Novo Nordisk Releases Phase 2a Obesity Treatment Data

Novo Nordisk has recently completed a phase 2a clinical trial of monlunabant, an oral cannabinoid receptor 1 (CB1) inverse agonist, designed for treating obesity. The trial involved 243 participants who were grappling with obesity and metabolic syndrome. Over a 16-week period, participants received daily doses of 10 mg, 20 mg, or 50 mg of monlunabant. The results revealed that all dosages led to notable weight loss when compared to a placebo.

Specifically, those on the 10 mg dose experienced an average weight reduction of 7.1 kg, whereas the placebo group saw a minimal weight loss of 0.7 kg. This significant difference underscores the potential effectiveness of monlunabant in weight management.

Throughout the trial, common side effects were observed, with gastrointestinal issues being the most prevalent. These side effects were generally mild to moderate and appeared to be dose-dependent. Additionally, higher doses were associated with an increase in neuropsychiatric side effects, including anxiety, irritability, and sleep disturbances. However, it is important to note that there were no reports of serious adverse events within the study.

Moving forward, Novo Nordisk is preparing to initiate a phase 2b trial in 2025. This upcoming trial will focus on refining the dosing regimen and assessing the long-term safety of monlunabant, with particular attention to its side effect profile.

In a related development, the European Medicines Agency (EMA) has scrutinized weight loss medications for potential mental health risks. This scrutiny led to a review of Novo Nordisk's diabetes drug, Ozempic, following two reports from Iceland suggesting a potential link to suicidal ideation and self-harm. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) sought to determine if these mental health issues were connected to Ozempic and expanded their review to include other GLP-1 drugs such as Saxenda and Wegovy.