Corxel Pharmaceuticals, a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients living with cardiometabolic conditions around the world, has 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, Corxel plans to advance into pivotal global phase 3 studies of CX11 in weight management.
The phase 2 trial 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 randomised 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 US 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 favourable gastrointestinal (GI) tolerability and safety profile. Nausea rates ranged from 33-34%, vomiting from 12-16%, diarrhoea 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, diarrhoea, 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 favourable 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.
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.
