- Elecoglipron demonstrated a favorable safety and tolerability profile in Chinese adults living with obesity/overweight with or without type 2 diabetes mellitus (T2DM), consistent with that of the GLP-1 receptor agonist class
- Pharmacokinetic results in this study were comparable with the prior data generated from global Phase 1 clinical studies, supporting potential use of a consistent dosing regimen for future studies with Chinese participants
SHANGHAI & BOSTON–(BUSINESS WIRE)–Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions, today announced positive topline results from the first Phase 1b clinical trial in China evaluating elecoglipron (AZD5004/ECC5004) in adults living with obesity or overweight, with or without type 2 diabetes mellitus (T2DM).
The results demonstrated a safety and tolerability profile consistent with the GLP-1 receptor agonist (GLP-1RA) class. Exploratory pharmacodynamic (PD) activity characterized by clinically meaningful reductions in body weight among adults with obesity or overweight regardless of T2DM status, as well as meaningful glycemic improvements in patients with T2DM were observed. This study supports the future development of elecoglipron, whereby China could be incorporated into the global Phase 3 program pending relevant regulatory approval.
“The completion of this Phase 1b trial represents an important step forward for elecoglipron’s development in China supported by the seamless collaboration between AstraZeneca and Eccogene,” said Jingye Zhou, Chief Executive Officer of Eccogene. “The results demonstrate that elecoglipron is generally well tolerated, with confirmed target engagement and a PK profile of once-daily dosing in a Chinese population. The advancement of elecoglipron towards global Phase 3 development marks Eccogene’s strength in discovering and developing new therapies for cardiometabolic diseases.”
Sharon Barr, Executive Vice President and Head of BioPharmaceuticals R&D, AstraZeneca, said, “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 to deliver clinically meaningful results, supporting our decision to progress into Phase 3 development.”
Phase 1b Study Results
The randomized, double-blind, placebo-controlled Phase 1b study investigated the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of elecoglipron administered once daily for 16 weeks in 45 adult Chinese participants who are living with obesity or overweight, with or without T2DM. Participants followed a dose titration schedule leading to a targeted maintenance dose over a total treatment period of 16 weeks.
- Safety and Tolerability: Elecoglipron was generally well-tolerated, with a safety profile consistent with the GLP-1RA class. Most adverse events were mild-to-moderate in severity, with the most common being gastrointestinal-related, such as nausea and vomiting. No treatment-emergent adverse events (TEAEs) led to treatment discontinuation. No liver safety signals were observed.
- Pharmacokinetics: The PK profile of elecoglipron 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 the subsequent global clinical development.
- Cohort A (obesity/overweight without T2DM): Compared with the placebo group, participants treated with elecoglipron achieved a clinically meaningful weight reduction at week 16.
- Cohort B (obesity/overweight + T2DM): Participants in this cohort who received elecoglipron achieved a clinically meaningful reduction in mean HbA1c at week 16 compared with those who received placebo.
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), which evaluated elecoglipron in a global patient population of adults living with obesity or overweight with at least one comorbidity, and type 2 diabetes, respectively. 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’s participation in the upcoming global Phase 3 clinical development program for elecoglipron.
About Elecoglipron
Elecoglipron is an investigational oral, small-molecule GLP-1 receptor agonist discovered by Eccogene. It 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.
About Eccogene
Eccogene is a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions. The Company’s diverse pipeline leverages deep expertise in translational research and small molecule drug discovery to address high-impact diseases with significant unmet need. For more information, please visit www.eccogene.com or follow the company on LinkedIn.
Contacts
