Eccogene Reports Positive Phase 1b Results for Oral GLP-1 Agonist Elecoglipron in Chinese Patients with Obesity
Key Insights
Elecoglipron (search) demonstrated a favorable safety and tolerability profile consistent with the GLP-1 receptor agonist class in 45 Chinese adults with obesity or overweight conditions.
The oral small-molecule drug achieved clinically meaningful weight reduction in participants without diabetes and significant HbA1c improvements in those with type 2 diabetes.
Pharmacokinetic results were comparable to global Phase 1 studies, supporting consistent dosing regimens for future Chinese participants in the global Phase 3 program.
Eccogene (search) announced positive topline results from its first Phase 1b clinical trial in China evaluating elecoglipron (search) (AZD5004/ECC5004), an investigational oral GLP-1 receptor agonist, in adults living with obesity or overweight conditions with or without type 2 diabetes mellitus. The results demonstrated a safety profile consistent with the GLP-1 receptor agonist class and showed clinically meaningful reductions in body weight and glycemic improvements.
Study Design and Patient Population
The randomized, double-blind, placebo-controlled Phase 1b study investigated the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of elecoglipron (search) administered once daily for 16 weeks in 45 adult Chinese participants. The study population included individuals living with obesity or overweight, with or without type 2 diabetes mellitus. Participants followed a dose titration schedule leading to a targeted maintenance dose over the 16-week treatment period.
Safety and Efficacy Results
Elecoglipron (search) was generally well-tolerated, with most adverse events being mild-to-moderate in severity. The most common adverse events were gastrointestinal-related, including nausea and vomiting, which is consistent with the known profile of GLP-1 receptor agonists. Notably, no treatment-emergent adverse events led to treatment discontinuation, and no liver safety signals were observed.
The study was divided into two cohorts based on diabetes status. In Cohort A, which included participants with obesity or overweight without type 2 diabetes, those treated with elecoglipron (search) achieved clinically meaningful weight reduction at week 16 compared with the placebo group. In Cohort B, participants with obesity or overweight plus type 2 diabetes who received elecoglipron achieved a clinically meaningful reduction in mean HbA1c at week 16 compared with those who received placebo.
Pharmacokinetic Profile Supports Global Development
The pharmacokinetic profile of elecoglipron (search) in Chinese participants was similar to prior data generated from global clinical studies. These results support the potential use of consistent dose levels and dosing regimen for Chinese participants in subsequent global clinical development, facilitating China's integration into the worldwide Phase 3 program.
"The results demonstrate that elecoglipron (search) is generally well tolerated, with confirmed target engagement and a PK profile of once-daily dosing in a Chinese population," said Jingye Zhou, Chief Executive Officer of Eccogene (search). "The advancement of elecoglipron towards global Phase 3 development marks Eccogene's strength in discovering and developing new therapies for cardiometabolic diseases."
Integration with Global Development Program
The completion of this Phase 1b trial in China coincides with the conclusion of AstraZeneca's two global Phase 2b multicenter trials, VISTA (NCT06579092) and SOLSTICE (NCT06579105). These trials evaluated elecoglipron (search) in a global patient population of adults living with obesity or overweight with at least one comorbidity, and type 2 diabetes, respectively.
Sharon Barr, Executive Vice President and Head of BioPharmaceuticals R&D at AstraZeneca, commented, "Obesity is a disease that affects billions worldwide and we need effective and convenient treatments that can reduce the burden of this chronic disease. The Phase 1b results, together with the Phase 2b data show the potential of elecoglipron (search) to deliver clinically meaningful results, supporting our decision to progress into Phase 3 development."
Drug Profile and Partnership
Elecoglipron (search) is an investigational oral, small-molecule GLP-1 receptor agonist discovered by Eccogene (search). The drug is designed to offer a convenient once-daily dosing regimen with no food-related restrictions, which may help support patient adherence and broaden access. In November 2023, Eccogene entered into a global licensing agreement with AstraZeneca for elecoglipron, while retaining co-development and co-commercialization rights in China.
The positive data from this Phase 1b study in China, combined with the comprehensive results from the global Phase 2b program, provide an integrated clinical foundation to support Eccogene (search)'s participation in the upcoming global Phase 3 clinical development program for elecoglipron (search).