Development

Vincentage Pharma's oral GLP-1 achieves 12% weight loss in China Phase III

Vincentage Pharma, a Chengdu-based metabolic disease company, reported that VCT220, its oral small-molecule GLP-1 receptor agonist, produced mean body weight reductions of approximately 12% over 52 weeks in obese or overweight Chinese adults, clearing placebo by a wide margin and positioning the company to file for regulatory approval in China.

VCT220 Phase 3 trial results at a glance

The pivotal Phase III trial (NCT06939296) is a multicenter, randomized, double-blind, placebo-controlled study that enrolled 840 adults in China 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. The trial was initiated in November 2024.

Key efficacy and safety findings

At 52 weeks, participants in the 120 mg group achieved a mean body weight reduction of 12.2%, and those in the 160 mg group achieved 12.4%, compared with 1.3% in the placebo group. Both active doses met the primary endpoint with statistical significance. The two dose levels produced closely similar results, suggesting the dose-response curve may be relatively flat between 120 mg and 160 mg, though the company has not yet disclosed whether the difference between doses was statistically meaningful.

Safety findings were consistent with the established profile of the GLP-1 receptor agonist class. Gastrointestinal adverse events were the most commonly reported, generally mild to moderate in severity, and concentrated during the dose-escalation period before subsiding during maintenance. No severe nausea or vomiting events were reported. Discontinuation rates due to treatment-related adverse events were 1.8% in each active arm, and no hepatic safety signal was identified.

What the data mean for VCT220 obesity treatment positioning

VCT220's primary differentiating feature is its oral, non-peptide small-molecule format. All GLP-1 receptor agonists currently approved in China for weight management — including semaglutide, liraglutide, beinaglutide, mazdutide, and ecnoglutide — require subcutaneous injection. Orlistat, the only oral approved option, operates through a different mechanism and produces substantially more modest weight reduction. An oral GLP-1 receptor agonist that achieves double-digit percentage weight loss could address a meaningful gap in the China obesity treatment landscape, particularly given documented adherence challenges associated with injectable therapies.

The compound is designed for once-daily administration without food or water restrictions, does not require refrigeration or light-protected storage, and has a titration period as short as six weeks. These characteristics distinguish it from Novo Nordisk's Rybelsus (oral semaglutide), which requires fasting administration and specific timing constraints, and from the injectable agents that dominate the current GLP-1 receptor agonist weight management market in China.

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The most direct mechanistic comparator in the oral non-peptide small-molecule class is Eli Lilly's orforglipron, which secured a first approval in the US in April. Vincentage's principal investigator, Professor Ji Linong of Peking University People's Hospital, described VCT220 as the second oral non-peptide small-molecule GLP-1 receptor agonist globally to complete a pivotal Phase III trial for obesity ready for NDA submission, following orforglipron.

The VCT220 weight loss clinical trial data also carry implications beyond China. In December 2024, Corxel Pharmaceuticals acquired worldwide ex-Greater China development and commercialization rights to VCT220, which it is advancing under the program name CX11. Corxel is currently evaluating CX11 in a Phase II obesity trial in the US and a Phase II global type 2 diabetes trial. A US Phase II readout is expected later in 2026, which will provide the first look at how the molecule performs outside the Chinese patient population and under regulatory conditions relevant to FDA review.

Vincentage has also indicated it is expanding VCT220's development into type 2 diabetes, hypertension, and other cardiometabolic conditions. Blood pressure improvements were observed across the Phase II and Phase III programs, and hypertension trials have already been initiated, according to the company.

Vincentage plans to submit a New Drug Application to China's National Medical Products Administration for VCT220 in weight management in the near term, with the Corxel-led US Phase II data readout for CX11 expected to follow later in 2026.


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