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 - Full Text View

Purpose

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. 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).

Condition	Intervention	Phase
Obesity Overweight	Drug: NB Behavioral: CLI Behavioral: Usual Care	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Open-Label, Controlled, 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 (The Ignite Study)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity

Drug Information available for: Naltrexone Naltrexone hydrochloride Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:

To assess effect of intended clinical method of use 32 mg naltrexone SR/360 mg bupropion SR in conjunction with a comprehensive lifestyle intervention (CLI) compared to Usual Care (minimal lifestyle intervention program) on percent change in body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 5% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on the absolute change in body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including waist circumference [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in systolic blood pressure [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting glucose [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including eating behavior [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 10% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 15% of baseline body weight [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting triglycerides [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting LDL cholesterol [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: Yes ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting HDL cholesterol [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in diastolic blood pressure [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in heart rate [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting insulin [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including homeostasis model assessment - insulin resistance (HOMA-IR) [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including sexual function [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including weight related quality of life [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

Other Outcome Measures:

To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 5% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 10% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on the percentage of subjects achieving a loss of at least 15% of baseline body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess effect of intended clinical method of use 32 mg naltrexone SR/360 mg bupropion SR in conjunction with a comprehensive lifestyle intervention (CLI) compared to Usual Care (minimal lifestyle intervention program) on percent change in body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on the absolute change in body weight [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including waist circumference [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting triglycerides [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting LDL cholesterol [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in cardiovascular risk factors including fasting HDL cholesterol [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in systolic blood pressure [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in diastolic blood pressure [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in heart rate [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting glucose [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including fasting insulin [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in measures of glucose metabolism including homeostasis model assessment - insulin resistance (HOMA-IR) [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including eating behavior [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including sexual function [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]
To assess the effect of NB and CLI compared to Usual Care on changes in patient reported outcomes including weight-related quality of life [ Time Frame: Baseline to Week 52, Baseline to Week 78 ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	February 2013
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NB + CLI Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)	Drug: NB Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) Behavioral: CLI 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)	Behavioral: Usual Care Usual Care is a self-directed lifestyle intervention program

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764386

Locations

United States, Colorado
Radiant Research
Denver, Colorado, United States, 80239
United States, Missouri
Radiant Research, Inc.
Saint Louis, Missouri, United States, 63151
United States, North Carolina
PMG Research of Raleigh
Cary, North Carolina, United States, 27518
PMG Research of Winston-Salem
Hickory, North Carolina, United States, 28601
PMG Research of Raleigh
Raleigh, North Carolina, United States, 27609
PMG Research of Salisbury
Salisbury, North Carolina, United States, 28144
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, Ohio
Radiant Research-Akron
Akron, Ohio, United States, 44311
Radiant Research, Inc.
Columbus, Ohio, United States, 43212
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States, 29621
Radiant Research, Greer
Greer, South Carolina, United States, 29651
PMG Research of Charleston
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
PMG Research of Bristol
Bristol, Tennessee, United States, 37620
United States, Texas
Radiant Research Dallas-North
Dallas, Texas, United States, 75231
United States, Utah
Radiant Research, SLC
Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators

Orexigen Therapeutics, Inc

Investigators

Study Director:

Senior Vice President, Head of Global Development

Orexigen Therapeutics, Inc

More Information

No publications provided

Responsible Party:	Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT01764386 History of Changes
Other Study ID Numbers:	NB-404
Study First Received:	January 4, 2013
Last Updated:	February 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:

obesity, overweight

Additional relevant MeSH terms:

Body Weight
Obesity
Overweight
Signs and Symptoms
Overnutrition
Nutrition Disorders
Naltrexone
Bupropion
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013