Sun Pharma’s GL0034 yields promising results in two Phase 1 trials

Sun Pharmaceutical Industries has unveiled positive results from two Phase 1 studies assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of GL0034, a novel long-acting GLP-1 receptor agonist, in non-obese and obese adults without diabetes.

The findings will be presented in poster sessions at the American Diabetes Association’s 83rd Scientific Sessions in San Diego.

One of the studies demonstrated that GL0034 effectively reduced triglyceride levels and body weight within eight days after a single dose in obese individuals without diabetes.

In the other study, GL0034 was administered at increasing doses once weekly for up to eight weeks and was well tolerated, showing meaningful pharmacodynamic effects in healthy individuals with normal body weight.

Marked dose-dependent reductions in body weight of up to -10.7% were observed following GL0034 treatment for four to eight weeks at relatively low doses. Common adverse events included nausea, vomiting, decreased appetite, early satiety, and dyspepsia.

Rajamannar Thennati — Sun Pharma Executive Vice President, Research & Development said: “These Phase 1 studies suggest a potential role for GL0034 as a unique candidate to provide therapeutic benefits for obese adults.

“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.”