CORXEL Pharmaceuticals reported positive Phase 2 results for oral GLP-1 receptor agonist CX11, with patients achieving up to 11.5% weight loss after 36 weeks of treatment.

CORXEL Pharmaceuticals has reported positive top-line results from a US Phase 2 clinical trial evaluating CX11, an oral small-molecule GLP-1 receptor agonist, in adults with obesity or overweight and at least one weight-related comorbidity.

The study met its primary endpoints, with participants achieving up to 11.5% weight loss after 36 weeks of treatment. According to the company, weight reduction continued at a consistent rate throughout the study period, with no evidence of a slowing trajectory.

The randomised trial enrolled 246 adults with obesity, defined as a body mass index (BMI) of at least 30 kg/m², or overweight participants with a BMI between 27 kg/m² and 30 kg/m² and at least one weight-related comorbidity.

Participants were assigned to receive one of four CX11 dosing regimens or placebo once daily for 36 weeks.

Obesity remains one of the fastest-growing therapeutic areas globally, with increasing interest in oral alternatives to injectable GLP-1 therapies. While injectable medicines have demonstrated significant efficacy, barriers including administration requirements, tolerability concerns and treatment adherence continue to drive development of oral options.

CORXEL reported that CX11 demonstrated a favourable gastrointestinal safety profile during the study. Nausea rates ranged from 33% to 34% across treatment groups, while vomiting rates ranged from 12% to 16%. Diarrhoea was reported in 4% to 12% of participants and constipation in 2% to 12%.

Most gastrointestinal adverse events were reported as mild to moderate and occurred during dose escalation before declining during the maintenance phase of treatment.

The overall treatment discontinuation rate due to gastrointestinal adverse events was 5%.

The company also reported no hepatic safety signal in the Phase 2 study. More than 1,500 participants have now received CX11 across clinical studies, with no liver safety concerns identified to date.

Dr Bo Liang, chief medical officer at CORXEL Pharmaceuticals, said: “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. 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 company said it plans to advance CX11 into global Phase 3 studies for weight management following the Phase 2 results and recently reported Phase 3 obesity data from China generated by development partner Vincentage Pharma.