India-headquartered Sun Pharmaceutical Industries has announced significant weight loss and lipid level reductions in a study evaluating its investigational drug candidate GL0034 (Utreglutide).
Data from the study was presented at the American Diabetes Association’s 84th Scientific Sessions meeting taking place in Florida from 21–24 June.
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GL0034 is a novel differentiated incretin analogue with long-acting agonist activity at the glucagon-like peptide-1 receptor (GLP-1).
The study was conducted in Belgium and enrolled 24 volunteers with a body mass index (BMI) above 28kg.
Volunteers were split into a fixed (4 x 680 µg) or increasing dose cohort (680/900/1520/2000 µg) and received four weekly doses of GL0034 or a placebo.
Significant body weight reduction was observed from baseline at Day 29, persisting through Day 43 in both treatment cohorts, with absolute weight loss change of -4.6 ± 1.5 (P<0.001) in cohort two.
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By GlobalDataGL0034 also reduced HbA1c, leptin levels, and lipid levels (triglycerides, total cholesterol, non-HDL cholesterol) in each treatment cohort.
Volunteers in each cohort showed significant reductions in glucose AUC0-120 min during oral glucose tolerace tests (OGTT) on Day 23 and dose-dependent insulin AUC0-120 min reductions, which Sun Pharma said suggested improved insulin sensitivity.
Overall, GL0034 was found to be well-tolerated with no treatment-related discontinuations in either cohort.
Executive vice-president of research & development at Sun Pharma, Rajamannar Thennati, said the weight loss and metabolic improvements observed with GL0034 support the need for further clinical evaluation of the drug for the treatment of obesity, type 2 diabetes, metabolic dysfunction-associated steatohepatitis and other weight-related comorbidities.
“To confirm these benefits, we will conduct larger, randomised controlled studies to fully elucidate the therapeutic potential of GL0034 for patients,” Thennati said.
The obesity treatment space is continuing to heat up, with the market forecast to surpass a value of $37bn by 2031, according to GlobalData’s Obesity: Seven-Market Drug Forecast and Market Analysis report.
GlobalData is the parent company of Clinical Trials Arena.
Danish company Novo Nordisk recently reported DKr61bn ($8.7bn) in sales from its diabetes and obesity portfolio, accounting for 93.3% of its total sales in the first quarter of 2024.
Elsewhere in weight loss, Zealand Pharma recently stated its belief that its weight loss drug petrelintide could be comparable with GLP1 receptor agonists while providing a better experience following a Phase Ib trial readout.
On 24 June, Sun Pharma announced the completion of the merger of Taro Pharmaceutical Industries with its subsidiary, having been the majority shareholder in Taro since 2010. Under the deal’s terms, Sun Pharma acquired all outstanding ordinary shares of Taro. Consequently, Taro is now a private company and one wholly owned by Sun Pharma.
