Altimmune says pemvidutide cut heavy drinking days by 1.45 a week against placebo in a Phase 2 trial

Altimmune said on Monday, November 9, that its experimental drug pemvidutide reduced heavy drinking days in a Phase 2 study of adults with moderate-to-severe alcohol use disorder, adding to early evidence that a class of medicines better known for metabolic disease may also affect alcohol consumption.

The company released the results during a late-breaking presentation at AASLD The Liver Meeting 2026 in Denver. The findings came from RECLAIM, a 24-week trial that randomly assigned about 100 patients to receive either weekly pemvidutide or placebo along with a standardized behavioral intervention. Pemvidutide is an investigational dual glucagon/GLP-1 receptor agonist and has not been approved for alcohol use disorder.

According to Altimmune, patients who received pemvidutide reduced heavy drinking days, defined in the study as days with at least five drinks for men and four for women, by 4.20 days per week by Week 24, compared with a 2.75-day reduction in the placebo group. The treatment difference was 1.45 days, with a reported p value of 0.0014. The company said the separation between the groups was visible by Week 4.

Altimmune also reported that 42.2% of patients on pemvidutide reached zero heavy drinking days, compared with 17.4% on placebo. It said 64.4% achieved a two-level reduction in the World Health Organization’s risk drinking category, versus 34.8% with placebo, and that abstinent days rose to 38.9% in the treatment group, compared with 20.5% in the placebo arm. Drinks per drinking day also fell more in the pemvidutide group, by 4.9 drinks, compared with 3.8 drinks in the control group.

The company said a biomarker of alcohol intake, phosphatidylethanol or PEth, fell by 153.4 ng/mL in the pemvidutide group, while it rose by 22.0 ng/mL in the placebo group. Because PEth is a biochemical measure rather than a self-reported one, the result may help support the reported change in drinking behavior, though the findings still need confirmation in larger trials.

The trial also showed changes outside alcohol use. Altimmune said patients treated with pemvidutide lost an average of 8.7% of body weight, while those on placebo gained 0.4%. Among participants who started the trial with elevated FIB-4, a noninvasive marker associated with liver fibrosis risk, 50% in the treatment group moved into the normal range, compared with 17% in the placebo group.

Safety remains a central issue for any drug in this category, and Altimmune said pemvidutide was generally well tolerated. The most common side effects were gastrointestinal. Nausea was reported in 44% of patients receiving the drug, compared with 24% on placebo. Vomiting occurred in 18% versus 6%, diarrhea in 20% versus 10%, and constipation in 26% versus 6%. Treatment discontinuation rates were similar, at 20% for pemvidutide and 22% for placebo.

The study population was limited. RECLAIM enrolled adults with alcohol use disorder who also had a body mass index above 25 kg/m2, which means the results may not apply in the same way to all patients with the disorder. The trial was also relatively small, and the data were presented by the company at a medical meeting rather than through a full peer-reviewed publication.

Even so, the results are likely to draw attention because alcohol use disorder has few drug treatment options and because researchers have been closely watching whether GLP-1-based medicines can reduce cravings or reward-driven behavior beyond food intake. Altimmune said pemvidutide has balanced 1:1 glucagon and GLP-1 activity, and the company argues that profile may be relevant both to metabolic disease and to alcohol-related behavior.

The company said it plans to hold an end-of-Phase 2 meeting with the Food and Drug Administration in December to discuss the design of a registrational Phase 3 program in alcohol use disorder. Whether the drug can advance will depend on larger studies that confirm the effect, clarify durability, and further define safety.

The announcement also has potential implications beyond drug development. Alcohol makers and investors have been monitoring research on GLP-1 and related medicines because, if future studies confirm a meaningful reduction in alcohol intake, the drugs could eventually influence demand for beer, wine and spirits in some consumer groups. That effect remains speculative at this stage, especially because pemvidutide is still experimental and the current findings come from a mid-stage trial in a specific patient population rather than the broader public.

Altimmune used the same meeting to present additional data from IMPACT, a separate Phase 2b study in metabolic dysfunction-associated steatohepatitis, or MASH. The company said those analyses showed reductions in liver stiffness, ELF score, liver fat and alanine aminotransferase compared with placebo. While those results involve a different disease area, Altimmune has been positioning pemvidutide as a drug that could address overlapping metabolic and liver conditions, including alcohol-associated liver disease.

Alcohol use disorder affects an estimated 28 million adults in the United States, according to figures cited by the company. Existing approved drugs are used by a small share of patients, and many people with the disorder also have obesity, fatty liver disease or other related conditions. That overlap helps explain why drugmakers are now testing treatments that may act on both metabolic pathways and addiction-related behavior.

For now, the new data provide one more signal that GLP-1-linked medicines could have uses outside diabetes and weight loss. But the outcome that matters most for regulators, doctors and patients is whether those signals hold up in larger trials designed to support approval. Altimmune’s next step is to persuade the FDA that the Phase 2 results justify that move.