Zovaglutide

VIENNA — Eli Lilly was undoubtedly the star of this year’s congress of the European Association for the Study of Diabetes. Despite being slightly less effective than Novo Nordisk’s rival pill, Lilly’s oral obesity therapy orforglipron could do well in the market. And its diabetes shot Mounjaro looks likely to become the first of the new-generation incretins to crack the pediatric space. But many other companies also had a presence at the meeting in Vienna, some with GLP-1 therapies and some with more adventurous mechanisms. An update from the Phase 2 trial of Regeneron’s muscle-building drug trevogrumab was presented on Wednesday. The trial is assessing the ability of the anti-GDF8/anti-myostatin antibody to preserve lean mass in patients who are also taking Novo Nordisk’s obesity shot Wegovy. The new data showed that, of the weight lost by obesity patients after 26 weeks of therapy with Wegovy plus a low or high dose of trevogrumab, around 17% and 18% was lean mass, respectively. Of the weight lost by patients given Wegovy monotherapy, about 33% was lean mass. Updated data from the trial’s triplet arm, in which patients took Regeneron’s investigational anti-activin A antibody garetosmab as well as Wegovy and high-dose trevogrumab, were also presented. Here, just 7.4% of the weight lost was lean mass. These figures are not hugely different from the interim cut released in June . However, Regeneron reiterated that there were two deaths, both in the triplet group, that had been disclosed in June. In one case, the cause is unknown, although Regeneron said the patient had “multiple cardiovascular risk factors.” The second death was due to a cardiac arrest in a patient with a history of cardiovascular disease. Regeneron said it had “not identified a causal association” between the drug regimen and the deaths. The triplet regimen saw a “substantially higher” rate of discontinuations because of tolerability issues than the other two arms. Regeneron said that further studies are warranted, though it is unclear if this refers to the doublet or triplet regimen. Regeneron is separately seeking approval of garetosmab for the rare bone disease fibrodysplasia ossificans progressiva. Mid-stage trial data on a quadruple agonist developed by the California biotech Biomed Industries was also presented on Wednesday. Bioglutide, also called NA-931, is an oral small molecule that hits the receptors for GLP-1, GIP, glucagon and insulin-like growth factor-1 (IGF-1). In the 125-patient Phase 2 study, obesity patients taking one pill a day for 13 weeks had a maximum body weight reduction of 14.8% at the 150 mg daily dose, which calculates to 13.2 percentage points greater than placebo. Gastrointestinal adverse events were mostly mild, with nausea and vomiting reported as “insignificant.” Diarrhea occurred in 8.1% of bioglutide-treated subjects, compared to 3.2% in the placebo group. According to the EASD abstract, no muscle loss was observed. The company intends to take bioglutide into a Phase 3 program. Wednesday also saw presentation of results from a small Phase 1b/2a study of a GLP-1 developed by the Indian company Sun Pharmaceutical, in patients with obesity and metabolic dysfunction-associated fatty liver disease (MAFLD). In a subset of patients with BMI of less than 40 kg/m2 and blood sugar levels of at least 6.0%, their body weight fell by an average of 6.8% after 13 weeks of treatment with utreglutide. In the placebo group, weight fell by 3.1% but this group was not required to meet the same blood sugar criterion as those who received the drug. These patient groups were small, with just eight patients getting utreglutide and six receiving placebo. Utreglutide, with the codename GL0034, is also in a Phase 2 study in MASH with data due late next year or early in 2027. Another Asia-based biotech, Beijing QL Biopharmaceutical, presented data on a GLP-1 at the conference on Wednesday — this time, a long-acting shot with potential for monthly administration. Zovaglutide, also known as ZT002, was tested in around 300 nondiabetic obesity patients. Two doses, 80 mg or 160 mg, were given every two weeks and every four weeks in different groups. After six months, those given 80 mg monthly lost 10.6% of their weight, while those on the 160 mg monthly dose lost 13.8%. The same doses given every two weeks resulted in weight loss of 12.5% and 14.4%, respectively. All zovaglutide groups demonstrated statistically significant greater weight loss versus placebo, and no plateau was reached. Gastrointestinal adverse events (AEs) were similar to those of marketed GLP-1s, QL said , though one patient quit the trial due to gastrointestinal AEs. The company said that the data support a Phase 3 trial of monthly zovaglutide in obesity patients. Novo Nordisk reported a new data point from its early-stage trial of the GLP-1 and amylin combo shot known as amycretin on Tuesday. A cohort in the drug’s Phase 1b/2a obesity trial , whose dose was escalated up to 60 mg, lost 24.3% of their body weight at eight months, whereas placebo patients lost 1.1%. This was significantly higher, at a p-value of less than 0.001. The researchers said amycretin was “considered safe and tolerated” up to 60 mg. The most common TEAEs were nausea, vomiting and diarrhea, and most were mild to moderate. Editor’s note: This story was updated to note that the deaths in Regeneron’s study had already been disclosed, and that the company is seeking approval of garetosmab in a rare bone condition.

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. 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