Blood PressurePhase 4NCT05215418

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

A Phase 4 study testing VI-0521 and Phentermine in people with Blood Pressure, run by VIVUS LLC at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Blood Pressure
What is being tested?: VI-0521 and Phentermine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 565 participants
Where: 28 sitesUnited States
Study dates: 25 Jan 2022to 17 Apr 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 10Show fewer

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.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

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

Other trials in United States

About this study

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

Conditions: Blood Pressure
Being tested: VI-0521, Phentermine, Placebo
Keywords: Obesity, Overweight, Qsymia, ABPM
Medical subject headings: Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VI-0521Drug
Also called Qsymia, Phentermine and topiramate
Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
PhentermineDrug
Phentermine 30 mg capsule
PlaceboDrug
Inactive oral capsule

Study groups in NCT05215418
Study group	Role	What they receive
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)	Experimental	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 Receives: Drug: VI-0521
Phentermine 30mg	Active comparator	Weeks 1-8: Phentermine 30mg oral capsule, once daily Receives: Drug: Phentermine
Placebo	Placebo comparator	Weeks 1-8: Placebo oral capsule, once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Week 8

Secondary outcomes (2)

Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM
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.
Measured: Baseline to Week 8
Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic
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.
Measured: Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 202217 Apr 2023

First posted31 Jan 2022
Study start25 Jan 2022
Primary completion11 Apr 2023
Study completion17 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 565 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05215418
Sponsor's protocol ID: OB-409
Status last verified: Jun 2024
First submitted: 17 Jan 2022
Last updated: 17 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 38304225

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05215418
Acronym / sponsor ID: OB-409
Conditions: Blood Pressure
Keywords: Obesity, Overweight, Qsymia, ABPM
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 565 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: 25 Jan 2022 (actual)
Primary completion: 11 Apr 2023 (actual)
Study completion: 17 Apr 2023 (actual)
First posted: 31 Jan 2022 (actual)
Results: Posted 18 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)	Experimental	Drug: VI-0521Week 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 comparator	Drug: PhentermineWeeks 1-8: Phentermine 30mg oral capsule, once daily
Placebo	Placebo comparator	Drug: PlaceboWeeks 1-8: Placebo oral capsule, once daily

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VI-0521Also: Qsymia, Phentermine and topiramatePhentermine/Topiramate Top Dose 15 mg/92 mg capsule	Drug	VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
PhenterminePhentermine 30 mg capsule	Drug	Phentermine 30mg
PlaceboInactive oral capsule	Drug	Placebo

Primary outcome

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.

2 secondary outcomes

Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM
Time frame: 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

Results and safety

Results posted to the registry on 18 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)	190	156
Phentermine 30mg	191	167
Placebo	184	164

Primary outcome: Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM

Time frame: Baseline to Week 8. Least squares mean (Standard Error). Unit: mmHg

Measure	VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) n = 122	Phentermine 30mg n = 133	Placebo n = 130
Value	-3.3 (1.07)	1.4 (1.05)	-0.1 (1.04)

VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) vs Phentermine 30mg: p < 0.001, ANCOVA
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) vs Placebo: p = 0.0059, ANCOVA
Phentermine 30mg vs Placebo: p = 0.1867, ANCOVA

Population analysed: Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as: 1. Randomized and received at least one dose of study drug; 2. ≥ 80% treatment compliance; 3. Last daily dose of study drug administered on the same date that ABPM was initiated at Week 8/End of Study or early termination (EOS); 4. ≥ 23.5 hours of ABPM data at baseline and at Week 8/EOS or early termination, and ≥ 75% ABPM readings; 5. No major protocol deviation that impacted ABPM readings.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)	0 of 190 (0%)	66 of 190 (34.7%)	0 of 190
Phentermine 30mg	1 of 191 (0.5%)	44 of 191 (23%)	0 of 191
Placebo	0 of 184 (0%)	6 of 184 (3.3%)	0 of 184

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38304225Bays 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing VI-0521 and Phentermine in people with Blood Pressure, run by VIVUS LLC at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215418, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.