VIVUS LLC announced the results of a randomized trial (NCT04408586) evaluating the effect of QSYMIA®? (phentermine and topiramate extended-release capsules CIV) in combination with DELI compared to DELI plus placebo on weight loss and cardiovascular disease risk outcomes in adults with obesity. Results show that QSYMIA in combination with DELI significantly improved weight loss, percentage of body weight lost, and atherosclerotic cardiovascular disease (ASCVD) risk compared with DELI plus placebo.
The results are published in Obesity. A total of 80 participants were randomized (QSYMIA n=42, placebo n=38). The primary endpoint was total body weight loss at 3-months.
Key study results include: Among the 90% of participants who completed 3 months of study, significantly more weight was lost in the QSYMIA plus DELI group compared with the placebo plus DELI group (-10.82 kg vs. -4.04 kg, P=0.002). Among the 66% of participants who completed 12 months of study, significantly moreweight was lost in the QSY MIA plus DELI group compared With the placebo plus DELI group (15.32 kg vs.
-5.85 kg, P 5% (100% vs. 42%), >10% (83% vs. 11%), and >15% or more (43% vs.
5%) of baseline body weight at 12 months. Participants in the QSYMIAplus DELI group also had greater reductions compared with those in the placebo plus DELI group in waist circumference (-12.6 vs -2.07, P2 vs. -1.88 kg/m2), and diastolic blood pressure (-4.79 mm Hg vs.
-1.16 mm Hg, P=0.048).
