Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 28-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.

Key facts

Study ID

NCT07218354

Run by

VA Office of Research and Development

People needed

622

Starts

2026-07-28

Expected to finish

2030-03-30

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Veteran.
• WHO risk drinking level of Very High or High in the 28 days prior to screening
• Current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam
• Able and willing to provide informed consent
• Has a desire to reduce their alcohol consumption

You may not qualify if…

• Medical and Psychiatric:
• Type 1 diabetes
• Current serious psychiatric illness (any psychotic disorder, bipolar 1 disorder, psychotic major depression, antisocial personality disorder, bulimia, or anorexia)
• Current DSM-5 diagnosis of a SUD (other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders)
• At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) >8)
• Body mass index (BMI) <21 kg/m2
• Unstable body weight defined as >5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization
• History of acute or chronic pancreatitis
• History of diabetic ketoacidosis
• History of proliferative diabetic retinopathy
• History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma (HCC)
• History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy
• Presence of gastroparesis
• History of acute gallbladder disease in the prior 6 months
• History of advanced fibrosis or cirrhosis, including (but not limited to) transient elastography (liver stiffness) of >12 kPa, FIB-4 >= 2.67, ELF >= 9.8, MRE >= 3.63 kPa
• History of esophageal varices on endoscopy or imaging
• History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging
• History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin > 1.5 times the upper limit of normal)
• History of primary biliary cholangitis
• History of primary sclerosing cholangitis
• History of autoimmune liver disease
• History of hemochromatosis
• History of Wilson's disease
• History of alpha1 antitrypsin deficiency related liver disease
• Current drug-induced liver disease

Where it is running

• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (enrolling)
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (enrolling)
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (enrolling)
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (enrolling)
• Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States (enrolling)
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (enrolling)
• Asheville VA Medical Center, Asheville, NC — Asheville, North Carolina, United States
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• Corporal Michael J. Crescenz VA Medical Center — Philadelphia, Pennsylvania, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States
• William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States
• Orlando VA Healthcare System, Orlando, FL — Orlando, Florida, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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