Vincentage Pharma's Oral GLP-1 Agonist VCT220 Achieves 12% Weight Loss in Pivotal Phase 3 Trial
核心洞察
Vincentage Pharma (搜索)'s oral GLP-1 receptor agonist VCT220 demonstrated significant weight loss of 12.2% and 12.4% at 120mg and 160mg doses respectively in a 52-week Phase 3 trial.
The study enrolled 840 Chinese adults with obesity or overweight conditions, showing superior efficacy compared to placebo's 1.3% weight reduction.
VCT220 represents only the second oral non-peptide small-molecule GLP-1 agonist globally to complete pivotal Phase 3 obesity trials, following Eli Lilly's orforglipron.
Vincentage Pharma (搜索) Co., Ltd. announced positive top-line results from its pivotal Phase 3 trial evaluating VCT220, an investigational once-daily oral small molecule GLP-1 receptor agonist, 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.
Trial Design and Results
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. The multicenter, randomized, double-blind, placebo-controlled clinical trial was initiated in November 2024.
Safety Profile
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.
Drug Characteristics and Development
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. The drug offers a dosing titration period as short as six weeks.
"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.
Global Development Strategy
In November 2024, Corxel Pharmaceuticals (搜索) 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.
Ben Li, Ph.D., Chief Executive Officer of Vincentage, stated: "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."
Expanded Therapeutic Applications
Beyond obesity treatment, Vincentage is exploring indications for VCT220 in type 2 diabetes, hypertension, and other cardiometabolic diseases. Building on significant blood pressure improvements observed across the Phase 2 and Phase 3 trials, the company has already initiated clinical trials evaluating VCT220 for the treatment of hypertension.
Since its establishment in 2021, Chengdu Vincentage Pharma (搜索) 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).