Monlunabant found effective for weight loss obesity and metabolic syndrome in phase 2a trial
Novo Nordisk today announced that in a phase 2a trial, monlunabant, a novel oral cannabinoid receptor 1 inverse agonist, was associated with weight loss in people with obesity and metabolic syndrome. Monlunabant, formerly INV-202, was part of the acquisition of Inversago Pharmaceuticals Inc. announced in August 2023.
The trial investigated the efficacy and safety of a once-daily 10 mg, 20 mg and 50 mg dose of monlunabant compared to placebo on body weight after 16 weeks in 243 people with obesity and metabolic syndrome1. People were equally randomised among the four treatment arms.
From a baseline body weight of 110.1 kg, all doses of monlunabant achieved a statistically significant weight loss compared to placebo. After 16 weeks of treatment, people treated with a once-daily 10 mg dose of monlunabant achieved a weight loss of 7.1 kg compared to a reduction of 0.7 kg with placebo2. Limited additional weight loss was seen at higher doses of monlunabant.
In the trial, the most common adverse events were gastrointestinal, with the vast majority being mild to moderate and dose dependent. Reporting of mild to moderate neuropsychiatric side effects, primarily anxiety, irritability, and sleep disturbances, was more frequent and dose dependent with monlunabant compared to placebo. No serious adverse events were reported in relation to neuropsychiatric side effects.
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