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

Vivus

Status and phase: Completed; Phase 4

Conditions: Blood Pressure

Treatments: Drug: VI-0521; Drug: Phentermine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05215418

OB-409

Details and patient eligibility

About

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).

Enrollment: 565 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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565 participants in 3 patient groups, including a placebo group

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

Experimental group

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

Treatment:

Drug: VI-0521

Phentermine 30mg

Active Comparator group

Description:

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

Treatment:

Drug: Phentermine

Placebo

Placebo Comparator group

Description:

Weeks 1-8: Placebo oral capsule, once daily

Treatment:

Drug: Placebo