First randomized trial of semaglutide for alcohol use disorder published

Researchers have published the first randomized, placebo-controlled trial testing semaglutide for alcohol use disorder. In 48 adults who were not seeking treatment for their drinking, nine weeks of low-dose weekly semaglutide reduced how much alcohol people drank in a laboratory setting and lowered weekly alcohol craving compared with placebo ^[3].

The study was a phase 2, double-blind trial run at a US academic medical center, with enrollment from September 2022 to February 2024 ^[3]. Of 504 people screened, 48 were randomized ^[3]. Participants were 71% female (34 of 48) with a mean age of 39.9 years ^[3]. They received either placebo or semaglutide at doses well below those typically used for weight loss: 0.25 mg per week for four weeks, 0.5 mg per week for four weeks, and 1.0 mg for one final week ^[3].

What the trial measured

The main outcome was a laboratory "self-administration" task. A week before the first injection, participants were invited to drink their preferred alcoholic beverages over two hours in a comfortable lab setting, with the option to delay drinking; researchers recorded delays and drinks consumed ^[2]. The task was repeated after treatment ^[2].

After treatment, the semaglutide group consumed less alcohol in the lab, with medium to large effect sizes for grams of alcohol consumed (β, −0.48; 95% CI, −0.85 to −0.11; P = .01) and peak breath alcohol concentration (β, −0.46; 95% CI, −0.87 to −0.06; P = .03) ^[3]. That analysis included only the 25 participants with complete self-administration data — 12 on placebo and 13 on semaglutide ^[3].

In day-to-day drinking outside the lab, the results were mixed. Semaglutide did not change average drinks per calendar day or the number of drinking days ^[3]. It did significantly reduce drinks per drinking day (β, −0.41; 95% CI, −0.73 to −0.09; P = .04) and weekly alcohol craving measured on the Penn Alcohol Craving Scale (β, −0.39; 95% CI, −0.73 to −0.06; P = .01), and it predicted greater reductions in heavy drinking over time than placebo (β, 0.84; 95% CI, 0.71 to 0.99; P = .04) ^[3].

Among the small subgroup who smoked cigarettes at the start, semaglutide was linked to greater reductions in cigarettes per day (β, −0.10; 95% CI, −0.16 to −0.03; P = .005) ^[3]. The university's release notes that no medication is currently approved for both alcohol reduction and smoking cessation ^[2].

Why it matters for patients

Semaglutide is approved in the US as Ozempic for type 2 diabetes and Wegovy for obesity ^[2]. Alcohol use disorder is not an approved use, and this trial does not change that. Three drugs are FDA-approved for alcohol use disorder, and the researchers note they are underused ^[2]. An estimated 178,000 US deaths per year are attributed to alcohol ^[2].

People taking GLP-1 drugs have widely reported drinking less, and the senior author said those anecdotal reports helped motivate the trial ^[2]. This study offers the first randomized evidence behind those reports, but it is small and short: 48 people, nine weeks, low doses, and participants who were not trying to quit drinking ^[3]. The authors describe the findings as initial evidence that justifies larger trials ^[3]. The university release calls the data preliminary and says longer studies are needed to define long-term effects, ideal doses, and treatment durations, which may differ from those used for diabetes and obesity ^[2].

Also worth knowing: the effect on the most common real-world yardstick — average drinks per day across the whole week — was not significant ^[3]. The clearest signals were in a controlled lab drinking session, in craving scores, and in how much people drank on the days they did drink ^[3].

What happens next

The trial was registered as NCT05520775 and was funded by a National Institute on Alcohol Abuse and Alcoholism grant (R21AA026931) ^[2][3]. The senior author reported consulting fees from Novo Nordisk outside the submitted work and institutional research contracts from several drugmakers, including Novo Nordisk and Eli Lilly ^[3].

The sources do not name any specific larger trial, timeline, or regulatory filing for semaglutide in alcohol use disorder, so what comes next — and when — is not yet known from this reporting.