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Could a diabetes drug curb alcohol cravings and save livers?

NCT ID NCT07046819

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 4 times

Summary

This study tests whether tirzepatide, a drug approved for weight management, can help people with alcohol use disorder and related liver disease drink less and improve liver health. 120 adults will receive weekly injections of tirzepatide or a placebo for 12 weeks. Researchers will measure changes in body weight, liver fat, and drinking behaviors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide (a weight management drug)
What this could lead to
If it works, this could point toward a new treatment that helps people drink less and improves liver health.
What could go wrong
This is an early Phase 2 trial with only 120 people, so results may not apply to everyone. The drug may not reduce alcohol cravings or liver damage more than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age 21 or older 2. Ability to provide written informed consent 3. 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) 4. Males: Agree to abstain or use accepted form of contraception, such as condoms. 5. Diagnosis of AUD as confirmed by MINI 6. 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) 7. Liver steatosis as determined by Fibroscan (CAP score \>240) at screening 8. BMI \>= 25 and \<40 kg/m\^2 9. metALD as defined by at least one out of 5 criteria at screening: 1. BMI \>= 25 and \<40 kg/m\^2 2. Fasting serum glucose \>= 5.6mmol/L \[100mg/dL\] or HbA1c \>=5.7% 3. Blood pressure \>=130/85 or specific antihypertensive drug treatment 4. Plasma triglycerides \>=1.70mmol/L \[150mg/dL\] or lipid lowering treatment 5. Plasma HDL-cholesterol less than 1.0mmol/L \[40mg/dL\] or lipid lowering treatment EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. Treatment seeking for alcohol use disorder 2. History of a serious hypersensitivity reaction to GLP-1RA/GIPRA 3. Current/past use of GLP-1RA/GIPRA within the last 3 months 4. Clinically significant and/or unstable cardiovascular disease over the past 12 months 5. History of diabetes mellitus or blood hemoglobin A1c (HbA1c) \>= 6.5 % at screening 6. Any underlying clinically significant and/or unstable acute or chronic liver disease unrelated to alcohol use at screening, history of cirrhosis, esophageal varices 7. Subjects with platelets count of less than 110,000/ mm\^3 8. Alanine aminotransferase or aspartate aminotransferase exceeding 5 times the upper limit of normal levels at screening 9. Bilirubin 2x UNL or Creatinine \> 2 mg/dL at screening 10. Patients with coagulopathy defined as INR \>1.5, prothrombin time prolonged by \> 3s, and/or platelets \<75,000 / mm\^3 at screening 11. Positive HIV test or positive Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV) at screening 12. Chronic renal failure as estimated by glomerular filtration rate (GFR) \< 60mL/min/1.73 m\^2 at screening 13. History of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 14. History of previous bariatric surgery or transplant surgery 15. Patients with significant hematologic abnormalities, as defined by hemoglobin \< 8g/dL and/or white blood count \<1500 cells/microL 16. 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 17. Use of any medications that interfere with tirzepatide 18. Use of the following medications with glucose lowering properties in the last 30 days: GLP-1RA, GLP-1RA/GIPRA, insulin, metformin, sulfonylurea, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors 19. Use of the following medications: Any medication that requires intramuscular administration injections. Systemic corticosteroids 20. Use of any investigational drugs within 1 month, or five half-lives, whichever is longer, of the study procedures 21. Presence of any current suicidality or a lifetime history of suicide attempt or suicidal ideation within the past year 22. 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 23. History of liver decompensation events such as hepatic encephalopathy or ascites 24. History of severe gastroparesis 25. History of pancreatitis in the last 5 years or if subject has chronic pancreatitis For 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). Individuals 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

    Contact Email: •••••@•••••

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Other studies related to the condition(s) this trial covers.