Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
VIVUS LLC
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
