CORXEL Announces First Patient Enrolled in the U.S. Phase 2 Trial of CX11 in Obese and Overweight Patients
- The U.S. Phase 2 trial is designed to assess the efficacy and safety profile of CX11 in individuals with obesity and overweight.
- Patients will receive doses of CX11 up to 200 mg once-daily over 36 weeks and will be further monitored over a 2-week observation period.
- Topline data from this trial is expected to be released in the first half of 2026.
NEW JERSEY/SHANGHAI, June 17, 2025 – Corxel Pharmaceuticals Limited (CORXEL), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world, announced the enrollment of the first patient in its U.S. Phase 2 trial of CX11. CX11 is an investigational oral once-daily small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA). The U.S. Phase 2 trial is a randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of CX11 in a U.S. population with obesity and overweight.
In a previous Phase 2 trial conducted by Chengdu Vincentage Pharma Co., Ltd. (Vincentage), CX11 demonstrated competitive weight loss with favorable safety and tolerability in Chinese patients.
The U.S. Phase 2 trial is aiming to enroll 250 patients, including those with a BMI greater than or equal to 30 kg/m² or a BMI greater than or equal to 27 kg/m² with at least one weight-related comorbidity. The trial is designed with an optimized titration scheme in an effort to minimize GI side effects. The trial will also evaluate a 200 mg dose of CX11 with the goal of achieving better weight reduction results.
“We are excited to initiate the U.S. Phase 2 trial of CX11 as an important step in our global development plan for establishing CX11 as a potentially transformative treatment option for obese and overweight patients”, said Bo Liang, Senior Vice President, Head of Clinical Development – Metabolic at CORXEL. “We believe that CX11 could potentially become a leading oral treatment solution for patients globally.”
Additional information
CX11’s U.S. Phase 2 clinical trial is a randomized, double-blind, placebo-controlled trial, designed to assess the efficacy and safety profile of CX11 in individuals with obesity and overweight. The trial is aiming to enroll 250 patients, including those with a BMI greater than or equal to 30 kg/m² or a BMI greater than or equal to 27 kg/m² with at least one weight-related comorbidity. The trial will feature five treatment arms: four active treatment groups receiving doses of CX11 of 120 mg, 160 mg, 200 mg with fast titration, and 200 mg with slow titration, respectively, as well as a placebo group. Patients will receive treatment for 36 weeks and will be further monitored over a 2-week observation period. Topline data from this trial is expected to be released in the first half of 2026.
CX11 is an investigational oral small molecule GLP-1 RA designed to address cardiometabolic conditions, with a primary focus on obese and overweight patients. With global ex-China rights acquired by CORXEL from Vincentage in December 2024, CX11 aims to overcome limitations of current injectable GLP-1 RAs by offering convenient, once-daily oral administration, and weight reduction comparable to injectable GLP-1 RAs. CX11 presents favorable tolerability results, scalability and accessibility as a small molecule product candidate. Clinical data from Vincentage’s Phase 2 trial in China demonstrated competitive weight loss with a favorable safety and tolerability profile. CX11 is currently advancing into a U.S. Phase 2 trial conducted by CORXEL and through a Phase 3 registrational trial in China conducted by Vincentage, positioning it as a potentially leading oral therapy for management of obesity and overweight.
CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world. CORXEL is led by an experienced management team that has a strong track record of identifying, in-licensing and developing attractive clinical product candidates directed at validated targets with proven mechanisms of action (MoAs). CORXEL’s diverse portfolio of clinical-stage product candidates has the potential to redefine treatment standards and address key limitations of current therapies for multiple cardiometabolic indications. CORXEL is developing selective small molecule compounds across the cardiometabolic spectrum with the lead product candidate CX11, an oral GLP-1 receptor agonist (GLP-1 RA) for obese and overweight patients, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke (AIS) and JX09, a highly selective aldosterone synthase inhibitor (ASI) for hypertension.
For further information about CORXEL, please visit www.corxelbio.com
