A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects

Phase 4 Completed 565 enrolled VIVUS LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).

Timeline

Start: 2022-01-25
Primary completion: 2023-04-11
Completion: 2023-04-17

Outcome

Met primary endpoint

paper Between-group difference for PHEN/TPM versus placebo was -3.2 mmHg (95 % CI: -5.48, -0.93 mmHg; p = 0.0059). PMID 38304225 ↗

paper The between-group difference for PHEN/TPM versus phentermine 30 mg was -4.7 mmHg (95 % CI: -6.96, -2.45 mmHg; p < 0.0001). PMID 38304225 ↗

Publications

Bays HE, Hsia DS, Nguyen LT, Peterson CA, Varghese ST. Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study. Obes Pillars. 2024 Jan 8;9:100099. doi: 10.1016/j.obpill.2024.100099. eCollection 2024 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Phentermine	Small molecule	30 mg	Oral
Subject	VI-0521	Unknown	—	Oral