Friday, Novo Nordisk A/S NVO announced headline results from a phase 2a clinical trial with monlunabant, a small-molecule oral cannabinoid receptor 1 (CB1) inverse agonist.
Monlunabant, formerly INV-202, was part of the acquisition of Inversago Pharmaceuticals Inc. for $1.075 billion, announced in August 2023.
The trial investigated the efficacy and safety of a once-daily 10 mg, 20 mg, and 50 mg of monlunabant compared to placebo on body weight after 16 weeks in 243 people with obesity and metabolic syndrome.
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 a placebo.
Limited additional weight loss was seen at higher doses of monlunabant.
The most common adverse events in the trial 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 about neuropsychiatric side effects.
Based on the results, Novo Nordisk expects to initiate a larger phase 2b trial in obesity in 2025 to further investigate dosing and the safety profile of monlunabant over a longer duration in a global population.
Earlier this week, NanoVation Therapeutics announced a multi-year partnership with Novo Nordisk to advance the development of novel genetic medicines targeting cardiometabolic and rare diseases.
Novo Nordisk will receive a defined exclusive, worldwide license to use NanoVation’s LNP technology for the two lead programs. NanoVation will receive research funding and is eligible to receive up to approximately $600 million in up-front cash, potential milestone payments, and tiered royalties on future product sales.
Price Action: NVO stock is down 5.49% at $127.48 at the last check on Friday.
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