Altimmune says pemvidutide cut heavy drinking in Phase 2 alcohol use disorder trial

Altimmune said on July 28, 2026 that pemvidutide, its investigational dual glucagon/GLP-1 drug, met the primary endpoint of a Phase 2 trial in adults with moderate to severe alcohol use disorder (AUD) ^[1]. The company described the reduction in heavy drinking days as statistically significant and clinically meaningful, and said it plans to request an End-of-Phase 2 meeting with the FDA to discuss the path forward ^[1].

The RECLAIM trial randomized about 100 patients with a body mass index above 25 to weekly 2.4 mg pemvidutide or placebo for 24 weeks ^[1]. On the primary endpoint — change from baseline in heavy drinking days per week — the pemvidutide group fell by 4.20 days on average, compared with 2.75 days for placebo, a difference of 1.45 days (p=0.0014) ^[1].

Several secondary measures also favored pemvidutide. A two-level reduction in World Health Organization risk drinking levels was reached by 64.4% of pemvidutide patients (29 of 45) versus 34.8% on placebo (16 of 46), with an odds ratio of 3.31 (p=0.0049). Zero heavy drinking days during weeks 21 through 24 was reported by 42.2% (19 of 45) versus 17.4% (8 of 46), an odds ratio of 3.84 (p=0.0066) ^[1]. Those two measures are recognized by the FDA as registrational endpoints, meaning they can support a future approval filing ^[1].

The share of days abstinent rose by 38.9% from baseline with pemvidutide and 20.5% with placebo, an 18.4 percentage-point difference (p=0.0075) ^[1]. Levels of phosphatidylethanol (PEth), a blood marker of alcohol intake, changed by -153.4 with pemvidutide and +22.0 with placebo at week 24, a difference of -175.3 (p<0.0001) ^[1].

"These results provide a consistent picture of treatment benefit on self-reported drinking outcomes, supported by objective PEth biomarker evidence," said Henry Kranzler, M.D., principal investigator of the trial and director of the Center for Studies of Addiction at the University of Pennsylvania Perelman School of Medicine ^[1].

Gastrointestinal side effects were more common on the drug. Nausea was reported by 44% of pemvidutide patients versus 24% on placebo, constipation by 26% versus 6%, diarrhea by 20% versus 10%, and vomiting by 18% versus 6% ^[1]. Severe adverse events occurred in 6 patients (12%) on pemvidutide and 3 (6%) on placebo; serious adverse events in 2 (4%) and 1 (2%) ^[1]. Five pemvidutide patients (10%) stopped treatment because of side effects the investigators linked to the drug, compared with none on placebo; those were two cases of vomiting and one each of constipation, fatigue and a hemorrhoid flare ^[1]. One serious event in the pemvidutide arm, low blood sodium, was judged possibly related to treatment ^[1]. Total discontinuations were similar between groups: 10 (20%) on pemvidutide and 11 (22%) on placebo ^[1].

Altimmune said a new two-step titration schedule for the 2.4 mg dose may improve gastrointestinal tolerability compared with earlier pemvidutide dosing plans ^[1].

Pemvidutide is not approved for any use. It is designed to act on both glucagon and GLP-1 receptors in a 1:1 ratio, a different profile from approved GLP-1 medicines such as Ozempic, Wegovy and Rybelsus (semaglutide) or Mounjaro and Zepbound (tirzepatide) ^[1]. The FDA has granted pemvidutide Fast Track designation for both MASH and AUD and Breakthrough Therapy designation for MASH ^[1].

Why it matters for patients

There is no GLP-1 medicine approved to treat alcohol use disorder. Altimmune estimates that about 28 million U.S. adults have AUD, roughly 12 million of them with moderate or severe disease, and that the three FDA-approved AUD drugs are used by less than 2% of patients ^[1]. This trial did not compare pemvidutide with those drugs, so how it stacks up against them has not been reported.

These results come from a single 100-patient study that ran 24 weeks, and heavier drinking was measured largely by patient report, with the PEth blood marker as a supporting measure ^[1]. Whether the effect holds over longer periods has not been reported. The same class of drugs commonly causes nausea, vomiting and constipation, and in this trial more pemvidutide patients had those symptoms than placebo patients ^[1]. Anyone taking a GLP-1 medicine for another reason should know that this trial tested a different, unapproved drug, not semaglutide or tirzepatide.

What happens next

Altimmune said it plans to request an End-of-Phase 2 meeting with the FDA about pemvidutide in AUD ^[1]. The date of that meeting and the FDA's response have not been disclosed. The company said full RECLAIM results will be submitted for presentation at a medical conference and for publication in a peer-reviewed journal, without giving dates ^[1].

Separately, Altimmune said it expects to finish enrollment in the RESTORE trial of pemvidutide in alcohol-associated liver disease in the third quarter of 2026 and to start the Phase 3 PERFORMA trial in MASH in the same quarter ^[1].