According to the latest information from Clinical Trials. gov, Novo Nordisk will launch a phase II clinical trial on May 20th to evaluate the effects of three drugs, including Smegglutide, on liver function, degree of liver fibrosis, and alcohol intake in patients with alcoholic liver disease.
Although Novo Nordisk has previously made it clear that the company will not specifically conduct research on the effects of smeglutide on alcohol addiction, this latest clinical study lists improving liver function as the primary endpoint and changes in alcohol consumption as a secondary endpoint.
Novo Nordisk stated, "The medical demand for alcohol related liver disease is very significant, but it has not been met. The primary method of treating this disease is lifestyle intervention and avoiding alcohol consumption."
The upcoming trial is a randomized, blinded, parallel group phase II clinical trial, expected to recruit 240 adult patients with alcohol related liver disease. These patients self-reported a drinking history of at least 5 years and had an average daily alcohol intake of at least 50 grams (males)/40 grams (females) in the last year before signing the clinical admission consent form.
Previously, Novo Nordisk had conducted research on the treatment of non-alcoholic liver disease and metabolic disorders related liver diseases with smeglutide, and this study is the company's first study on the effectiveness of treating alcoholic liver disease.
Experts believe that this experiment may be of great significance in revealing how GLP-1 drugs alter people's addiction symptoms. GLP-1 was initially found to play a role in the intestine, but many studies have shown that GLP-1 drugs, which are more potent than natural hormones, may actually alter the neural circuits that drive desire.
Professor Qu Shen, Vice President of the Shanghai Endocrinologists Association and Chief Physician of the Endocrinology Department of the Tenth People's Hospital of Shanghai, stated in an interview with First Financial News that GLP-1 drugs actually have an effect on the human brain, inhibiting the response of the appetite center.
Novo Nordisk executives have also discussed this issue. Novo Nordisk CEO Lars Jorgensen stated last year, "One benefit of using smeglutide to treat obesity is that it can address this craving for snacks and food, inhibit the function of the 'craving center' in the brain, and may also be useful in changing some other addictions in the future."
Jorgensen did not explicitly point out that "quitting alcohol" may become a future application direction for Smegglutide, and stated that Novo Nordisk has no plans to specifically study the drug's efficacy in addiction. But he emphasized, "When we conduct large-scale research, there may be opportunities to collect data and use artificial intelligence to mine real-world medication experiences to obtain signals of the impact of drugs on alcohol consumption and other factors."
Addiction science researchers are already excited about this. Christian Hendershot, an assistant professor at the Department of Psychiatry and Bowles Alcohol Research Center at the University of North Carolina Chapel Hill in the United States, publicly stated, "This research direction is correct, and additional treatment options are indeed needed for individuals with alcohol addiction."
Previous animal experiments have preliminarily shown that semaglutide can reduce the alcohol consumption of rodents. According to a study published by Lorenzo Leggio, a researcher at the National Institutes of Health in May 2023, "One of the mechanisms by which drugs like Smegglutide reduce alcohol consumption is by reducing the 'reward effect' of alcohol, similar to the mechanism associated with the neurotransmitter dopamine."
If Smegglutide can demonstrate a substantial impact on alcohol intake, it will also have significant implications for the treatment of alcoholic liver disease. Over the past 40 years, the treatment of alcoholic liver disease has mainly relied on abstinence, nutritional therapy, and steroids.
Although the prospects are promising, researchers warn in a review in the journal Nature Medicine that these drugs should not be used to treat alcohol addiction problems such as alcoholism without clinical trials proving their safety and effectiveness, and clinical trials need to be rigorously controlled and scientifically rigorous.