Research

NIH announces the first randomized win for a GLP-1 drug in alcohol use disorder

A 108-person randomized trial found weekly semaglutide added to therapy cut heavy drinking days more than placebo in adults with alcohol use disorder and obesity, but the drug is not approved for that use.

By the Semaglutides news desk·

The National Institutes of Health said on April 30, 2026 that a randomized controlled trial is the first to show a GLP-1 receptor agonist can reduce heavy drinking days in patients who have both obesity and alcohol use disorder [1]. The study, led by researchers at Copenhagen University Hospital with NIH scientists and international colleagues, was published in The Lancet [1].

The trial enrolled 108 treatment-seeking adults with alcohol use disorder and co-occurring obesity [1]. Everyone received standard cognitive behavioral therapy. On top of that, participants were randomly assigned to weekly semaglutide or weekly placebo for 26 weeks, in a double-blind design [1]. Researchers tracked self-reported drinking and also measured several quantitative biomarkers [1].

What the trial found

Participants taking semaglutide had a 41.1% reduction in heavy drinking days, which the NIH described as a 13.7% greater reduction than the placebo group [1]. Blood-alcohol biomarkers supported the findings based on self-reported data [1]. The NIH release does not publish the placebo group's own reduction figure, and it describes the gap as a percent rather than percentage points, so the exact placebo number is not confirmed by the announcement itself [1].

The researchers also reported a number needed to treat of 4.3 [1]. That metric estimates how many people have to be treated for one additional person to benefit; lower numbers suggest a stronger effect. By comparison, the NIH says the number needed to treat for currently approved alcohol use disorder medications is 7 or higher [1].

As expected with a GLP-1, the semaglutide group also saw more pronounced decreases in body weight, blood pressure and other clinical measures [1]. The authors noted some adverse effects, including gastrointestinal symptoms, which they described as transient and mild [1]. The release does not break out how many participants had side effects, how many stopped treatment, or what semaglutide dose was used [1].

This result follows an earlier clinical trial in which a GLP-1 had no effect on heavy drinking across the study population as a whole, though a subgroup with obesity responded strongly [1]. That is why the new study enrolled only patients who had both conditions [1].

"Very few medications are currently approved for alcohol use disorder, and these are vastly underutilized. A new option that is more accessible and more effective could be a gamechanger for closing the treatment gap," said George Koob, Ph.D., director of the National Institute on Alcohol Abuse and Alcoholism and a study co-author [1].

Nora Volkow, M.D., director of the National Institute on Drug Abuse and also a co-author, said, "We're beginning to see some of that potential for GLP-1s to treat drug addiction turn into reality. Questions remain but this is nonetheless very encouraging" [1].

Why it matters for patients

Semaglutide is sold in the US as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for weight management. It is not approved by the FDA to treat alcohol use disorder, and the NIH announcement does not describe any regulatory filing or approval pathway for that use [1]. A single 26-week trial in 108 people is small and short, and the NIH release notes the authors themselves want to test longer treatment in a larger population before the findings are considered confirmed [1].

The trial also does not answer whether semaglutide would help people with alcohol use disorder who do not have obesity. That question is unresolved: the earlier trial cited by NIH found no overall effect, with benefit concentrated in participants who had obesity [1]. And every participant in the new study received cognitive behavioral therapy, so the result describes semaglutide added to therapy, not semaglutide alone [1].

What happens next

The research team plans to study the effects of GLP-1 drugs over a longer duration and in a larger population to confirm the findings [1]. No timeline, trial size or start date for that follow-up work was given [1]. The full paper is available in The Lancet under DOI 10.1016/S0140-6736(26)00305-3 [1][2]. The first author is Mette Kruse Klausen, M.D., and the corresponding author is Anders Fink-Jensen, D.M.Sc., both at Copenhagen University Hospital [1].

Sources

  1. https://www.nih.gov/news-events/news-releases/adding-weekly-glp-1-cognitive-behavioral-therapy-further-reduces-heavy-drinking
  2. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00305-3/fulltext

Semaglutides.org is for information only and is not medical advice. Always talk to a licensed healthcare provider about your own care. Some links to telehealth services are affiliate links, labeled where they appear.