherlands","NL",{"type":49,"coordinates":65},[66,67],4.88969,52.37403,{"lat":67,"lon":66},[70,74],{"name":71,"role":36,"phone":72,"phoneExt":25,"email":73},"Hayo Osmani","316 50 01 86 08","h.o.osmani@amsterdamumc.nl",{"name":75,"role":32,"phone":25,"phoneExt":25,"email":25},"Daniël van Raalte, MD, PhD",{"type":32,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Petter Bjornstad","Professor: Division of Metabolism, Endocrinology, and Nutrition",[80],{"name":81,"class":6},"Breakthrough T1D","100054307","phase-2-metabolic-modulation-to-enhance-insulin-sensitivity-and-mitochondrial-function-in-type-1-diabetes-metmod-t1d-100054307",false,"NCT07699380","METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)","MetMod-T1D","Inclusion Criteria:\n\n1. Adults ≥18 years to \\\u003C70 years of age with established T1D (duration ≥1 year)\n2. Currently on insulin therapy (multiple daily injections or insulin pump)\n3. HbA1c \\\u003C9.5%\n4. BMI 18.5-40 kg\u002Fm2\n5. On stable dose of RASB or statin, if indicated\n6. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. History of pancreatic disease (including pancreatitis) or pancreatic surgery\n2. History of cardiovascular disease or stroke within the past 6 months\n3. History of heart failure per New York Heart Association criteria\n4. History of severe edema or salt restriction requirement\n5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids\n6. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²\n7. Liver disease (ALT\u002FAST \\>3x upper limit of normal \\[ULN\\])\n8. Pregnancy, breastfeeding, or planning pregnancy during the study period\n9. Known hypersensitivity to study drug components\n10. Abnormal baseline ECG\n11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)\n12. Chronic use of anticoagulants\n13. 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\n14. Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein\n15. History of severe hypoglycemia requiring assistance within the past 3 months\n16. History of diabetic ketoacidosis (DKA) within the past 3 months\n17. Personal or family history of breast cancer or ovarian cancer\n18. Current participation in another clinical trial\n19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate","ALL","18 Years","69 Years",{"count":93,"type":94},60,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","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\u002FDiabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.",[100,101,102,103,104,105,106,107,108],"Type 1 Diabetes (T1D)","Metabolic Diseases","Glucose Metabolism Disorders","Endocrine System Diseases","Autoimmune Diseases","Immune System Diseases","Diabetes Melletus, Type 1","Nutritional and Metabolic Diseases","Combination Therapy","2026-07-09",{"date":111,"type":112},"2026-07-13","ACTUAL",{"date":114,"type":94},"2026-06",{"date":116,"type":94},"2029-12",{"name":5,"class":6},2]