QL Biopharm's Once-Monthly GLP-1 Candidate Shows Promise in Phase 2 Weight Loss Trial

Beijing-based QL Biopharmaceutical has unveiled promising phase 2 data for its once-monthly GLP-1 receptor agonist, zovaglutide (ZT002), demonstrating weight loss efficacy potentially rivaling weekly treatments from industry giants Eli Lilly and Novo Nordisk. The results mark a significant step forward in the development of ultra-long-acting obesity treatments, potentially offering patients a more convenient dosing regimen without compromising effectiveness.

Phase 2 Trial Results

The randomized trial, involving 303 overweight or obese participants in China, evaluated four dosing regimens of zovaglutide against a placebo. After 24 weeks, patients receiving zovaglutide experienced average weight loss ranging from 10.6% to 14.4%, compared to 2.4% in the placebo group. Notably, the 160 mg monthly dose achieved a 13.8% weight reduction, nearly matching the 14.4% loss observed with bi-weekly administration of the same dose.

QL Biopharm reported that weight loss had not yet plateaued at the 24-week mark, suggesting potential for further reductions with continued treatment. The company also highlighted that these results were numerically superior to 24-week phase 3 data from Lilly's tirzepatide (Zepbound) and Novo's semaglutide (Wegovy), both of which require weekly administration.

Safety Profile and Mechanism of Action

Zovaglutide's safety profile appears comparable to currently marketed GLP-1 drugs, with gastrointestinal adverse events decreasing once patients reached the target dose. Interestingly, the 160 mg monthly regimen was associated with a lower rate of gastrointestinal events than the 80 mg bi-weekly dosing.

The extended half-life of zovaglutide, enabling monthly dosing, is attributed to dual-fatty acid chain modifications that enhance binding affinity to albumin in the blood. Pharmacokinetic studies across multiple species indicate a two- to fourfold longer half-life compared to semaglutide.

Industry Implications and Future Directions

QL Biopharm's advancement of zovaglutide adds to the growing field of companies seeking to differentiate their GLP-1 offerings through less frequent dosing. Amgen's MariTide and Metsera's MET-097i are also targeting monthly administration, while Novo Nordisk, despite halting development of a monthly dual GLP-1/GIP receptor agonist, maintains interest in extended dosing intervals.

With these encouraging phase 2 results, QL Biopharm plans to progress the once-monthly zovaglutide regimen into phase 3 trials. As the obesity treatment landscape continues to evolve, the potential for monthly GLP-1 therapies could significantly impact patient adherence and market dynamics in this highly competitive space.