MarketMORRISTOWN, N.J. · Event November 9, 2026
Altimmune's pemvidutide cut heavy drinking days in Phase 2
Pemvidutide met its primary endpoint on heavy drinking days, a result first announced in July. The new presentation adds secondary, weight, liver and side-effect data. The drug is investigational and not approved for any use.
Altimmune presented the full results of its Phase 2 RECLAIM trial on November 9, 2026, in a late-breaker session at The Liver Meeting, the annual conference of the American Association for the Study of Liver Diseases (AASLD) in Denver. The trial tested pemvidutide, an investigational peptide that activates both the glucagon and GLP-1 receptors, in adults with moderate-to-severe alcohol use disorder (AUD) who also had a body mass index above 25.
Altimmune first said in July that the trial met its primary endpoint. The conference presentation, described in a company release, filled in the secondary endpoints, weight and liver measures, and side effects. The company also said it is scheduled to hold an end-of-Phase 2 meeting with the FDA in December to discuss the design of a Phase 3 program in AUD.
What the trial showed
RECLAIM (NCT06987513) randomized about 100 people 1:1 to weekly pemvidutide injections or placebo for 24 weeks. Everyone also received a standardized behavioral intervention. The registry lists 100 enrolled and shows the trial as completed in July 2026.
The primary measure was the change in heavy drinking days per week, defined as at least five drinks in a day for men and at least four for women. Altimmune reported a drop of 4.20 days with pemvidutide and 2.75 days with placebo, a difference of 1.45 days (p=0.0014).
Two secondary measures matter most for regulators, because Altimmune says the FDA recognizes them as registrational endpoints:
- No heavy drinking days: 42.2% on pemvidutide versus 17.4% on placebo.
- A 2-level drop in WHO risk drinking level: 64.4% versus 34.8%.
Abstinent days rose to 38.9% of days versus 20.5% on placebo. Blood levels of phosphatidylethanol (PEth), a marker of recent alcohol intake, fell on pemvidutide and rose on placebo. Participants on pemvidutide lost 8.7% of body weight on average, compared with a gain of 0.4% on placebo.
Side effects
Gastrointestinal effects were the most common. Nausea occurred in 44% on pemvidutide versus 24% on placebo, vomiting in 18% versus 6%, diarrhea in 20% versus 10%, and constipation in 26% versus 6%. Treatment discontinuation was 20% on pemvidutide and 22% on placebo, according to the company.
Why it matters
Several companies are testing whether GLP-1-based drugs reduce drinking, and AUD has few drug options. Altimmune says only three drugs are FDA-approved for the condition. Pemvidutide’s pitch is that the glucagon component acts directly on the liver, which matters for heavy drinkers at risk of liver disease. Altimmune’s chief medical officer, Christophe Arbet-Engels, called the results “the most robust evidence presented to date for the treatment of alcohol use disorder.” That is the company’s view, not an independent assessment.
BioSpace reported that William Blair analysts expect Altimmune to need additional capital to fund a pivotal AUD program.
What is not known
- Peer review. The results come from a company release and a conference presentation. No full paper has been published.
- Durability. The trial ran 24 weeks. It is not known whether reductions in drinking last after treatment stops.
- Liver outcomes. RECLAIM measured drinking, weight and blood markers, not long-term liver disease or survival.
- The Phase 3 design. It depends on the December FDA meeting, and its size and timing have not been disclosed.
We will update this story after the FDA meeting or when the RECLAIM data are published.
What changed: key dates
| Date | What happened |
|---|---|
| Altimmune, Inc.: Altimmune Presents Positive Late-Breaking Pemvidutide Data at AASLD The Liver Meeting 2026 in Patients with Alcohol Use Disorder | |
| Event date for this report | |
| BioSpace: Altimmune gears up for FDA meeting on pivotal Phase 3 trial in alcohol use disorder | |
| Amino Wire published this report |
Frequently asked questions
What is pemvidutide?
An investigational peptide that activates both the glucagon and GLP-1 receptors in a balanced 1:1 ratio, according to Altimmune. It is being studied in MASH, alcohol use disorder and alcohol-associated liver disease, and is not approved for any use.
Are these results new?
Partly. Altimmune announced in July 2026 that RECLAIM met its primary endpoint. The November 9 presentation at AASLD added fuller secondary, weight, liver and side-effect data, and the company disclosed its December FDA meeting plan.
Does this mean pemvidutide will be approved for alcohol use disorder?
No. RECLAIM is a mid-stage trial of about 100 people. Altimmune still needs to agree on a Phase 3 design with the FDA and run larger trials before it could seek approval.
Sources
3 linked records- [1] Altimmune Presents Positive Late-Breaking Pemvidutide Data at AASLD The Liver Meeting 2026 in Patients with Alcohol Use Disorder
The Investor Relations website contains information about Altimmune's business for stockholders, potential investors, and financial analysts.
Altimmune, Inc. · Primary record
- [2] NCT06987513: RECLAIM Study, Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
ClinicalTrials.gov (sponsor: Altimmune, Inc.) Primary record
- [3]
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