Sun Pharma's GL0034 Shows Significant Weight Loss, Gluco-metabolic, and Lipid-Lowering Effects in Obesity at ADA 84th Sessions

Sun Pharmaceutical Industries Limited recently presented promising results from a Phase 1 study that evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of GL0034 (Utreglutide) in obese adults. The findings were shared at the 84th Scientific Sessions of the American Diabetes Association (ADA) on June 21, 2024. This investigational GLP-1 receptor agonist demonstrated substantial weight loss and improvements in gluco-metabolic parameters over a four-week treatment period.

The study involved 24 healthy, obese male participants aged 18-40 with a BMI of 28 kg/m² or higher. They were divided into two cohorts: Cohort 1, which received a fixed dose of 4 x 680 µg, and Cohort 2, which had increasing doses of 680/900/1520/2000 µg. Participants were randomly assigned to receive four weekly doses of either GL0034 or a placebo in a 3:1 ratio. An oral glucose tolerance test (OGTT) was performed both at baseline (Day -1) and after the fourth dose (Day 23).

Results showed significant body weight reduction from baseline at Day 29, which persisted through Day 43 in the treatment groups compared to placebo. Specifically, Cohort 2 exhibited an absolute weight loss change of –4.6 ± 1.5, which was statistically significant (P<0.001). Both cohorts demonstrated significant reductions in glucose and insulin levels during the OGTT on Day 23, indicating improved insulin sensitivity. Additional metabolic improvements included reduced levels of HbA1c, leptin, triglycerides, total cholesterol, and non-HDL cholesterol.

GL0034 was well-tolerated with no treatment-related discontinuations. The most common adverse events were gastrointestinal, consistent with those typically observed in the incretin class. These findings suggest that GL0034 has a favorable tolerability profile and holds promise for treating obesity and its associated comorbidities.

Richard E. Pratley, MD, from AdventHealth Diabetes Institute, highlighted the remarkable results, noting the significant weight loss and notable improvements in lipid profiles among obese participants. He emphasized that GL0034 stands out as a differentiated asset in weight management, calling for further research and development to fully understand its therapeutic potential.

Dilip Shanghvi, Managing Director of Sun Pharma, expressed the company's dedication to addressing the global health challenge of obesity. He emphasized that the promising data from the GL0034 study not only demonstrate its efficacy in weight loss but also underscore its potential in improving key cardiometabolic parameters and risk factors.

The Phase 1 study was conducted in Belgium and underscores GL0034's potentially differentiated profile in the evolving landscape of obesity treatment. The results indicate clinically meaningful weight loss, significant metabolic improvements, and a favorable tolerability profile. Notably, GL0034 has shown an ability to lower lipid profiles, particularly triglycerides, suggesting an additional therapeutic benefit that sets it apart from other treatments.

Rajamannar Thennati, MD, Lead Investigator and Executive Vice President of Research & Development at Sun Pharma, indicated that the significant weight loss and metabolic improvements observed with GL0034 support its further clinical evaluation. Larger, randomized controlled studies are planned to confirm these benefits and fully elucidate the therapeutic potential of GL0034 for treating obesity, type 2 diabetes, metabolic dysfunction-associated steatohepatitis, and other weight-related conditions.