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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

565 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2023-04-17

Brief Summary

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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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Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

VI-0521

Intervention Type DRUG

Phentermine/Topiramate Top Dose 15 mg/92 mg capsule

Phentermine 30mg

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

Group Type ACTIVE_COMPARATOR

Phentermine

Intervention Type DRUG

Phentermine 30 mg capsule

Placebo

Weeks 1-8: Placebo oral capsule, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive oral capsule

Interventions

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VI-0521

Phentermine/Topiramate Top Dose 15 mg/92 mg capsule

Intervention Type DRUG

Phentermine

Phentermine 30 mg capsule

Intervention Type DRUG

Placebo

Inactive oral capsule

Intervention Type DRUG

Other Intervention Names

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Qsymia Phentermine and topiramate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No