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

Primary Purpose

Blood Pressure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VI-0521
Phentermine
Placebo
Sponsored by
VIVUS LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure focused on measuring Obesity, Overweight, Qsymia, ABPM

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)

Phentermine 30mg

Placebo

Arm Description

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

Weeks 1-8: Phentermine 30mg oral capsule, once daily

Weeks 1-8: Placebo oral capsule, once daily

Outcomes

Primary Outcome Measures

Change from baseline to Week 8 in mean systolic blood pressure as measured by 24-hr ABPM

Secondary Outcome Measures

Change from baseline to Week 8 in mean diastolic blood pressure as measured by 24-hr ABPM
Mean change in systolic and diastolic blood pressure from baseline to Week 8 as measured in clinic

Full Information

First Posted
January 17, 2022
Last Updated
September 11, 2023
Sponsor
VIVUS LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05215418
Brief Title
A Study of VI-0521 on Ambulatory Blood Pressure in Overweight or Obese Subjects
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVUS LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure
Keywords
Obesity, Overweight, Qsymia, ABPM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
567 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Arm Type
Experimental
Arm Description
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
Arm Title
Phentermine 30mg
Arm Type
Active Comparator
Arm Description
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Weeks 1-8: Placebo oral capsule, once daily
Intervention Type
Drug
Intervention Name(s)
VI-0521
Other Intervention Name(s)
Qsymia, Phentermine and topiramate
Intervention Description
Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
Intervention Type
Drug
Intervention Name(s)
Phentermine
Intervention Description
Phentermine 30 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive oral capsule
Primary Outcome Measure Information:
Title
Change from baseline to Week 8 in mean systolic blood pressure as measured by 24-hr ABPM
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change from baseline to Week 8 in mean diastolic blood pressure as measured by 24-hr ABPM
Time Frame
Baseline to Week 8
Title
Mean change in systolic and diastolic blood pressure from baseline to Week 8 as measured in clinic
Time Frame
Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clinical Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Clinical Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Site
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Clinical Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Clinical Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Clinical Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Clinical Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Clinical Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Clinical Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Clinical Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
23227
Country
United States
Facility Name
Clinical Site
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Clinical Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Clinical Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Clinical Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Clinical Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Clinical Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Clinical Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Clinical Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Clinical Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Clinical Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Clinical Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29223
Country
United States
Facility Name
Clinical Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Site
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Clinical Site
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Clinical Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

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

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