Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.

Key facts

Study ID

NCT01601704

Run by

Orexigen Therapeutics, Inc

People needed

8910

Starts

2012-06-01

Expected to finish

2015-08-01

Last updated by the study team

2017-02-27

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥50 years of age (women) or ≥45 years of age (men)
• Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2
• Waist circumference ≥88 cm (women) or ≥102 cm (men)
• At increased risk of adverse cardiovascular outcomes:
• Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:
• History of documented myocardial infarction >3 months prior to screening
• History of coronary revascularization
• History of carotid or peripheral revascularization
• Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
• Ankle brachial index <0.9 (by simple palpation) within prior 2 years
• ≥50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years
• AND/OR
• Type 2 diabetes mellitus with at least 2 of the following:
• Hypertension (controlled with or without pharmacotherapy at <145/95 mm Hg)
• Dyslipidemia requiring pharmacotherapy
• Documented low HDL cholesterol (<50 mg/dL in women or <40 mg/dL in men) within prior 12 months
• Current tobacco smoker

You may not qualify if…

• Myocardial infarction within 3 months prior to screening
• Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
• Clinical history of cerebrovascular disease (stroke)
• History of tachyarrhythmia other than sinus tachycardia
• Planned bariatric surgery, cardiac surgery, or coronary angioplasty
• History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures
• History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary)
• Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Scottsboro, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tuscson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Carmichael, California, United States
• Study site — Escondido, California, United States
• Study site — Fresno, California, United States
• Study site — Harbor City, California, United States
• Study site — Huntington Beach, California, United States
• Study site — La Jolla, California, United States
• Study site — Lomita, California, United States
• Study site — Los Angeles, California, United States
• Study site — Paramount, California, United States
• Study site — Pasadena, California, United States
• Study site — Riverside, California, United States
• Study site — Sacramento, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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