NEW ORLEANS -- Injections of an ultra-long-acting investigational GLP-1 agonist led to significant weight loss in people with overweight or obesity, with reductions continuing after a switch to once-monthly dosing, according to the ongoing VESPER clinical program.
After an initial 12-week titration period with weekly dosing, average body weight with the 4.8-mg monthly dose level of berobenatide declined 12.1% by week 28 -- and without reaching a plateau -- as compared with a 0.2% increase with placebo, interim findings from the dose-finding phase IIb VESPER-3 study showed.
"The transition to monthly dosing was well-tolerated," said John Buse, MD, PhD, of the University of North Carolina School of Medicine at Chapel Hill, at the American Diabetes Association (ADA) annual meeting.
Safety and tolerability were consistent with the GLP-1 receptor agonist class, Buse noted, and the study "is informing the phase III program, where the highest dose will be 9.6 mg monthly -- the 2.4-mg dose from VESPER-1 multiplied by four."
Main results from the phase IIb VESPER-1 trial, presented earlier this year, reported a 16% weight loss by week 32 with 2.4 mg of berobenatide once-weekly. During an extension phase presented at ADA also by Buse, participants who switched from placebo to 4.8 mg once monthly achieved a 14.9% body-weight reduction by week 60.
