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

June 21, 2024 updated by: VIVUS LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

565

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Clinical Site
      • Mobile, Alabama, United States, 36608
        • Clinical Site
    • California
      • Lincoln, California, United States, 95648
        • Clinical Site
      • Long Beach, California, United States, 90806
        • Clinical Site
      • Sacramento, California, United States, 95821
        • Clinical Site
      • Spring Valley, California, United States, 91978
        • Clinical Site
      • Upland, California, United States, 91786
        • Clinical Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Clinical Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Site
      • Miami, Florida, United States, 33155
        • Clinical Site
      • Port Orange, Florida, United States, 23227
        • Clinical Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Clinical Site
      • Evansville, Indiana, United States, 47714
        • Clinical Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Clinical Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Clinical Site
      • Louisville, Kentucky, United States, 40213
        • Clinical Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Clinical Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Clinical Site
    • Montana
      • Butte, Montana, United States, 59701
        • Clinical Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Clinical Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Clinical Site
    • South Carolina
      • Columbia, South Carolina, United States, 29223
        • Clinical Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Clinical Site
    • Texas
      • Friendswood, Texas, United States, 77546
        • Clinical Site
      • North Richland Hills, Texas, United States, 76180
        • Clinical Site
      • San Antonio, Texas, United States, 78215
        • Clinical Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Clinical Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
Drug: VI-0521
Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
Other Names:
  • Qsymia
  • Phentermine and topiramate
Active Comparator: Phentermine 30mg
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Drug: Phentermine
Phentermine 30 mg capsule
Placebo Comparator: Placebo
Weeks 1-8: Placebo oral capsule, once daily
Drug: Placebo
Inactive oral capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 8
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.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2022

Primary Completion (Actual)

April 11, 2023

Study Completion (Actual)

April 17, 2023

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB-409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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