Clinical trial NCT05215418: A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure
Keywords: Obesity
Overweight
Qsymia
ABPM
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM
timeFrame: Baseline to Week 8
measure: Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Clinical Site
state: Alabama
city: Mobile
country: United States
facility: Clinical Site
state: Alabama
city: Lincoln
country: United States
facility: Clinical Site
state: California
city: Long Beach
country: United States
facility: Clinical Site
state: California
city: Sacramento
country: United States
facility: Clinical Site
state: California
city: Spring Valley
country: United States
facility: Clinical Site
state: California
city: Upland
country: United States
facility: Clinical Site
state: California
city: Washington
country: United States
facility: Clinical Site
state: District of Columbia
city: Coral Gables
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Port Orange
country: United States
facility: Clinical Site
state: Florida
city: Brownsburg
country: United States
facility: Clinical Site
state: Indiana
city: Evansville
country: United States
facility: Clinical Site
state: Indiana
city: Wichita
country: United States
facility: Clinical Site
state: Kansas
city: Lexington
country: United States
facility: Clinical Site
state: Kentucky
city: Louisville
country: United States
facility: Clinical Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Clinical Site
state: Louisiana
city: Kansas City
country: United States
facility: Clinical Site
state: Missouri
city: Butte
country: United States
facility: Clinical Site
state: Montana
city: Cary
country: United States
facility: Clinical Site
state: North Carolina
city: Eugene
country: United States
facility: Clinical Site
state: Oregon
city: Columbia
country: United States
facility: Clinical Site
state: South Carolina
city: Knoxville
country: United States
facility: Clinical Site
state: Tennessee
city: Friendswood
country: United States
facility: Clinical Site
state: Texas
city: North Richland Hills
country: United States
facility: Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Site
state: Texas
city: Salt Lake City
country: United States
facility: Clinical site
state: Utah
city: Norfolk
country: United States
facility: Clinical Site
state: Virginia
Study officials:
References: