[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-alcohol-associated-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-alcohol-associated-liver-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100596542","phase-2-tirzepatide-in-metald-100596542",false,"NCT07046819","Tirzepatide in MetALD","A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Phase 2 Study of Efficacy and Safety of Tirzepatide in Individuals With Alcohol Use Disorder and Metabolic Alcohol-associated Liver Disease","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 21 or older\n2. Ability to provide written informed consent\n3. Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives and an additional barrier method of contraceptive such as condoms; use of an approved IUD or other longacting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s)\n4. Males: Agree to abstain or use accepted form of contraception, such as condoms.\n5. Diagnosis of AUD as confirmed by MINI\n6. Current alcohol use as assessed via the TLFB (\\>14 standard drinks per week for males and \\>7 standard drinks per week for females on average for the last 8 weeks)\n7. Liver steatosis as determined by Fibroscan (CAP score \\>240) at screening\n8. BMI \\>= 25 and \\\u003C40 kg\u002Fm\\^2\n9. metALD as defined by at least one out of 5 criteria at screening:\n\n   1. BMI \\>= 25 and \\\u003C40 kg\u002Fm\\^2\n   2. Fasting serum glucose \\>= 5.6mmol\u002FL \\[100mg\u002FdL\\] or HbA1c \\>=5.7%\n   3. Blood pressure \\>=130\u002F85 or specific antihypertensive drug treatment\n   4. Plasma triglycerides \\>=1.70mmol\u002FL \\[150mg\u002FdL\\] or lipid lowering treatment\n   5. Plasma HDL-cholesterol less than 1.0mmol\u002FL \\[40mg\u002FdL\\] or lipid lowering treatment\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Treatment seeking for alcohol use disorder\n2. History of a serious hypersensitivity reaction to GLP-1RA\u002FGIPRA\n3. Current\u002Fpast use of GLP-1RA\u002FGIPRA within the last 3 months\n4. Clinically significant and\u002For unstable cardiovascular disease over the past 12 months\n5. History of diabetes mellitus or blood hemoglobin A1c (HbA1c) \\>= 6.5 % at screening\n6. Any underlying clinically significant and\u002For unstable acute or chronic liver disease unrelated to alcohol use at screening, history of cirrhosis, esophageal varices\n7. Subjects with platelets count of less than 110,000\u002F mm\\^3\n8. Alanine aminotransferase or aspartate aminotransferase exceeding 5 times the upper limit of normal levels at screening\n9. Bilirubin 2x UNL or Creatinine \\> 2 mg\u002FdL at screening\n10. Patients with coagulopathy defined as INR \\>1.5, prothrombin time prolonged by \\> 3s, and\u002For platelets \\\u003C75,000 \u002F mm\\^3 at screening\n11. Positive HIV test or positive Hepatitis B surface antigen (HBsAg), and\u002For positive Hepatitis C antibody (HCV) at screening\n12. Chronic renal failure as estimated by glomerular filtration rate (GFR) \\\u003C 60mL\u002Fmin\u002F1.73 m\\^2 at screening\n13. History of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n14. History of previous bariatric surgery or transplant surgery\n15. Patients with significant hematologic abnormalities, as defined by hemoglobin \\\u003C 8g\u002FdL and\u002For white blood count \\\u003C1500 cells\u002FmicroL\n16. Current or prior history of any clinically significant disease, including, seizure disorder, epilepsy, alcohol related seizures within 12 months of screening, uncontrolled endocrine disease, hemorrhagic stroke, cancer within the past 5 years or any other significant abnormality identified at the time of screening that, in the judgment of the investigator or study clinician, would preclude safe completion of the study\n17. Use of any medications that interfere with tirzepatide\n18. Use of the following medications with glucose lowering properties in the last 30 days: GLP-1RA, GLP-1RA\u002FGIPRA, insulin, metformin, sulfonylurea, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors\n19. Use of the following medications: Any medication that requires intramuscular administration injections. Systemic corticosteroids\n20. Use of any investigational drugs within 1 month, or five half-lives, whichever is longer, of the study procedures\n21. Presence of any current suicidality or a lifetime history of suicide attempt or suicidal ideation within the past year\n22. History of serious mental illnesses including psychotic disorders, bipolar disorders, severe anxiety, mood, or trauma-related disorders and other psychiatric conditions which in the opinion of the investigators would impede the patient's participation or compliance in the study\n23. History of liver decompensation events such as hepatic encephalopathy or ascites\n24. History of severe gastroparesis\n25. History of pancreatitis in the last 5 years or if subject has chronic pancreatitis\n\nFor optional MRI: a) Presence of ferromagnetic objects in the body that may be adversely affected by or contraindicated for MRI, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report b) Use of MRI- incompatible intrauterine device (IUD).\n\nIndividuals who are pregnant or breastfeeding, or with severe hepatic or renal liver impairment will be excluded from this study because there is no clinical data on the safety of tirzepatide in these populations, including the impact on the fetus or infant. To assess pregnancy status, participants who can become pregnant will be required to take a urine pregnancy test and to test negative before administering study drug.","ALL","21 Years","100 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nPeople with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake.\n\nObjective:\n\nTo test Tirzepatide in people with AUD and MetALD.\n\nEligibility:\n\nPeople aged 21 years and older with AUD and MetALD.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a Fibroscan: This test uses ultrasound to measure how stiff the liver is. They will answer questions about their alcohol drinking, eating habits, and mental health. Participants may opt to have imaging scans of their brain and liver.\n\nThese tests will be repeated in a baseline visit. This visit will take up to 6 hours.\n\nTirzepatide is injected under the skin once a week for 12 weeks. Participants will visit the clinic to receive each injection. Some participants will get a placebo. A placebo is given just like a Tirzepatide injection but contains no medicine. The physical exam and other tests will be repeated during clinic visits. The Fibroscan will be repeated every 2 weeks during the study. Each weekly visit will take up to 3 hours.\n\nAll tests will be repeated on the last visit. These tests will include the imaging scans and Fibroscan. Participants will learn about treatment options for AUD; they will be given recommendations on ways to reduce alcohol intake. This visit will take up to 6 hours.",[27,28],"Metabolic Alcohol-associated Liver Disease","Alcohol Use Disorder",[30,31,32,33],"BMI","Weight","Alcohol","Metabolism","RECRUITING","2026-06-13",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":38},"2026-06-11",{"date":42,"type":21},"2026-07-30",{"name":44,"class":45},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH"]