Ji Xing Announces First Patient Dosed in U.S. Phase 2 Clinical Trial of CX11 for Obesity and Overweight

June 17, 2025, New Jersey, USA / Shanghai, China – CORXEL (hereinafter referred to as “CORXEL”), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiovascular and metabolic diseases worldwide, today announced that the first patient has been enrolled in its Phase 2 clinical trial of CX11 for the treatment of obesity and overweight in the United States. CX11 is an investigational once-daily oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA). This randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of CX11 in treating patients with obesity and overweight in the United States.

Previous Phase 2 clinical trial results of CX11 conducted by Chengdu Wentai Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Wentai Pharmaceutical”) in China demonstrated competitive weight-loss efficacy, along with a favorable safety and tolerability profile, in Chinese patients.

The Phase 2 trial in the United States plans to enroll 250 patients with a body mass index (BMI) ≥30 kg/m², or BMI ≥27 kg/m² with at least one weight-related comorbidity. The trial incorporates an optimized dose-titration regimen designed to minimize gastrointestinal adverse events while evaluating the efficacy of a higher 200-mg dose of CX11 to achieve superior weight-loss outcomes.

Dr. Liang Bo

Senior Vice President, Clinical Development, Metabolism, CORXEL

“CX11 has the potential to transform the treatment landscape for patients with obesity and overweight globally, making the initiation of this U.S. Phase 2 clinical trial an exciting milestone and a key component of CX11’s global development strategy. We believe CX11 has the potential to become a leading oral therapy for the treatment of obesity and overweight worldwide.”

The CX11 U.S. Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of the drug in patients with obesity or overweight in the United States. The trial plans to enroll 250 patients, including those with a body mass index (BMI) ≥30 kg/m², or a BMI ≥27 kg/m² with at least one weight-related comorbidity. The study will include five treatment arms: a placebo group and four active groups receiving 120 mg, 160 mg, 200 mg with rapid titration, and 200 mg with slow titration, respectively. Patients will undergo 36 weeks of treatment followed by a 2-week follow-up period. Top-line data are expected to be announced in the first half of 2026.

CX11 is an investigational oral small-molecule GLP-1 receptor agonist targeting cardiometabolic diseases, primarily indicated for the treatment of obesity and overweight. In December 2024, CORXEL acquired the global rights to CX11, excluding China, from Wentai Pharmaceuticals. With efficacy comparable to injectable GLP-1 RAs, CX11 has the potential to overcome the clinical limitations of current injectable therapies by offering a more convenient once-daily oral dosing regimen, better tolerability, and the superior scalability and accessibility inherent to small-molecule drugs. Phase 2 clinical trial data conducted in China by Wentai Pharmaceuticals have already demonstrated competitive weight-loss efficacy along with a favorable safety and tolerability profile. Currently, the U.S. Phase 2 trial sponsored by CORXEL and the registrational Phase 3 clinical trial in China conducted by Wentai Pharmaceuticals are both underway, positioning CX11 to become a leading global oral therapy for obesity and overweight.

CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiovascular diseases worldwide. The company’s management team possesses extensive experience and a proven track record in identifying, licensing, and developing high-quality clinical candidates targeting validated targets with well-defined mechanisms of action (MoA). CORXEL’s diversified pipeline of clinical-stage assets has the potential to redefine standards of care by addressing key limitations of current therapies for various cardiometabolic disorders. The company is developing a curated portfolio of small-molecule compounds spanning the cardiometabolic disease area, with core products including CX11, an oral GLP-1 receptor agonist for the treatment of obesity and overweight; JX10, a novel thrombolytic agent with anti-inflammatory properties for the treatment of acute ischemic stroke (AIS); and JX09, a highly selective aldosterone synthase inhibitor (ASI) for the treatment of hypertension.