Context:

MariTide, a novel once-monthly GLP-1 drug developed by Amgen, demonstrated significant weight loss potential in a phase 2 clinical trial, with participants losing up to 20% of their body weight. This drug, which combines GLP-1 effects with a long-acting antibody, offers an advantage over existing treatments like Ozempic and Mounjaro by requiring less frequent administration. Participants with obesity, including those with type 2 diabetes, showed improvements in weight and glycated hemoglobin levels. Although side effects were similar to other GLP-1 drugs, with mild gastrointestinal issues being most common, MariTide's unique formulation may support less frequent dosing without compromising effectiveness. Future phase 3 trials are essential to confirm these findings and address questions regarding trial completion rates and long-term effects before potential FDA approval and market availability in two to three years.

Dive Deeper:

• MariTide is a promising new GLP-1 drug from Amgen that combines GLP-1 effects with a long-acting antibody, allowing for once-monthly injections, a more convenient alternative to the weekly shots required by other treatments like Ozempic and Mounjaro.

• In a year-long phase 2 trial, MariTide helped participants lose up to 20% of their body weight, with those also having type 2 diabetes experiencing improved glycated hemoglobin (HbA1C) levels.

• The drug functions by containing a GLP-1 receptor agonist to suppress appetite and a GIP receptor antagonist to regulate blood sugar, with the added benefit of a monoclonal antibody that extends its effects in the bloodstream, potentially allowing for monthly dosing.

• Trial participants reported mild-to-moderate gastrointestinal side effects such as nausea, vomiting, and diarrhea, similar to other GLP-1 drugs, but these were generally less severe for those starting on lower doses of MariTide.

• The phase 2 trial had a high dropout rate, which was not attributed to the side effects, prompting further investigation in ongoing studies to understand the reasons behind this and to evaluate long-term weight maintenance.

• Phase 3 trials will further assess MariTide's efficacy and safety over 72 weeks, testing its impact on patients with various comorbidities and adjusting dosing strategies to minimize side effects.

• Researchers anticipate that if phase 3 trials confirm the drug's benefits and safety, MariTide may receive FDA approval and be available on the market within two to three years, marking a significant advancement in obesity and diabetes treatment.