Glucagon/GLP-1 dual receptor agonist bests 1 mg semaglutide for weight loss: Phase 2 trial
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SAN DIEGO — A weekly glucagon/GLP-1 dual receptor agonist conferred greater weight loss than 1 mg semaglutide at 16 weeks among adults with type 2 diabetes, according to findings from a phase 2 trial.
In data presented at ObesityWeek 2022, adults with type 2 diabetes randomly assigned to at least 1.2 mg per week of BI 456906 (Boehringer Ingelheim) had greater reductions in HbA1c, weight loss and waist circumference compared with adults receiving semaglutide (Wegovy, Novo Nordisk), and the benefits for those receiving BI 456906 were greater for those taking a higher dose.
“This dual glucagon and GLP-1 receptor agonist induced greater body weight loss than open-label semaglutide after 16 weeks, with a reduction of 8.95% with the highest dose of 3.6 mg vs. 5.4% with semaglutide 1 mg,” Julio Rosenstock, MD, FACE, director of the Dallas Diabetes Research Center at Medical City Dallas and clinical professor of medicine at the University of Texas Southwestern Medical Center, said during a presentation. “The waist circumference [reduction] with the higher dose was about 13 cm. Also, it was a clear there was a robust reduction of HbA1c.”
Researchers conducted a randomized, placebo-controlled trial in which 411 adults with type 2 diabetes for at least 6 months with an HbA1c of 7% to 10%, a BMI of 25 kg/m2 or higher and stable metformin therapy of at least 1,000 mg per day were assigned to one of eight trial arms (56.7% men; mean age, 57.3 years). In six of the arms, participants received BI 456906 of varying doses: 0.3 mg weekly, 0.9 mg weekly, 1.8 mg weekly, 2.7 mg weekly, 1.2 mg twice a week or 1.8 mg twice a week. In a seventh arm, participants were randomly assigned to semaglutide 1 mg weekly. Participants in the eighth arm received placebo. Change in HbA1c, body weight and waist circumference from baseline to 16 weeks were analyzed. Researchers also examined the percentage of adults in each group who lost 5% or more body weight and 10% or more body weight at 16 weeks.
At 16 weeks, every BI 456906 group except for the 0.3 mg weekly arm had a greater absolute reduction in HbA1c than the semaglutide arm, with the greatest reduction seen in the 1.8 mg twice-weekly arm. Similarly, four of the six BI 456906 arms had a greater reduction in body weight at 16 weeks than semaglutide, with the 1.8 mg twice-weekly arm having the largest reduction at 8.95%. Every BI 456906 group except for the 0.3 mg weekly arm had a greater reduction in waist circumference than those taking semaglutide, with the 1.8 mg twice-weekly group again having the largest reduction at 12.89 cm.
Among the 1.8 mg twice-weekly group, 57.1% lost at least 5% of their body weight and 34.7% lost at least 10% of their body weight at 16 weeks.
“Body weight reductions increased dose-dependently, as it has been shown in other GLP-1 receptor agonists and other compounds,” Rosenstock said. “Clearly, the higher dose of 3.6 mg [per week] had the greatest percentage of 5% and 10% weight loss.”
Adverse events were mostly mild in nature, with the most common being nausea, vomiting and diarrhea, according to Rosenstock. Series adverse events were reported in 11 participants across all of the BI 456906 groups.
“The majority of the gastrointestinal adverse events leading to treatment discontinuation were possibly dose- and titration-related,” Rosenstock said. “Slower dose exculpation may mitigate the occurrence of gastrointestinal adverse events.”
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Rosenstock J, et al. O-063. Presented at: ObesityWeek; Nov. 1-4, 2022; San Diego.
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