Verdiva Bio has completed enrolment for its phase 2b EVOLVE‑2 clinical study of VRB‑101, a once‑weekly oral GLP‑1 peptide analog being developed for body‑weight reduction in people with overweight or obesity.
The clinical‑stage biopharmaceutical company, which focuses on therapies for obesity and cardiometabolic disorders, said more than 200 participants have been enrolled across 22 US sites.
Topline results are expected by the end of 2026.
EVOLVE‑2 is a randomised, double‑blind, placebo‑controlled phase 2b trial evaluating the safety, tolerability and efficacy of VRB‑101. Participants include adults with obesity or those who are overweight with at least one weight‑related comorbidity.
The study includes five active arms and one placebo arm, with once‑weekly oral dosing over 20 weeks.
Its primary endpoint is mean percentage body‑weight change from baseline.
The trial is designed to guide optimal starting and maintenance doses, as well as the titration schedule, for future studies. Assuming positive results, Verdiva Bio expects to begin phase 3 trials in 2027.
Dr Mohamed Eid, CMO at Verdiva Bio, said: “Obesity is a multifactorial chronic disease with important health-related complications requiring long-term therapy.”
He added: “Previous studies indicate a promising clinical profile for VRB-101, supported by PK modelling which suggest VRB-101’s ability to achieve drug levels similar to or higher than a once-weekly injectable GLP-1 peptide currently approved in the US and other major markets.
“VRB-101 appears to have the potential to become a first-in-class once-weekly oral GLP-1 analog for people living with obesity or overweight and weight-related complications.”
VRB‑101 is an oral formulation of ecnoglutide, a cAMP‑biased GLP‑1 peptide analog delivered using the company’s proprietary oral technology.
Phase 1 PK modelling suggests drug levels comparable to, or exceeding, those of once‑weekly injectable semaglutide. VRB‑101 is also being studied in combination with Verdiva Bio’s potential once‑weekly oral amylin analog, VRB‑103.
