QL Biopharm's Zovaglutide Achieves 13.8% Weight Loss with Monthly Dosing in Phase 2 Trial
核心洞察
QL Biopharm (搜索)'s zovaglutide (搜索) demonstrated 13.8% weight loss at 24 weeks with once-monthly 160 mg dosing in a Phase 2 trial of 303 overweight or obese subjects.
The novel GLP-1 receptor (搜索) agonist features dual-fatty acid chain modification that enhances albumin binding, enabling the first potential monthly dosing regimen in obesity (搜索) treatment.
Monthly dosing showed comparable efficacy to biweekly administration but with fewer gastrointestinal adverse events during maintenance therapy.
QL Biopharm (搜索) announced positive Phase 2 results for zovaglutide (搜索), a novel GLP-1 receptor (搜索) agonist that achieved significant weight loss with once-monthly dosing, potentially becoming the world's first monthly GLP-1 therapy for obesity (搜索) management. The randomized, double-blind, placebo-controlled trial results were presented at the European Association for the Study of Diabetes (搜索) (EASD) annual meeting.
Phase 2 Trial Design and Results
The multi-center study, led by Dr. Linong Ji of Peking University People's Hospital, enrolled 303 overweight or obese subjects who were randomized to receive subcutaneous injections of placebo or zovaglutide (搜索) at various dosing regimens for 24 weeks. Participants received maximum doses of 80 mg or 160 mg administered once monthly, or 80 mg or 160 mg delivered every two weeks.
The primary endpoint of percent change in body weight from baseline after 24 weeks showed remarkable efficacy across all zovaglutide (搜索) dose groups compared to placebo. Patients receiving once-monthly 160 mg zovaglutide experienced a 13.8% reduction in body weight, while those on 80 mg monthly dosing achieved 10.6% weight loss, compared to just 2.4% in the placebo group (p-value <0.0001).
Notably, the once-monthly 160 mg regimen demonstrated comparable efficacy to the 80 mg biweekly dosing (12.5% weight loss), suggesting that monthly administration can maintain therapeutic benefit while improving dosing convenience.
Safety and Tolerability Profile
The safety profile of zovaglutide (搜索) was consistent with the established GLP-1 receptor (搜索) agonist class. The most common treatment-related adverse events were nausea, vomiting, and diarrhea, occurring primarily during the dose escalation period and decreasing after reaching target doses. Most adverse events were mild to moderate in severity.
Importantly, the once-monthly 160 mg group experienced fewer gastrointestinal adverse events during maintenance therapy compared to the 80 mg biweekly group, despite receiving the same total monthly dose. Only one case (1.3%) of discontinuation occurred due to gastrointestinal adverse events, significantly lower than similar GLP-1 receptor (搜索) agonist drugs.
Innovative Drug Design
Zovaglutide (搜索)'s potential for monthly dosing stems from its innovative dual-fatty acid chain modification, which significantly enhances binding affinity to albumin in the blood. This enhanced binding confers a long half-life that supports monthly administration while maintaining safety and efficacy.
Additional benefits observed in the trial included improvements in cardiometabolic risk indicators such as waist circumference, blood pressure, blood glucose, blood lipids, and liver function tests. The proportion of participants achieving ≥5% weight loss ranged from 89.9% to 97.1% across zovaglutide (搜索) groups, compared to 13.0% with placebo.
Clinical Significance and Future Development
Dr. Ji emphasized the clinical importance of these findings, stating: "At present, GLP-1 RAs in the field of obesity (搜索) treatment are dosed weekly, and there is a huge unmet clinical demand for longer-acting drugs. Monthly dosing is therefore one of the main research and development directions of the next generation of GLP-1 RA drugs."
Dr. Xujia Zhang, Founder, Chairman and CEO of QL Biopharm (搜索), highlighted the milestone's significance: "This is a significant milestone that represents QL Biopharm's leading position in the GLP-1 RA monthly formulation world, fully reflecting the company's patient-centric philosophy, differentiated product development strategy, and efficient project execution."
The company plans to advance zovaglutide (搜索) into Phase 3 pivotal studies, with the goal of providing a monthly treatment option that could significantly improve convenience for long-term weight management and enhance patient quality of life. QL Biopharm (搜索), founded by former Novo Nordisk R&D team members, focuses on innovative medicines for metabolic and neurodegenerative diseases including obesity (搜索), diabetes (搜索), MASH (搜索), and Alzheimer's disease (搜索).