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

Phase 4

Completed

• Conditions: Blood Pressure
• Interventions: Drug: Placebo; Drug: Phentermine; Drug: VI-0521

• Registration Number: NCT05215418
• Lead Sponsor: VIVUS LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study Start: 2022-01-25
• Study First Posted: 2022-01-31
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-17
• Disposition First Submitted: 2024-04-09
• Results First Submitted: 2024-04-30
• Results First Submitted QC: 2024-05-23
• Status Verified: 2024-06
• Results First Posted: 2024-06-18
• Disposition First Posted: 2024-06-18
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Weeks 1-8: Placebo oral capsule, once daily
Phentermine 30mg	Phentermine	Weeks 1-8: Phentermine 30mg oral capsule, once daily
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)	VI-0521	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Clinical Site; 🇺🇸 Norfolk, Virginia, United States

Clinical site; 🇺🇸 Salt Lake City, Utah, United States