Novel oral drug linked to weight loss in people with obesity, metabolic syndrome
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Key takeaways:
- In a phase 2a trial, monlunabant, a novel oral cannabinoid receptor 1 inverse agonist, was tied to weight loss in people with obesity and metabolic syndrome.
- A phase 2b trial is planned to be launched in 2025.
Novo Nordisk announced that monlunabant, a novel small molecule oral cannabinoid receptor 1 inverse agonist, was associated with weight loss in a phase 2a study of people with obesity and metabolic syndrome.
According to a press release from the company announcing top-line results, the study included 243 people with obesity and metabolic syndrome (mean body weight at baseline, 110.1 kg) who were randomly assigned to one of four groups: monlunabant 10 mg, 20 mg or 50 mg once daily; or placebo.
At 16 weeks, monlunabant 10 mg was associated with an average weight loss of 7.1 kg, compared with a loss of 0.7 kg for the placebo group, the company stated in the release.
The other two monlunabant doses conferred “limited additional weight loss” beyond that observed with the 10 mg dose, and all three doses were associated with statistically significant greater weight loss compared with placebo, according to the release.
The most common adverse events observed with monlunabant were gastrointestinal, most of which were mild or moderate, and were more frequent at higher doses, the company stated in the release.
Mild to moderate neuropsychiatric adverse events — mainly anxiety, irritability and sleep disturbances — were more common with monlunabant compared with placebo and were more frequent at higher doses, but there were no serious neuropsychiatric adverse events observed, according to the release.
“The phase 2a results indicate the weight-lowering potential of monlunabant and that further work is needed to determine the optimal dosing to balance safety and efficacy,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in the release. “Obesity is a complex disease with a significant unmet need, and as an oral small molecule having a new mechanism of action, monlunabant is one of the novel projects in our pipeline with the potential of treating obesity.”
A phase 2b trial of monlunabant, which will be in a global population and for a longer duration than the phase 2a trial, is expected to be launched in 2025, according to the release.
Monlunabant, formerly known as INV-202, was acquired by Novo Nordisk when it bought Inversago Pharmaceuticals in August 2023, according to the release.
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