Оральный препарат от ожирения CX11 показал снижение веса на 11,5% в фазе II

A US-based phase 2 trial of an investigational oral GLP-1 called CX11 met all its primary endpoints for weight loss and safety, according to CORXEL Pharmaceuticals, Berkeley Heights, New Jersey, which is developing the drug. At 36 weeks, CX11 achieved up to 11.5% weight loss among patients living with obesity, with weight loss continuing at a consistent rate and no evidence of a slowing trajectory, the company said. The gastrointestinal (GI) tolerability and safety profile were favorable. The multicenter, double-blind, placebo-controlled phase 2 trial enrolled 246 adults with obesity (BMI ≥ 30) or overweight (BMI ≥ 27 to < 30) with at least one weight-related comorbidity. Participants “represented the US obesity and overweight population demographic,” CMO Bo Liang said. Eligibility criteria included, among other factors, an A1c level below 6.5% and fasting blood sugar levels below 126 mg/dL, having tried and failed to lose weight through diet and exercise at least once before the study, and having had a stable body weight (less than a 5% change) in the 90 days before the study. Participants were randomly assigned in a 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. Nausea rates ranged from 33% to 34%, vomiting from 12% to 16%, diarrhea from 4% to 12%, and constipation from 2% to 12% across different dosing cohorts. The most common reported adverse events were GI-related and generally mild-to-moderate in severity. No severe cases of nausea, vomiting, diarrhea, or constipation were reported. GI adverse events mainly occurred during the dose-escalation period and gradually subsided during the maintenance period. The overall treatment discontinuation rate due to these events was 5%. To date, more than 1500 participants have been studied across all CX11 clinical studies, with no hepatic safety signal identified, according to the company. The findings also build on positive top-line results from partner Vincentage Pharma’s pivotal phase 3 trial of the drug, called VCT220 in China, announced in May. Taken together, the results support CX11 as a potentially differentiated oral GLP-1 candidate, designed for once-daily use with no food or water restrictions and no refrigeration or light-protected storage requirements,” the spokesperson said. “CORXEL is planning to discuss the pivotal phase 3 trial design with the FDA/EMA [European Medicines Agency] soon and aiming to start the pivotal trial early next year, according to the company. Marilynn Larkin, MA, is an award-winning medical writer and editor based in New York City whose work has appeared in numerous publications, including Medscape Medical News and its sister publication MDedge, The Lancet (where she was a contributing editor), and Reuters Health.