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Sun Pharmaceutical Industries Ltd. announced results from two phase 1 studies evaluating the tolerability, safety, pharmacokinetics and pharmacodynamics of GL0034, a novel long-acting GLP-1 receptor agonist, in non-obese and obese adults without diabetes. The data highlighted in poster presentations at the American Diabetes Association’s (ADA) 83rd Scientific Sessions held from June 23-26, 2023, in San Diego, California.
In one of the studies, GL0034 reduced triglyceride levels and body weight by Day 8 after a single dose in obese individuals without diabetes. In the other study, GL0034 administered at multiple- ascending doses once weekly for up to 8 weeks was well tolerated and resulted in meaningful pharmacodynamic effects in healthy individuals with normal body weight. In this study, marked dose dependent reductions in body weight of up to -10.7% were observed following GL0034 treatment of relatively low doses for 4 to 8 weeks. Across the two phase 1 studies, the most common adverse events occurring (=5 participants in any dose arm) included nausea, vomiting, decreased appetite, early satiety, and dyspepsia.
“The results of the phase 1 trial of GL0034 are promising based on the safety and efficacy profile,” said Richard E. Pratley, MD, medical director, AdventHealth Diabetes Institute and Senior Investigator, Diabetes Programme Lead, Translational Research Institute. “GL0034 has a promising future in terms of weight loss and glycaemic effects and based on these early results presented at ADA, GL0034 has a potential to be best in class. I look forward to learning more through further studies.”
“The rising incidence of obesity and diabetes places significant burden on global healthcare systems, and GLP-1 agonists have emerged as a useful option for treating these conditions with a single agent. We believe the phase 1 data of Sun’s GL0034 potentially differentiates it from approved therapies in its class. We are excited to take the product through to the next stage of development,” said Dilip Shanghvi, managing director, Sun Pharma.
GL0034 was discovered and is being developed by Sun Pharma. Further clinical studies are planned to confirm clinical safety and efficacy, including a 12-week proof of concept study in obese adults with type 2 diabetes, with non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) biomarkers, which will begin enrollment during 2023.
“These phase 1 studies suggest a potential role for GL0034 as a unique candidate to provide therapeutic benefits for obese adults,” said Rajamannar Thennati, MD, lead investigator and executive vice president, research & development, Sun Pharma. “Initial results showed that GL0034 was generally well tolerated, and we are encouraged by the rate and durability of weight loss in these populations and look forward to proceeding to phase 2 trials in obesity and type 2 diabetes.”
GL0034 (utreglutide) is an investigational novel glucagon-like peptide 1 receptor agonist (GLP- 1RA) in development as a once-weekly, long-acting, antidiabetic medication in patients with obesity and type 2 diabetes. Sun Pharma proceeded into its first-in-human Phase 1 clinical trial based on positive results of its pre-clinical trials in which GL0034 demonstrated robust antidiabetic effects in mice, including reductions in blood glucose levels as well as body weight. Further clinical studies are planned to confirm clinical safety and effectiveness, including a 12-week proof of concept study in obese adults with type 2 diabetes, with non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) biomarkers.
Sun Pharma is the world’s fourth largest specialty generics company with presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as global emerging markets.
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