Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.


Options:
A: Inclusion Criteria:

* Written and signed informed consent
* Age greater than or equal to 55 years
* Abdominal obesity defined by waist circumference \> 88 cm (35 inches) in women and \> 102 cm (40 inches) in men
* Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors:

  1. Triglyceride level equal to or greater than 150 mg/dL
  2. HDL cholesterol less than 40 mg/dL in men or 50 mg/dL in women
  3. Fasting glucose of equal to or greater than 110 mg/dL
  4. High blood pressure defined as equal to or greater than 140 mmHg systolic and/or equal to or greater than 90 mmHg diastolic at screening visit or current treatment by antihypertensive medication.
* Ultrasonographic evidence at Screening quantitative B-mode ultrasound imaging of a minimal CIMT measurement of greater than or equal to 0.7 mm in either of the far walls of the common carotid artery, and maximal CIMT measurement less than 3 mm in any carotid artery segment.
* All 6 carotid artery segments must have ultrasound images for all CIMT measurements
* Screening CIMT recording deemed to be of acceptable CIMT image quality, and demonstrating adherence to the CIMT interrogation protocol, as determined by the Imaging Core Laboratory's assessment.

Exclusion Criteria:

* History of very low calorie diet or surgical procedures for weight loss within 6 months prior to screening visit
* Obesity of known endocrine origin
* Uncontrolled diabetes, i.e. with HbA1c \> 10%
* Anticipated survival less than 27 months
* Presence of any severe medical or psychological condition, that in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
* Presence of any other condition (e.g. geographic, social, or other), actual or anticipated, that the Investigator feels would restrict or limit the subject's participation for the duration of the study
* Receipt of any investigational treatment (drug or device) within 30 days prior to Screening
* Previous participation in a rimonabant study
* Total occlusion of any carotid artery segment
* Previous history of carotid intervention
* Patient considered at high risk of carotid intervention during the next 27 months
B: Inclusion Criteria:

* Informed Consent
* BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
* 70 years of age or less
* Have 2 or more of the following obesity-related co-morbid conditions:

  * Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
  * Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
  * Requirement for 2 or more medications to achieve control (\<140/90 mmHg)
* Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (\<200 mg/dL)
* At lease one of the following metabolic criteria:

  * Fasting blood glucose level \> 100 mg/dL
  * Glucose level \> 140 mg/dL
  * Diagnosis of type 2 diabetes
* Waist circumference ≥ 102 cm for men or ≥88 cm for women

Exclusion Criteria:

* Stroke/MI/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* Glaucoma or intraocular pressure
* Pregnancy or breastfeeding
* Drug or Alcohol abuse
* Smoking cessation within previous 3 months or plans to quit smoking during study
* Eating disorders
* Cholelithiasis within past 6 months
* Excluded medications
* Type 1 diabetes or use of any antidiabetic medication other than metformin
* Previous bariatric surgery
* Bipolar disorder or psychosis
* Steroid hormone therapy
* Systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg
* Creatinine clearance \< 60 mL/minute
C: Inclusion Criteria:

* Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.
* Ability to complete a 1 year study

Exclusion Criteria:

* Pregnancy
* Diabetes mellitus (type I, II or other)
* History of symptomatic heart valve disease
* Serious or unstable current or past medical conditions
D: Inclusion Criteria:

* Informed consent
* Body mass index equal to or above 30 kg/m\^2
* Stable body weight (less than 5% self-reported change during the previous 3 months)
* Diagnosis of moderate or severe obstructive sleep apnoea (OSA)
* Unwilling or unable to use continuous positive airway pressure (CPAP) (or other positive airway pressure) treatment. No CPAP (or other positive airway pressure) treatment for at least four weeks prior to screening
* Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule and dietary advice and complete trial related questionnaires

Exclusion Criteria:

* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening
* Diagnosis of type 1 or type 2 diabetes per judgement of the investigator
* Glycosylated haemoglobin (HbA1c) equal to or above 6.5%
* Significant craniofacial abnormalities that may cause OSA
* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
* Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone within the previous 3 months prior to screening
* Obesity induced by drug treatment
* Treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine within the last 3 month prior to screening
* Previous surgical treatment for obesity
* Screening calcitonin equal to or above 50 ng/L
* Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
* Personal history of non-familial Medullary Thyroid Carcinoma
* History of chronic pancreatitis or idiopathic acute pancreatitis
* History of Major Depressive Disorder or suicide attempts
* Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg

Answer: B