Phase 4
N=565
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
Blood Pressure
Bottom Line
View on ClinicalTrials.gov: NCT05215418 ↗Enrolled (actual)
565
Serious AEs
0.2%
Results posted
Jun 2024
Primary outcome: Primary: Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM — -3.3; 1.4; -0.1 mmHg — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- VI-0521 (Drug); Phentermine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VIVUS LLC
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM |
-3.3; 1.4; -0.1 | < 0.001 sig |
| SECONDARY Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM |
0.8; 2.4; -0.4 | 0.0277 sig |
| SECONDARY Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic |
-4.3; -1.2; -1.7; -1.3; 1.0; -1.1 | 0.0109 sig |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05215418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.