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Provided by AGPCHENGDU, China, May 18, 2026 (GLOBE NEWSWIRE) -- Vincentage Pharma Co., Ltd. (the “Company”) today announced positive top-line results from the Company’s pivotal Phase 3 trial evaluating its internally discovered, investigational, once-daily oral small molecule GLP-1 receptor agonist (GLP-1 RA), VCT220, in overweight or obese participants in China. The Company plans to submit a New Drug Application (NDA) for VCT220 for weight management to China’s National Medical Products Administration (NMPA) in the near term.
The Phase 3 trial (NCT06939296) enrolled 840 adults with obesity (BMI ≥28 kg/m²) or overweight (24 kg/m² ≤ BMI <28 kg/m²) with at least one weight-related comorbidity. Participants were randomized 1:1:1 to receive VCT220 120 mg, VCT220 160 mg, or placebo once daily for 52 weeks.
At 52 weeks, VCT220 achieved mean body weight reduction of -12.2% and -12.4% in the 120 mg and 160 mg groups, respectively, both significantly greater than -1.3% for placebo. Across the 52-week double-blind treatment period, VCT220 demonstrated favorable overall tolerability, with a safety profile consistent with existing GLP-1 therapeutics. The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity. No severe nausea or vomiting events were reported. Gastrointestinal adverse events (GIAEs) primarily occurred during dose escalation period and gradually subsided during maintenance period. Discontinuation rates due to treatment-related adverse events (TRAEs) were low at 1.8% and 1.8% in the 120 mg and 160 mg groups, respectively. No hepatic safety signal was observed.
"VCT220 is an internally discovered oral non-peptide small-molecule GLP-1 RA designed for once-daily administration without food or water restrictions, offering a dosing titration period as short as six weeks and no requirement for refrigerated or light-protected storage," said Ben Li, Ph.D., Chief Executive Officer of Vincentage. "We believe VCT220 has the potential to provide a more convenient, accessible, and sustainable treatment option compared to injectable therapies for people with obesity or overweight, which may help improve treatment initiation and long-term adherence. Based on these positive data, we plan to submit an NDA to China's NMPA in the near term for chronic weight management, with the goal of bringing VCT220 to people in need as soon as possible. Beyond these initial indications, we are continuing the clinical development of VCT220 across type 2 diabetes, hypertension, and other obesity-related cardiometabolic conditions, and look forward to the U.S. Phase 2 readout of CX11, the globally developed version of VCT220 being led by our partner, Corxel Pharmaceuticals, later this year."
"VCT220 is the second oral non-peptide small-molecule GLP-1 RA globally to complete a pivotal Phase 3 clinical trial for the treatment of obesity and ready for NDA submission, following Eli Lilly's orforglipron," said Professor Ji Linong, Director of the Department of Endocrinology at Peking University People's Hospital and principal investigator of the Phase 1, Phase 2, and Phase 3 clinical trials of VCT220. "We are very pleased to see that the Phase 3 trial of VCT220 successfully met its primary endpoints, demonstrating weight loss comparable to approved oral GLP-1 therapies and a favorable tolerability profile. I am extremely proud to have been part of the full clinical development journey of this novel, non-peptide GLP-1 RA with an entirely new molecular structure, independently developed by a Chinese pharmaceutical company. The successful development of VCT220 not only expands China's obesity treatment landscape, but also has the potential, through Corxel Pharmaceuticals' global clinical development efforts, to offer additional weight management options to people around the world. Building on the significant blood pressure improvements observed across the Phase 2 and Phase 3 trials, we have already initiated clinical trials evaluating VCT220 for the treatment of hypertension.”
About the Trial
The pivotal Phase 3 trial of VCT220 was initiated in November 2024. The trial was a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of VCT220 tablets in overweight or obese participants in China. The trial assessed 840 adults with obesity (BMI ≥28 kg/m²) or who were overweight (24 kg/m² ≤ BMI <28 kg/m²) with at least one weight-related comorbidity. Participants were randomized 1:1:1 to receive VCT220 120 mg, VCT220 160 mg, or placebo once daily for 52 weeks.
About VCT220
VCT220 is an oral, non-peptide small-molecule GLP-1 receptor agonist designed for once-daily administration without food or water restrictions, fixed dosing time requirements, refrigeration, or light-protected storage. VCT220 has the potential to provide a more convenient, accessible, and long-term treatment option for adults who are overweight or who are obese, which may help improve treatment acceptance and long-term adherence. In addition to obesity, Vincentage is exploring indications for VCT220 in type 2 diabetes, hypertension, and other cardiometabolic diseases.
In November 2024, Corxel Pharmaceuticals, a leading, global biotech company focused on bringing innovative medicines to patients with cardiometabolic diseases, acquired worldwide, ex-Greater China (mainland, Hong Kong, Macau, Taiwan) development and commercialization rights of VCT220. Corxel Pharmaceuticals is currently assessing VCT220, under the program name of CX11, in a Phase 2 obesity clinical trial in the U.S. and a Phase 2 global type 2 diabetes clinical trial.
About Vincentage Pharma
Since its establishment in 2021, Chengdu Vincentage Pharma Co., Ltd. has focused on the discovery and development of innovative therapies for metabolic diseases. Targeting major unmet clinical needs in obesity, hypertension, type 2 diabetes, and metabolic dysfunction-associated steatohepatitis (MASH), the Company has built a differentiated pipeline centered on oral small-molecule therapeutics. Leveraging its established small-molecule drug discovery and development platform, the Company continues to expand a product portfolio covering multiple metabolic pathways. Vincentage is committed to building an integrated solution encompassing weight management, metabolic improvement, and long-term health management, while continuously strengthening and enhancing its competitiveness in the global metabolic disease field.
Media Contact
Miles Zhang
bd@vincentage.com
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