A study to test whether VI-0521 or placebo (contains no active drug substance) reduce the chances of developing health problems related to the functioning of the heart and vascular system (blood vessels), such as heart attacks or strokes.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16000

Inclusion Criteria

1. Age =45 years;
2. BMI =27 kg/m2 (=24 kg/m2 for Asians);
3. Waist circumference =102 cm (40 in) for men or =88 cm (35 in) for women (=90 cm [35 in] and =80 cm [31 in] for Asian men and women, respectively);
4. Stable body weight during the previous 2 months (±3% self reported);
5. Be classified into one of the following three risk categories: Stratum A (High stroke risk), Stratum B (High CVD risk) or Stratum C (Intermediate CVD risk) - Please see protocol for details.
6. Women of childbearing potential must be using adequate contraception, defined as a double-barrier method, stable hormonal contraception plus single barrier, or previously documented tubal ligation. Women are considered to be of childbearing potential unless they are =50 years of age with spontaneous amenorrhea for at least 12 months or have had a hysterectomy and/or bilateral oophorectomy;
7. Ability to understand the study procedures and provide written informed consent; and
8. Willingness and ability to comply with scheduled study visits and study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6000

Exclusion Criteria

To be eligible for enrollment into this study, subjects must not meet any of the following criteria:
1. Concurrent use of glucagon-like peptide-1 (GLP-1) analogs and all forms of insulin;
2. Uncontrolled hypertension (SBP >180 mmHg or DBP >100 mmHg) at the time of randomization. Subjects with uncontrolled hypertension may be re-screened once blood pressure has been controlled and the antihypertensive regimen has been stabilized for at least 2 months prior to randomization;
3. Congestive Heart Failure (CHF) accompanied by hypotension; New York Heart Association (NYHA) CHF Class III or greater;
4. Condition or disease interfering with metabolism, such as untreated hypothyroidism, Cushing’s syndrome, or type 1 diabetes;
5. History or presence of significant eating disorder, such as binge eating, bulimia, or anorexia nervosa;
6. Pheochromocytoma or carcinoid syndrome;
7. Renal dialysis required or severe renal impairment, defined as creatinine clearance <30 mL/min;
8. History or presence of potentially life-threatening cardiac arrhythmia;
9. History of nephrolithiasis;
10. Severe hepatic impairment (i.e., Child-Pugh class C);
11. Prior or planned surgery for weight loss, including cosmetic liposuction;
12. Unwillingness or inability to participate in the diet or physical activity program;
13. Clinically significant thyroid dysfunction as evidenced by signs or symptoms of hypothyroidism or use of thyroid hormone treatment that has not been stable for at least 3 months prior to randomization;
14. Use of chronic systemic glucocorticoid therapy or any other steroid hormone therapy that has not been stable for at least 3 months prior to randomization;
15. Prior suicide attempt or any current active suicidal ideation (i.e., suicidal ideation with some intent to act, without specific plan or active suicidal ideation with specific plan and intent);
16. History of major depressive disorder within the last 2 years;
17. History of bipolar disorder, obsessive compulsive disorder, borderline personality disorder, psychotic depression, schizophrenia, schizoaffective disorder, or any other psychotic disorder;
18. Current abuse of or dependence on any drug (other than nicotine), including alcohol;
19. History of or current treatment for seizures;
20. History of any malignancy within the past 5 years other than basal or squamous cell carcinomas of the skin or cervical carcinomas following curative surgical resection;
21. Planned revascularization or angiography during the study;
22. History of angle-closure glaucoma or any past or present use of medications to treat increased intraocular pressure;
23. Women who are pregnant, breastfeeding, or intend to become pregnant during the study;
24. Any of the following abnormal laboratory values (tests may be repeated per discretion of the investigator):
a. Bicarbonate <20 mEq/L;
b. Potassium <3.5 mEq/L;
c. Triglycerides >500 mg/dL;
d. HbA1c >10.0%; or
e. Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN);
25. History of a positive screening test for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus;
26. Treatment with phentermine, topiramate, lorcaserin, or any other over-the-counter (OTC) or prescription weight loss drug within 3 months of screening;
27. Known allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
28. Use of any investigational medication or device for a

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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