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American Diabetes Association | ADA | 2024 | News | Updates | iPharmaCenter

Sun Pharma’s GL0034 (Utreglutide) Shows Promising Results in Obesity Treatment at ADA Scientific Sessions

Sun Pharmaceutical Industries Limited has announced encouraging results for their obesity treatment drug, GL0034 (Utreglutide), presented at the American Diabetes Association's 84th Scientific Sessions. The once-weekly administered GL0034 has shown to be effective in promoting weight loss and improving metabolic and lipid parameters over a four-week period, even at the lowest dose.

Highlights from the Phase 1 Study

  • Substantial Weight Reduction: GL0034 resulted in notable weight loss in obese individuals.

  • Metabolic Improvement: The drug enhanced glucometabolic functions, lowered glucose levels, and increased insulin sensitivity.

  • Lipid Reduction: GL0034 decreased levels of triglycerides, total cholesterol, and non-HDL cholesterol, indicating beneficial effects on lipid metabolism.

  • Well Tolerated: The drug had a good safety profile, with gastrointestinal side effects similar to those seen with other incretin-based treatments.

Study Overview

The approval for GL0034 comes from a Phase 1, multiple ascending-dose study that examined the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in adults with obesity. The study included 24 healthy, obese male participants aged 18-40 with a BMI of 28 kg/m² or higher. Participants were divided into two cohorts: one received a fixed dose, and the other received increasing doses. Both cohorts received four weekly doses of either GL0034 or a placebo.

Study Results

  • Weight Loss: Significant weight reduction was observed from baseline on Day 29, persisting through Day 43 in the treatment groups compared to the placebo group, with Cohort 2 showing an absolute weight loss change of –4.6 ± 1.5.

  • Insulin Sensitivity: Both cohorts demonstrated significant reductions in glucose AUC0-120 min during the oral glucose tolerance test (OGTT) on Day 23, along with dose-dependent reductions in insulin AUC0-120 min.

  • Lower HbA1c and Leptin Levels: Treatment groups showed reductions in HbA1c, leptin levels, and lipid levels (triglycerides, total cholesterol, non-HDL cholesterol).

  • Safety and Tolerability: GL0034 was generally well tolerated, with no treatment-related discontinuations and gastrointestinal side effects consistent with the incretin class profile.

Implications for Obesity Management

Obesity is a major health challenge worldwide, contributing to various metabolic disorders such as type 2 diabetes, cardiovascular diseases, and metabolic dysfunction-associated steatohepatitis (MASH). Effective treatments are essential for managing obesity and its associated health issues. GLP-1 receptor agonists have shown promise in treating obesity.

GL0034 (Utreglutide), a new incretin analogue, has demonstrated potent, long-lasting activity at the GLP-1 receptor. The Phase 1 study indicates that GL0034 not only supports weight loss but also offers significant metabolic benefits and is well tolerated. The drug's ability to reduce lipid profiles, particularly triglycerides, suggests an additional therapeutic advantage that distinguishes it from other treatments.

These findings suggest that GL0034 could be an effective option for managing obesity, offering comprehensive benefits beyond weight loss to include significant improvements in key metabolic markers. The study results underscore the potential of GL0034 in the treatment of obesity.


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