Summary: In a clinical trial, oral semaglutide was found to significantly reduce heavy drinking days, daily cravings, and alcohol-related problems in adults with moderate-to-severe Alcohol Use Disorder (AUD).
Evaluating 50 adults seeking treatment for AUD, the study revealed that oral semaglutide, a GLP-1 receptor agonist widely prescribed for type 2 diabetes and weight management, consistently curtailed real-world heavy alcohol consumption and reduced cannabis use days.
With no new medications approved by the FDA for AUD in nearly two decades, these findings highlight oral semaglutide as a accessible, non-injectable therapeutic candidate that lowers alcohol-related harm even among individuals who are not seeking complete abstinence.
Key Facts
- First Clinical Evidence for Oral GLP-1 in AUD: While previous preclinical and early clinical studies evaluated injectable formulations, this trial provides the first double-blind evidence that oral semaglutide reduces harmful alcohol intake in treatment-seeking individuals.
- Reduction in Heavy Drinking Metrics: Participants receiving oral semaglutide experienced significantly fewer heavy drinking days and consumed less alcohol per drinking episode over the eight-week intervention.
- Craving and Problem Mitigation: Treatment led to lower day-to-day alcohol cravings, improved overall World Health Organization drinking risk levels, and fewer self-reported social and health problems related to alcohol use.
- Co-Occurring Substance Effects: Beyond alcohol outcomes, participants receiving oral semaglutide demonstrated a concurrent decrease in cannabis use days over the course of the trial.
- High Adherence and Safety: Oral semaglutide was well tolerated with mostly mild side effects, demonstrating high participant retention and adherence rates suitable for real-world medical practice.
Source: University of Colorado
A clinical trial led by researchers at CU Anschutz has found that oral semaglutide, a medication widely used for diabetes and weight loss, reduces heavy drinking in adults with Alcohol Use Disorder (AUD).
The study, published today in The American Journal of Psychiatry, evaluated the oral formulation of semaglutide, which may be more acceptable for people with AUD than the injectable formulations previously tested for AUD.
“This study suggests oral semaglutide may help reduce heavy and harmful drinking, even in people who are not trying to quit alcohol entirely,” said Joseph Schacht, PhD, associate professor at the CU Anschutz School of Medicine.
“It could represent a new treatment option for AUD, particularly for those who have not benefited from existing medications, and may reduce alcohol-related health and social harms. Importantly, even reducing heavy drinking can lead to meaningful improvements for patients and families.”
AUD is a chronic medical condition in which individuals have difficulty controlling alcohol use despite harmful consequences. It affects millions of people and remains difficult to treat, with limited medication options available. No new medications have been approved for AUD in nearly two decades, underscoring the urgent need for additional treatment approaches.
KEY FINDINGS
In an eight-week randomized, double-blind, placebo-controlled trial involving 50 adults seeking treatment for moderate-to-severe AUD, participants receiving oral semaglutide showed:
- Fewer heavy drinking days
- Reduced alcohol consumption per drinking occasion
- Lower day-to-day alcohol cravings
- Fewer alcohol-related problems
- Improved overall drinking risk level
- Reduced cannabis use days
While not all measures changed in controlled laboratory settings, the overall pattern showed consistent reductions in harmful real-world drinking behavior.
WHY THIS MATTERS FOR PATIENTS AND FAMILIES
“Alcohol Use Disorder can affect nearly every part of life, including physical health, mental health, relationships and safety. Many people do not respond to current treatments, highlighting a significant unmet medical need,” Schacht said. “With no new FDA-approved medications for AUD since 2006, identifying new therapeutic options is especially critical. For families, even modest reductions in heavy drinking can mean greater stability, fewer crises and improved quality of life.”
These findings suggest oral semaglutide may:
- Help people reduce harmful drinking even without full abstinence
- Offer a new treatment option for individuals who do not respond to existing medications
- Reduce alcohol-related health, safety and social harms
SAFETY AND NEXT STEPS
Oral semaglutide was generally well tolerated, with most side effects reported as mild. Study participants demonstrated high adherence and completion rates, supporting feasibility in real-world clinical settings.
Researchers emphasize that larger and longer-term studies are needed to confirm findings and determine optimal dosing and treatment strategies for Alcohol Use Disorder.
Funding: The study was funded in part by the National Institute on Alcohol Abuse and Alcoholism.
CU Anschutz and partner institutions are planning to conduct larger trials soon.
Key Questions Answered:
A: Oral formulations provide a convenient, needle-free daily medication option that can be integrated into primary care settings. For many individuals with AUD, taking a daily oral tablet is more acceptable, less stigmatizing, and easier to adhere to than weekly subcutaneous injections, which improves long-term compliance.
A: No. The study demonstrated that oral semaglutide produces meaningful reductions in heavy drinking days and consumption per occasion even in individuals who are not aiming for total abstinence. Reducing heavy drinking significantly decreases the risk of liver disease, cardiovascular crises, social disruption, and injury.
A: Not yet. While semaglutide is FDA-approved for type 2 diabetes (as Rybelsus for oral, Ozempic for injection) and chronic weight management (Wegovy), its use for AUD remains investigational. Larger phase 3 clinical trials are required before seeking an official regulatory indication for alcohol addiction.
Editorial Notes:
- This article was edited by a Neuroscience News editor.
- Journal paper reviewed in full.
- Additional context added by our staff.
About this neuropharmacology and AUD research news
Author: Laura Kelley
Source: University of Colorado Anschutz
Contact: Laura Kelley – University of Colorado Anschutz
Image: The image is credited to Neuroscience News
Original Research: Open access.
“Oral Semaglutide for Alcohol Use Disorder: A Randomized Clinical Trial” by Joseph P. Schacht, Joseph T. Sakai, Kristen Raymond, Robert Shelton. American Journal of Psychiatry
DOI:10.1176/appi.ajp.20260003
Abstract
Oral Semaglutide for Alcohol Use Disorder: A Randomized Clinical Trial
Objective:
Accumulating preclinical and observational evidence suggests that glucagon-like peptide-1 receptor agonists, including semaglutide, reduce alcohol consumption. This phase 2 double-blind, randomized, parallel-arm trial evaluated the effects of oral semaglutide on alcohol craving and consumption among treatment-seeking adults with alcohol use disorder (AUD).
Methods:
Fifty individuals with moderate to severe AUD were randomized to receive semaglutide (3 mg/day for 4 weeks, then 7 mg/day for 4 weeks) or placebo for 8 weeks. The primary outcome was laboratory-based alcohol cue-elicited craving at week 6. Key preregistered secondary outcomes were heavy drinking days and drinks per day during the last 4 weeks of treatment. Effects on other alcohol consumption measures, naturalistic alcohol craving, alcohol-related negative consequences, World Health Organization risk drinking level, and cannabis use were also explored.
Results:
Semaglutide did not significantly reduce laboratory-assessed craving or drinks per day compared with placebo, but significantly reduced heavy drinking days (b=−0.580, 95% CI=−1.012, −0.148). Semaglutide also significantly reduced drinks per drinking day (b=−1.177, 95% CI=−2.307, −0.047), naturalistic alcohol craving (b=−2.195, 95% CI=−4.174, −0.216), and cannabis use days (b=−1.434, 95% CI=−2.568, −0.301). Semaglutide reduced alcohol-related consequences at a significantly greater rate than placebo (b=−4.618, 95% CI=−8.651, −0.585). Significantly more participants in the semaglutide group than the placebo group reduced their risk drinking level by one or more levels (Wald χ2=4.01).
Conclusions:
These findings confirm previous results among non–treatment seekers with less severe AUD and suggest that continued development of semaglutide for AUD is warranted.
