QL Biopharm reports Phase 2 results of a monthly dose study evaluating zovaglutide, a novel, extended half-life GLP-1 receptor agonist at EASD 2025

Thu, 18 Sep 2025 21:00:00 +0800

• Patients who received zovaglutide at a once-monthly dose of 160 mg experienced a 13.8% reduction in body weight at 24 weeks, highly comparable to reductions observed in patients who received 80 mg every other week (12.5%)
• The overall safety and tolerability of zovaglutide were consistent and comparable with the GLP-1 receptor agonist class of obesity management drugs
• Gastrointestinal adverse events were observed less in the once-monthly 160 mg dose group in comparison to those receiving 80 mg biweekly

BEIJING, Sept. 18, 2025 /PRNewswire/ -- Beijing QL Biopharmaceutical Co., Ltd. (hereafter "QL Biopharm" or the "company") announced today at the European Association for the Study of Diabetes (EASD) annual meeting that its novel experimental therapy in the management of obesity met both its primary and secondary endpoints in a randomized, double-blind, placebo-controlled Phase 2 trial. The study consisted of a multi-center evaluation of the efficacy, safety and tolerability, and pharmacokinetics of zovaglutide, a novel, long-acting GLP-1 receptor agonist (RA) that was conducted in overweight or obese subjects.

The principal investigator of the study, Dr. Linong Ji of the Peking University People's Hospital, oversaw this trial entitled "Once-Monthly Zovaglutide (ZT002) for the Treatment of Overweight or Obesity in Adults: A Phase 2 Study" on behalf of the company. As presented by Dr. Ji at the EASD conference, a total of 303 overweight or obese subjects were randomized to receive subcutaneous injections of placebo (n=51) or zovaglutide at maximum doses of 80 mg (n=75) or 160 mg (n=76) administered once monthly (Q4W), or 80 mg (n=50) or 160 mg (n=51) delivered every two weeks (Q2W), for 24 weeks - inclusive of a dose escalation and a dose maintenance period. The primary endpoint was the percent change in body weight from baseline after 24 weeks of treatment, and secondary endpoints included the proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% after 24 weeks of treatment, absolute change in body weight from baseline, cardiometabolic risk factors, and safety/tolerability indicators.

The Phase 2 study's principal findings are as follows:

• Efficacy: The efficacy of zovaglutide in all dose groups (80 mg Q4W, 160 mg Q4W, 80 mg Q2W and 160 mg Q2W) at 24 weeks was better than that of the placebo group: percent change in body weight from baseline was -10.6%, -13.8%, -12.5% and -14.4% vs. -2.4%, respectively, with p-value <0.0001, and no plateau of efficacy was achieved over the duration of the study. The proportion of participants who lost ≥5% of their body weight from baseline by 24 weeks was 89.9%, 97.1%, 93.6% and 93.9% vs. 13.0%, respectively. 
• Safety and tolerability: Zovaglutide was tolerated well in all dose groups, and the overall incidence of gastrointestinal adverse events (AEs) was similar to that of marketed GLP-1 RA products. The most common treatment-related AEs were nausea, vomiting, and diarrhea, all which occurred mainly during the GLP-1 RA common dose escalation period.  Thereafter, these AEs decreased after the target dose was reached. Most AEs were mild or moderate in severity. Only one case (1.3%) of discontinuation occurred due to gastrointestinal AEs, which was significantly lower than that of similar GLP-1 RA drugs.
• Efficacy and safety in Q4W groups: The efficacy of zovaglutide in the 160 mg Q4W group was comparable to that of the 80 mg Q2W group.  However, fewer gastrointestinal AEs occurred during the maintenance therapy period in the 160 mg Q4W group in comparison to the 80 mg Q2W group (both groups receiving the same total monthly dose of zovaglutide). Further, the efficacy of zovaglutide in the 160 mg Q4W and 80 mg Q4W groups was dose-dependent.
• Other benefits of zovaglutide observed included improved cardiometabolic risk indicators including waist circumference, blood pressure, blood glucose, blood lipids, and liver function tests.
• Conclusion: The results of this Phase 2 study support the continued evaluation of once-a-month zovaglutide in a Phase 3 pivotal study in overweight and obese subjects.

Lead investigator Dr. Ji stated: "At present, GLP-1 RAs in the field of obesity 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. Zovaglutide - with an innovative dual-fatty acid chain design - has the advantage of being long-acting, enabling continuous and efficient weight loss treatment through a monthly dosing regimen, with good safety and tolerability, thereby significantly improving the convenience of long-term weight management and improving the quality of life of patients. We look forward to the follow-up of zovaglutide and opening a new era of monthly dosing in the field of obesity treatment. "

Dr. Xujia Zhang, Founder, Chairman and CEO of QL Biopharm stated: "We are very pleased to report the latest research results of the company's zovaglutide monthly formulation program at the 2025 EASD conference. 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. We will advance the pivotal Phase 3 clinical study of zovaglutide in order to furnish a monthly formulation treatment plan that can benefit a majority of patients as soon as possible."

About zovaglutide (ZT002)

The Phase 2 results of Zovaglutide demonstrate that this GLP1 RA may be the world's first GLP-1 RA requiring only once-monthly delivery. An innovative, dual-fatty acid chain modification to the peptide significantly enhances its binding affinity to albumin in the blood. This enhanced binding confers a long half-life to the peptide that supports monthly administration. While maintaining safety and efficacy, zovaglutide can improve patient compliance and has the potential to become the drug of choice for long-term weight management with a GLP-1 RA agent. Zovaglutide is currently being evaluated in a Phase 3 clinical trial.

About QL Biopharm

QL Biopharm is a patient-centric, innovative biopharmaceutical company focused on the advancement of innovative medicines for metabolic and neurodegenerative diseases including obesity, diabetes, MASH and Alzheimer's Disease. The company is committed to continuously improving patient health and patient quality of life. Its core team previously operated at Novo Nordisk's R&D center. QL Biopharm currently possesses an end-to-end value chain consisting of capabilities in drug discovery and R&D with bridging functions to in-house manufacturing and commercial production of GMP quality drug material and product. The company benefits from its proprietary E. coli technology platform, harboring independent intellectual property rights. QL Biopharm has achieved peptide scaling capabilities and a production capacity that surpasses industry standards, thereby affording it significant cost efficiencies.