A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
Completed · Phase 4 · Has a placebo group
Conditions studied: Blood Pressure
In brief
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).
Key facts
- Study ID
- NCT05215418
- Run by
- VIVUS LLC
- People needed
- 565
- Starts
- 2022-01-25
- Expected to finish
- 2023-04-17
- Last updated by the study team
- 2024-07-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Overweight/obese adult males/females 18-75 years of age with a BMI ≥ 27 kg/m2;
- At least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, Type 2 diabetes mellitus [T2DM] or prediabetes, or obstructive sleep apnea).
- Must be ambulatory, willing, and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.
You may not qualify if…
- Screening blood pressure of > 140/90 mmHg;
- Type 1 diabetes; T2DM treated with SFUs, GLP-1 receptor agonists, SGLT inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization;
- Clinically significant cardiac, hepatic, renal, pulmonary, or thyroid disease;
- History of bipolar disorder, psychosis, greater than one lifetime episode of major depressive disorder, or presence or history of suicidal behavior or suicidal ideation with intent to act;
- History of glaucoma;
- Night shift workers;
- Obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program within 3 months prior to screening; and
- Smoking cessation within 3 months prior to screening;
- Use of antihypertensive medications, antidiabetic medications, statins or other lipid lowering agents, or CPAP therapy that has not been stable for at least 3 months prior to randomization;
- COVID-19 vaccination or treatment for severe COVID-19 infection within a month prior to randomization.
Where it is running
- Clinical Site — Anniston, Alabama, United States
- Clinical Site — Mobile, Alabama, United States
- Clinical Site — Lincoln, California, United States
- Clinical Site — Long Beach, California, United States
- Clinical Site — Sacramento, California, United States
- Clinical Site — Spring Valley, California, United States
- Clinical Site — Upland, California, United States
- Clinical Site — Washington D.C., District of Columbia, United States
- Clinical Site — Coral Gables, Florida, United States
- Clinical Site — Miami, Florida, United States
- Clinical Site — Port Orange, Florida, United States
- Clinical Site — Brownsburg, Indiana, United States
- Clinical Site — Evansville, Indiana, United States
- Clinical Site — Wichita, Kansas, United States
- Clinical Site — Lexington, Kentucky, United States
- Clinical Site — Louisville, Kentucky, United States
- Clinical Site — Baton Rouge, Louisiana, United States
- Clinical Site — Kansas City, Missouri, United States
- Clinical Site — Butte, Montana, United States
- Clinical Site — Cary, North Carolina, United States
- Clinical Site — Eugene, Oregon, United States
- Clinical Site — Columbia, South Carolina, United States
- Clinical Site — Knoxville, Tennessee, United States
- Clinical Site — Friendswood, Texas, United States
- Clinical Site — North Richland Hills, Texas, United States
Full record on ClinicalTrials.gov
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