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

Study Overview
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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).

Official Title
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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
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Blood Pressure

Intervention / Treatment
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* Drug: VI-0521
* Drug: Phentermine
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)<br>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<br>* Phentermine/Topiramate Top Dose 15 mg/92 mg capsule<br>* Other names: Phentermine and topiramate;|
| Active Comparator: Phentermine 30mg<br>Weeks 1-8: Phentermine 30mg oral capsule, once daily | Drug: Phentermine<br>* Phentermine 30 mg capsule<br>|
| Placebo Comparator: Placebo<br>Weeks 1-8: Placebo oral capsule, once daily | Drug: Placebo<br>* Inactive oral capsule<br>|

What is the study measuring?
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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 |  | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Qsymia, ABPM