Shares in Novo Nordisk (NYSE:NVO) fell more than 4% following the market open on Friday after the Danish pharma giant released data from a phase 2a clinical trial with its obesity drug, monlunabant.
Meanwhile, Viking Therapeutics (NASDAQ:VKTX), one of Novo’s rivals in the weight-loss market, saw its shares rise over 1%.
The trial assessed the efficacy and safety of monlunabant at daily doses of 10 mg, 20 mg, and 50 mg compared to a placebo in 243 individuals with obesity and metabolic syndrome, Novo Nordisk said.
Participants were equally randomized into four groups. Starting from an average weight of 110.1 kg, all monlunabant doses led to significant weight loss versus placebo.
After 16 weeks, the 10 mg dose resulted in a weight loss of 7.1 kg compared to just 0.7 kg for the placebo group. Higher doses showed limited additional benefits.
“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,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
“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.”
The most common side effects were gastrointestinal, mostly mild to moderate and dose-dependent.
Neuropsychiatric effects, such as anxiety, irritability, and sleep disturbances, were also more frequent with monlunabant but remained mild to moderate. No serious neuropsychiatric adverse events were reported.
Based on the results, Novo Nordisk plans to launch a larger phase 2b trial in 2025 to further explore the dosing and safety of monlunabant in treating obesity. This trial will focus on a global population and assess the treatment's effects over a longer period.