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Completed

NCT Number: NCT05215418

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

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).

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Key information

Conditions

Blood Pressure Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Site, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VI-0521

Drug

Phentermine/Topiramate Top Dose 15 mg/92 mg capsule

Other names: Qsymia, Phentermine and topiramate

Phentermine

Drug

Phentermine 30 mg capsule

Placebo

Drug

Inactive oral capsule

Primary outcomes

  1. Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM

    Time frame: Baseline to Week 8

    The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.

Secondary outcomes

  1. Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM

    Time frame: Baseline to Week 8

    The change between diastolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.

  2. Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic

    Time frame: Baseline to Week 8

    The change between systolic and diastolic blood pressure measured in the clinic at Week 8 relative to the baseline measurements after subjects are seated comfortably for at least 10 minutes prior to taking blood pressure. In clinic blood pressure for determining hypertension was the average of three successive blood pressure readings, collected at least 2 minutes apart. The mean of the three values was be recorded as the subject's blood pressure.

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind Study to Compare the Effects of VI-0521,Phentermine, and Placebo on Ambulatory Blood Pressure in Overweight or Obese Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2022
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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