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NotablePrimary and study completion pushed from Jul 30, 2026 to Jul 30, 2027v163
MinorRe-verified, no change to tracked fieldsv162
NotableStart date: Apr 1, 2026 to Jun 11, 2026v161
NotableRecruitment opened
Start date changed from estimate of Apr 7, 2026 to Apr 1, 2026
Site details revised
v160
MinorStart date: Apr 6, 2026 to Apr 7, 2026v159
Show 45 earlier versionsHide 45 earlier versions
MinorStart date: Apr 5, 2026 to Apr 6, 2026v158
MinorStart date: Apr 2, 2026 to Apr 5, 2026v157
MinorStart date: Apr 1, 2026 to Apr 2, 2026v156
MinorStart date: Mar 31, 2026 to Apr 1, 2026v155
MinorStart date: Mar 30, 2026 to Mar 31, 2026v154
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MinorStart date: Mar 22, 2026 to Mar 23, 2026v148
MinorStart date: Mar 19, 2026 to Mar 22, 2026v147
MinorStart date: Mar 18, 2026 to Mar 19, 2026v146
MinorStart date: Mar 17, 2026 to Mar 18, 2026v145
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MinorStart date: Mar 9, 2026 to Mar 10, 2026v139
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MinorStart date: Mar 5, 2026 to Mar 8, 2026v137
MinorStart date: Mar 4, 2026 to Mar 5, 2026v136
MinorStart date: Mar 3, 2026 to Mar 4, 2026v135
MinorStart date: Mar 2, 2026 to Mar 3, 2026v134
MinorStart date: Mar 1, 2026 to Mar 2, 2026v133
MinorStart date: Feb 26, 2026 to Mar 1, 2026v132
MinorStart date: Feb 25, 2026 to Feb 26, 2026v131
MinorStart date: Feb 24, 2026 to Feb 25, 2026v130
MinorStart date: Feb 23, 2026 to Feb 24, 2026v129
MinorStart date: Feb 22, 2026 to Feb 23, 2026v128
MinorStart date: Feb 9, 2026 to Feb 22, 2026v127
MinorStart date: Feb 3, 2026 to Feb 9, 2026v126
MinorStart date: Feb 2, 2026 to Feb 3, 2026v125
MinorStart date: Feb 1, 2026 to Feb 2, 2026v124
MinorStart date: Jan 29, 2026 to Feb 1, 2026v123
MinorStart date: Jan 28, 2026 to Jan 29, 2026v122
MinorStart date: Jan 27, 2026 to Jan 28, 2026v121
MinorStart date: Jan 26, 2026 to Jan 27, 2026v120
MinorStart date: Jan 22, 2026 to Jan 26, 2026v119
MinorStart date: Jan 21, 2026 to Jan 22, 2026v118
MinorStart date: Jan 20, 2026 to Jan 21, 2026v117
MinorStart date: Jan 19, 2026 to Jan 20, 2026v116
MinorStart date: Jan 18, 2026 to Jan 19, 2026v115
MinorStart date: Jan 15, 2026 to Jan 18, 2026v114
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
People 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.
Objective:
To test Tirzepatide in people with AUD and MetALD.
Eligibility:
People aged 21 years and older with AUD and MetALD.
Design:
Participants 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.
These tests will be repeated in a baseline visit. This visit will take up to 6 hours.
Tirzepatide 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.
All 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.