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

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VIVUS LLC
• Treatments: Phentermine; Topiramate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.