Novo’s Studies of GLP-1s for Addiction Limited to Ongoing Phase II

Despite comments made by a Novo Nordisk official this week, the company confirmed to BioSpace that it has no additional clinical trials of its GLP-1 drugs in addiction beyond a Phase II trial testing semaglutide and two other drugs with alcohol use as a secondary endpoint.

Thursday, Reuters reported that Martin Holst Lange, head of development at Novo, had told an online conference on Thursday that his company plans to investigate how its GLP-1 medicines can help people with addiction.

However, in response to questions from Biospace, a Novo spokesperson said that Lange was referring to already ongoing work studying semaglutide on liver damage and alcohol use, and that the company has no plans to study the drug in broader addiction indications.

“There is nothing else in terms of clinical trials we have ongoing in this space at the moment,” the spokesperson said in an email.

Novo currently markets its GLP-1 treatments, which both contain the active ingredient semaglutide, as Wegovy for weight loss and Ozempic for type II diabetes. However, there is an early but growing interest in the potential of these molecules to treat substance abuse disorders, their related effects and a bevy of other conditions.

The Phase II trial, launched in May 2024 and currently recruiting globally, is studying the effectiveness of semaglutide and two other drugs—cagrilintide, an amylin analogue, and NNC0194-0499, an FGF21 analog—used alone or in combination, in patients with alcoholic liver disease. Treatment of liver damage is that trial’s primary endpoint and alcohol consumption is a secondary endpoint.

Three months ago, Novo’s biggest competitor Eli Lilly shared its plans to study its own GLP-1 medicines in alcohol and drug abuse. While Lilly has not officially announced any trials, CEO David Ricks said at an event in December that the company would begin large studies of its obesity drugs in alcohol and drug abuse next year, according to Endpoints News.

Currently, pharmaceutical treatment for addiction and substance-use disorders is limited, with most treatments aimed at avoiding overdoses or reducing withdrawal symptoms. But the industry is attempting inroads, with psychedelic therapies like LSD and ketamine drawing attention from researchers and biopharma companies. Another area of interest is in vaccination. In 2021 the NIH awarded a $25 million grant to scientists at Boston Children’s Hospital to study a vaccine against opioids. The hope is that the vaccine would generate antibodies to prevent the molecules from crossing into the brain.

Novo is making progress with GLP-1 on another neurological front. In October 2024, semaglutide was linked with a significant reduction—40% to 70%—in the risk of Alzheimer’s disease in a real-world study of patients with type 2 diabetes. Novo is running two Phase III trials, EVOKE and EVOKE Plus, formally testing semaglutide in patients with Alzheimer’s. Those trials are expected to read out in September of this year.

MORE ON THIS TOPIC