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Obesity Treatment: Sun Pharma’s GL0034 (Utreglutide) Demonstrates Significant Weight Loss and Metabolic Benefits in ADA Presentation

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Obesity treatment has shown promising results in a Phase 1 multiple ascending-dose study of GL0034 (Utreglutide), a novel GLP-1 receptor agonist, as announced by Sun Pharmaceutical Industries Limited at the 84th Scientific Sessions of the American Diabetes Association (ADA). The study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of GL0034 in obese adults, showcasing its potential as a therapeutic option for individuals with obesity and related metabolic disorders.

GL0034, administered once weekly, confirmed clinically meaningful weight loss and improved glucometabolic parameters over a 4-week treatment period in individuals with obesity, even at the lowest dosing regimen. The drug demonstrated significant gluco-metabolic activity and reductions in lipid levels, including triglycerides, total cholesterol, and non-HDL cholesterol, suggesting novel and beneficial effects on lipid metabolism. Furthermore, GL0034 exhibited a favorable tolerability profile, with gastrointestinal adverse events consistent with those typically observed in the incretin class.

Obesity Study Shows Promising Results with GL0034 in Phase 1 Trial

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

Key findings from the study include significant body weight reduction observed from baseline at Day 29, which persisted through Day 43 in the treatment cohorts compared to the placebo. Cohort 2, which received the highest doses, showed an absolute weight loss change of –4.6 ± 1.5 (P<0.001). Both cohorts exhibited significant reductions in glucose AUC0-120 min during OGTT on Day 23 and dose-dependent insulin AUC0-120 min reductions, indicating improved insulin sensitivity. Additionally, reductions in HbA1c, leptin levels, and lipid levels (triglycerides, total cholesterol, non-HDL cholesterol) were noted in the treatment cohorts.

obesity

Obesity Study Highlights GL0034’s Potential in Weight Management

“The recent GL0034 study has shown encouraging results with significant weight loss and notable improvements in lipid profiles among obese participants,” said Richard E. Pratley, MD, Medical Director at AdventHealth Diabetes Institute. “This investigational therapy stands out as a potentially differentiated asset in the weight management field.”

Dilip Shanghvi, Managing Director of Sun Pharma, emphasized the company’s commitment to addressing the global health challenge of obesity. “The promising data from our GL0034 study highlights our dedication to developing innovative therapies that bring meaningful benefits to patients worldwide.”

The study’s safety profile was favorable, with no treatment-related discontinuations. The most common adverse events were gastrointestinal, aligning with the known profile of the incretin class. Conducted in Belgium, the study provides robust evidence that GL0034 has a potentially differentiated profile in the evolving landscape of obesity treatment. The Phase 1 results demonstrated clinically meaningful weight loss, significant metabolic improvements, and a favorable tolerability profile. Notably, GL0034 has shown a novel ability to lower lipid profiles, especially triglycerides, suggesting an additional therapeutic benefit that sets it apart from other treatments.

As a selective GLP-1 receptor agonist, GL0034 shows potential for enhanced therapeutic benefits. “The significant weight loss and metabolic improvements observed with GL0034 strongly support further clinical evaluation for treating obesity, type 2 diabetes, metabolic dysfunction-associated steatohepatitis, and other weight-related comorbidities,” said Rajamannar Thennati, MD, Lead Investigator and Executive Vice President, Research & Development at Sun Pharma. Larger, randomized controlled studies are planned to fully elucidate the therapeutic potential of GL0034 for patients.

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Resource: SunPharma, June 22, 2024

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