Corxel Pharmaceuticals Reports Positive Top-Line Results from Phase 2 Trial of CX11 in Obese and Overweight U.S. Adults
- U.S. Phase 2 trial met primary endpoints, with up to 11.5% weight loss at 36 weeks, showing continued weight reduction at a consistent rate and no evidence of a slowing trajectory
- CX11 demonstrated favorable GI tolerability and safety profile, with a markedly low vomiting rate, ranging from 12-16%
- No hepatic safety signal observed in the U.S. P2 and China P3 studies
Berkeley Heights, NJ, Jun. 23, 2026 – Corxel Pharmaceuticals Limited (“CORXEL”), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients living with cardiometabolic conditions around the world, today announced positive top-line results from its Phase 2 trial evaluating CX11, an oral small molecule GLP-1 receptor agonist (GLP-1 RA), in obese and overweight participants in the United States. Building on these results and the successful China obesity Phase 3 results recently announced by its partner Vincentage Pharma Co., Ltd., CORXEL plans to advance into pivotal global Phase 3 studies of CX11 in weight management.
The Phase 2 trial (NCT07011797) enrolled 246 adults with obesity (BMI ≥30 kg/m²) or who were overweight (27 kg/m² ≤ BMI <30 kg/m²) with at least one weight-related comorbidity in the United States. Participants were randomized 1:1:1:1:1 to receive CX11 120 mg, CX11 160 mg, CX11 200 mg (slow titration), CX11 200 mg (fast titration) or placebo once daily for 36 weeks.
At 36 weeks, CX11 achieved up to 11.5% weight loss among U.S. obesity patients, with weight loss continuing at a consistent rate and no evidence of a slowing trajectory. Throughout the 36-week double-blind treatment period, CX11 demonstrated a favorable gastrointestinal (GI) tolerability and safety profile. Nausea rates ranged from 33-34%, vomiting from 12-16%, diarrhea from 4-12%, and constipation from 2-12% across different dosing cohorts. The most commonly reported adverse events were GI-related and generally mild to moderate in severity. There were no severe cases of nausea, vomiting, diarrhea, or constipation reported in the study. Gastrointestinal adverse events (GI AEs) primarily occurred during the dose escalation period and gradually subsided during the maintenance period. The overall treatment discontinuation rates due to GI AEs was low, at 5.0%. CX11 continued to demonstrate a favorable hepatic safety profile in the study, with no hepatic safety signal observed. To date, more than 1,500 participants have been studied across all CX11 clinical studies, with no hepatic safety signal identified.
“We are delighted with these positive U.S. Phase 2 results, which are consistent with the competitive profile established in the China Phase 3 program,” said Bo Liang, MD, PhD, Chief Medical Officer of CORXEL. “Together, these datasets reinforce our confidence in CX11 and our conviction to offer patients around the world an effective and highly tolerable option with dosing flexibility. As we look forward to advancing into pivotal global Phase 3 studies for CX11, we are also enthusiastic about the potential of our other cardiometabolic programs in development, including CX12, our internally discovered small molecule amylin RA product.”
Cardiometabolic disease remains a leading cause of death, responsible for over 30% of global annual mortality. Medication adherence remains a critical barrier, with studies showing up to 50% of patients with chronic conditions do not take medications as prescribed. Broad adoption of current GLP-1 therapies remains suboptimal due to challenges such as inconvenience of subcutaneous injections, titration difficulty, limited tolerability, and supply constraints.
Additional information
CX11 is an investigational oral small molecule GLP-1 receptor agonist designed to address cardiometabolic conditions, including obesity, overweight and type 2 diabetes. 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 has demonstrated favorable tolerability, scalability, and accessibility as a small molecule product candidate. Clinical data from Vincentage’s Phase 3 trial in China demonstrated competitive weight loss with a favorable safety and tolerability profile. CORXEL plans to advance CX11 into a global Phase 3 clinical trial.
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 small molecule GLP-1 RA under clinical development for obesity and overweight conditions and T2DM, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke and CX12, an oral small molecule amylin RA under pre-clinical development. CORXEL also has additional small molecule programs in development targeting validated obesity targets.
For further information about CORXEL, please visit www.corxelbio.com.