Novel GLP-1 RA for weight management clears phase 2 study

The investigational oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA) elecoglipron yields meaningful weight reductions with a safety profile consistent with the drug class, according to a phase 2 dose-ranging study.

The study included 310 adults (mean age 48.4 years, 73 percent female, mean BMI 38.2 kg/m²) with obesity or overweight and at least one weight-related condition and without type 2 diabetes. These participants were randomly assigned to receive elecoglipron at 5 mg (n=32), 15 mg (n=49), 50 mg (every 4-week titration; n=50), 75 mg (weekly titration; n=49), or 75 mg (every 2-week titration; n=49) or matching placebo (n=81). Treatment was administered orally for 36 weeks.

The dual primary endpoints were percent change in bodyweight from baseline and the percentage of patients achieving ≥5-percent weight loss at week 26. Safety and tolerability were evaluated.

At week 26, mean bodyweight decreased by 2.6 percent with 5-mg elecoglipron and by 10.5 percent with the 75-mg dose with weekly titration steps as opposed to only 0.6 percent with placebo. The estimated percentage of participants achieving weight reductions of ≥5 percent ranged from 40.4 percent to 88.8 percent with elecoglipron vs 15.6 percent with placebo.

Adverse events (AEs) occurred in 84 percent to 98 percent of participants across elecoglipron doses and in 84 percent in the placebo group. The most common AEs were nausea, constipation, diarrhoea, headache, and vomiting.