Corxel Pharmaceuticals has received investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for the randomised US Phase II trial of oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA) CX11 for obesity treatment.
This placebo-controlled, double-blind trial will assess the safety and efficacy of this one-time-a-day therapy in individuals with obesity and overweight conditions in the US.
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Corxel anticipates commencing enrollment in the second quarter of this year, with topline data expected in the first half of 2026.
The trial aims to enrol 250 subjects, targeting individuals with a body mass index (BMI) of ≥30kg/m² or of ≥27kg/m² with a minimum of one weight-related comorbidity.
Subjects will undergo treatment for more than 36 weeks, followed by a two-week monitoring period.
The trial is set to involve five treatment arms, one placebo group, and four groups that will receive active doses of CX11 at varying levels: 120mg, 160mg, and 200mg with two different titration speeds, one faster and one slower.
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By GlobalDataPositive outcomes could lead to a global Phase III development.
Corxel Pharmaceuticals Metabolic – Clinical Development head and senior vice-president Bo Liang said: “We are excited to receive the Study May Proceed Letter from the FDA for the US Phase II trial of CX11, a critical milestone in our mission to address the global burden of obesity and related cardiometabolic diseases.
“Currently approved GLP-1 therapies, while generally effective, often face obstacles such as weekly injections, titration difficulty, side effects and limited tolerability, maintaining weight loss and supply challenges for peptide-based therapies. With once-daily oral administration and promising clinical data, CX11 aims to address these issues, potentially offering a best-in-class convenient oral treatment solution for patients globally.”
Also referred to as VCT220, CX11 was previously claimed to have demonstrated competitive weight loss results with favourable tolerability and safety in a Phase II trial carried out by Suzhou Vincentage Pharma in China.
The company acquired worldwide rights to the therapy, excluding China from Vincentage in last December.
