Table 1.

Characteristics of source study: LIGHT cardiovascular outcomes trial [9].

Variable	Description
Description	Phase 3b, placebo-controlled, randomized cardiovascular outcomes trial (CVOT)
Duration	2–4 years
N (ITT)	8910
Population	Individuals at increased risk of adverse CV outcomes - Pre-existing CVD OR - T2DM + ≥2 of: hypertension, dyslipidemiaa, current smoking
Age range	Men ≥45 years Women ≥50 years
BMI inclusion criteria	27–50 kg/m2
Other key inclusion criteria	Men: WC ≥ 102 cm Women: WC ≥ 88 cm
Randomization	1:1, NB:PL
NB dosing	Initial dose: One tablet 8/90 mg Maintenance dose: 2 tablets b.i.d. (32/360 mg)
Timing of study visits	BL, 8, 16, 26, 52, 78, 104, 130, 156, 182, and 208
Antihyperglycemic medication	Allowed, with no stated specific requirements
Other CV medications (e.g., for hypertension, dyslipidemia)	Allowed, with no stated specific requirements
Other weight loss intervention	Encouraged (but not required) to participate in an Internet-based weight management program All had access to a personal weight-loss coach, programs to track weight, meals, and physical activity; and a low-fat, low-calorie meal plan
Anthropometric data recorded	Weight (kg), height (cm), waist circumference (cm)
Primary endpoint	Time from randomization to first confirmed occurrence of a major adverse CV event (CV death, nonfatal MI, or nonfatal stroke)

BL baseline, BMI body mass index, BP blood pressure, CV cardiovascular, CVD cardiovascular disease, FBG fasting blood glucose, HbA1c glycated hemoglobin, MI myocardial infarction, NB extended-release naltrexone/extended-release bupropion 32/360 mg, PL placebo.

^aDyslipidemia requiring pharmacotherapy and/or high-density lipoprotein cholesterol <1.30 mmol/L (men) or <1.04 mmol/L.