- Individuals receiving CX11 (also known as VCT220) in the 160 mg fast and slow titration groups experienced body weight reductions of 9.7% and 9.4% from their initial weight after 16 weeks, respectively (p≤0.001).
- The findings indicate a positive tolerability profile, with no instances of drug-induced liver damage reported.
BERKELEY HEIGHTS, N.J. and SHANGHAI, June 23, 2025 — Corxel Pharmaceuticals Limited (CORXEL), a biopharmaceutical firm focused on global cardiometabolic treatments, announced with partner Chengdu Vincentage Pharma Co., Ltd. (Vincentage) the positive results from the China Phase 2 clinical trial of its oral, once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) CX11/VCT220. These findings were presented as a poster at the 85th Scientific Sessions of the American Diabetes Association (ADA). The abstract is also slated for online publication on the Diabetes® journal’s website.
Vincentage carried out the randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the effectiveness, safety, and tolerability of CX11/VCT220 in non-diabetic adults in China who were categorized as obese or overweight.
The Chinese Phase 2 study enrolled 250 adult participants with a Body Mass Index (BMI) of at least 28 kg/m2, or between 24 kg/m2 and 28 kg/m2 with at least one obesity-related co-existing condition. Participants were randomly assigned in a 3:1 ratio to receive CX11/VCT220 (at 80 mg, 120 mg, or 160 mg doses) or a corresponding placebo. The 160 mg group was then split equally (1:1) into fast or slow titration subgroups. The main goal of the study was to measure the percentage change in body weight (BW) from baseline to week 16.
Summary of Findings:
Initially, the average body weight was 91.76 kg, and the average BMI was 32.03 kg/m2, with 93.6% of participants having a BMI of 28 kg/m2 or higher. By week 16, the average percentage change in body weight from baseline varied from -5.8% to -9.7% across the CX11/VCT220 dosage groups, while the placebo group showed a -1.6% change. Weight loss was considerably more pronounced at all CX11/VCT220 doses compared to the placebo. Between 55% and 90% of participants receiving CX11/VCT220 achieved a weight reduction of at least 5% by week 16, versus 13% in the placebo group. (Refer to Figure). CX11/VCT220 treatment also led to improvements in all evaluated weight-related and cardiometabolic indicators, such as liver enzymes (ALT, AST) and blood pressure. The majority of reported adverse events were gastrointestinal (GI) in nature and were classified as mild to moderate (95.8% severity). No signs of liver toxicity were detected, and no serious adverse events linked to the drug were reported.
The presentation of this data at the ADA represents the initial global showcase of CX11/VCT220’s clinical findings.
“We are gratified by the data presented at ADA, which confirmed CX11/VCT220’s strong efficacy and positive tolerability,” stated Dr. Bo Liang, Senior Vice President and Head of Clinical Development – Metabolic at CORXEL. “Leveraging the robust scientific groundwork established by Vincentage, we commenced the Phase 2 trial for CX11 in the U.S. last week, with the first patient enrolled. We anticipate that the U.S. Phase 2 trial could potentially enhance the weight reduction and tolerability outcomes seen in the China Phase 2 clinical trial of CX11/VCT220.”
“We are thrilled to witness CX11/VCT220 attracting international interest,” expressed Dr. Ben Li, Chief Executive Officer of Vincentage. “The Phase 3 registrational trial in China began in November 2024, and we eagerly anticipate supporting CORXEL in their worldwide development initiatives.”
Concerning CX11
CX11 is an experimental oral small molecule GLP-1 RA developed to treat cardiometabolic disorders, primarily targeting individuals who are obese or overweight. CORXEL obtained global rights (excluding China) from Vincentage in December 2024. CX11 seeks to address the drawbacks of existing injectable GLP-1 RAs by providing easy, once-daily oral dosing and achieving weight loss comparable to injectable GLP-1 RAs. As a small molecule candidate, CX11 exhibits promising tolerability, scalability, and accessibility. Clinical findings from Vincentage’s Phase 2 trial in China showed strong weight loss outcomes alongside a positive safety and tolerability profile. CX11 is now moving forward with a Phase 2 trial in the U.S. led by CORXEL and a Phase 3 registrational trial in China overseen by Vincentage, positioning it as a potentially significant oral treatment for obesity and overweight conditions.
Regarding CORXEL
CORXEL is a biopharmaceutical company in the clinical phase, committed to creating pioneering treatments for patients globally with cardiometabolic conditions. CORXEL is guided by a seasoned management team with a proven history of discovering, acquiring licenses for, and advancing promising clinical product candidates that target well-established pathways with confirmed mechanisms of action (MoAs). CORXEL’s varied pipeline of clinical-stage product candidates holds the potential to transform treatment paradigms and tackle significant deficiencies in current therapies for various cardiometabolic indications. CORXEL is currently developing specialized small molecule compounds for a range of cardiometabolic issues, including its primary candidate CX11, an oral GLP-1 receptor agonist (GLP-1 RA) for obese and overweight individuals; JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke (AIS); and JX09, a highly selective aldosterone synthase inhibitor (ASI) for hypertension.
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