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

NCT ID: NCT01764386

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-09-30

Brief Summary

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).

Conditions

Obesity; Overweight

Keywords

obesity, overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NB + CLI

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

Group Type: EXPERIMENTAL

NB

Intervention Type: DRUG

Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)

CLI

Intervention Type: BEHAVIORAL

The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.

Usual Care

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.

Group Type: OTHER

Usual Care

Intervention Type: BEHAVIORAL

Usual Care is a self-directed lifestyle intervention program

Interventions

NB

Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)

Intervention Type: DRUG

CLI

The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.

Intervention Type: BEHAVIORAL

Usual Care

Usual Care is a self-directed lifestyle intervention program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orexigen Therapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Vice President, Head of Global Development

Role: STUDY_DIRECTOR

Orexigen Therapeutics, Inc

Locations

Radiant Research

Denver, Colorado, United States

Radiant Research, Inc.

St Louis, Missouri, United States

PMG Research of Raleigh

Cary, North Carolina, United States

PMG Research of Winston-Salem

Hickory, North Carolina, United States

PMG Research of Raleigh

Raleigh, North Carolina, United States

PMG Research of Salisbury

Salisbury, North Carolina, United States

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Radiant Research-Akron

Akron, Ohio, United States

Radiant Research, Inc.

Columbus, Ohio, United States

Radiant Research

Anderson, South Carolina, United States

Radiant Research, Greer

Greer, South Carolina, United States

PMG Research of Charleston

Mt. Pleasant, South Carolina, United States

PMG Research of Bristol

Bristol, Tennessee, United States

Radiant Research Dallas-North

Dallas, Texas, United States

Radiant Research, SLC

Salt Lake City, Utah, United States

Countries

United States

References

Halseth A, Shan K, Walsh B, Gilder K, Fujioka K. Method-of-use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity. Obesity (Silver Spring). 2017 Feb;25(2):338-345. doi: 10.1002/oby.21726. Epub 2016 Dec 27.

Reference Type: DERIVED

PMID: 28026920 (View on PubMed)

Other Identifiers

NB-404

Identifier Type: -

Identifier Source: org_study_id