Corxel Pharmaceuticals’ oral obesity candidate has succeeded in a Phase II trial in the US, teeing it up for a pivotal trial.
The New Jersey-based biopharmaceutical company said that in the Phase II trial (NCT07011797), CX11 – a oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1RA), led to up to 11.5% weight loss among obese American patients, with weight loss continuing at a consistent rate and no evidence of a slowing trajectory.
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The study 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, with patients randomised to receive CX11 120 mg, 160mg, 200mg (slow titration), 200mg (fast titration) or placebo once daily for 36 weeks.
Throughout the 36-week double-blind treatment period, CX11 demonstrated a favourable gastrointestinal (GI) tolerability and safety profile.
The drug also showed benefit in a Phase III trial in China, which was run by Corxel’s regional partner Vincentage Pharma. Corxel now plans to advance the candidate into pivotal global Phase III studies of CX11 in weight management.
Dr Bo Liang, CMO of Corxel, said: “We are delighted with these positive US Phase II results, which are consistent with the competitive profile established in the China Phase III programme. 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.”
The oral obesity space is taking shape, with GLP-1RA leaders Novo Nordisk and Eli Lilly each having launched their respective oral drugs, Wegovy (semaglutide) and Foundayo (orfiglipron), in 2026.
There are numerous other oral candidates at varying stages of development, including AstraZeneca’s elecoglipron, which showed 10.5% weight loss in a Phase II trial after 26 weeks. Structure Therapeutics is also investigating a late-stage oral GLP-1RA.
According to GlobalData’s Pharmaceutical Intelligence Center, the total GLP-1RA pill market is forecast to increase from $3.2bn in 2025 to $34.3bn in 2031, representing a compound annual growth rate (CAGR) of 48.4% over the period. Total pill revenues are estimated to represent a fifth of total GLP-1RA drug sales (pill + injectables) by 2031.
GlobalData is the parent company of Clinical Trials Arena.
