Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects

Orexigen

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Behavioral: CLI; Behavioral: Usual Care; Drug: NB

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764386

NB-404

Details and patient eligibility

About

The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

Enrollment: 242 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female or male, 18 to 60 years old
• Body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 for subjects with uncomplicated obesity, or BMI ≥27 kg/m2 and ≤45 kg/m2 for subjects with dyslipidemia and/or controlled hypertension

Exclusion criteria

• History of type 1 or type 2 diabetes mellitus diagnosis
• Myocardial infarction within 6 months prior to screening
• Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
• Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic strokes (i.e., transient ischemic attack is not exclusionary)
• History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that predispose subjects to seizures
• Past or planned surgical or device intervention (e.g., gastric banding) for obesity
• Chronic use or positive screen for opioids
• Regular use of tobacco products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

NB + CLI

Experimental group

Description:

Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)

Treatment:

Drug: NB

Behavioral: CLI

Usual Care

Other group

Description:

Usual Care (self-directed lifestyle intervention) Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.

Treatment:

Behavioral: Usual Care