A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
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
1 other identifier
interventional
565
1 country
28
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2022
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2022
CompletedStudy Start
First participant enrolled
January 25, 2022
CompletedFirst Posted
Study publicly available on registry
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2023
CompletedResults Posted
Study results publicly available
June 18, 2024
CompletedJuly 17, 2024
June 1, 2024
1.2 years
January 17, 2022
April 30, 2024
June 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM
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 Outcomes (2)
Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM
Baseline to Week 8
Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic
Baseline to Week 8
Study Arms (3)
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
EXPERIMENTALWeek 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
Phentermine 30mg
ACTIVE COMPARATORWeeks 1-8: Phentermine 30mg oral capsule, once daily
Placebo
PLACEBO COMPARATORWeeks 1-8: Placebo oral capsule, once daily
Interventions
Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
Eligibility Criteria
You may qualify 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 qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
Study Sites (28)
Clinical Site
Anniston, Alabama, 36207, United States
Clinical Site
Mobile, Alabama, 36608, United States
Clinical Site
Lincoln, California, 95648, United States
Clinical Site
Long Beach, California, 90806, United States
Clinical Site
Sacramento, California, 95821, United States
Clinical Site
Spring Valley, California, 91978, United States
Clinical Site
Upland, California, 91786, United States
Clinical Site
Washington D.C., District of Columbia, 20011, United States
Clinical Site
Coral Gables, Florida, 33134, United States
Clinical Site
Miami, Florida, 33155, United States
Clinical Site
Port Orange, Florida, 23227, United States
Clinical Site
Brownsburg, Indiana, 46112, United States
Clinical Site
Evansville, Indiana, 47714, United States
Clinical Site
Wichita, Kansas, 67207, United States
Clinical Site
Lexington, Kentucky, 40509, United States
Clinical Site
Louisville, Kentucky, 40213, United States
Clinical Site
Baton Rouge, Louisiana, 70808, United States
Clinical Site
Kansas City, Missouri, 64114, United States
Clinical Site
Butte, Montana, 59701, United States
Clinical Site
Cary, North Carolina, 27518, United States
Clinical Site
Eugene, Oregon, 97404, United States
Clinical Site
Columbia, South Carolina, 29223, United States
Clinical Site
Knoxville, Tennessee, 37920, United States
Clinical Site
Friendswood, Texas, 77546, United States
Clinical Site
North Richland Hills, Texas, 76180, United States
Clinical Site
San Antonio, Texas, 78215, United States
Clinical site
Salt Lake City, Utah, 84124, United States
Clinical Site
Norfolk, Virginia, 23502, United States
Related Publications (1)
Bays HE, Hsia DS, Nguyen LT, Peterson CA, Varghese ST. Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study. Obes Pillars. 2024 Jan 8;9:100099. doi: 10.1016/j.obpill.2024.100099. eCollection 2024 Mar.
PMID: 38304225DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Participants with baseline blood pressure greater than 140/90 were excluded. Of the 565 total participants randomized and treated with study drug, 180 participants were excluded from the per protocol population used for the primary analysis due to participants' reluctance or inability to properly complete end of study ABPM assessments.
Results Point of Contact
- Title
- Lan Nguyen
- Organization
- Vivus LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2022
First Posted
January 31, 2022
Study Start
January 25, 2022
Primary Completion
April 11, 2023
Study Completion
April 17, 2023
Last Updated
July 17, 2024
Results First Posted
June 18, 2024
Record last verified: 2024-06