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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01764386
First received: January 4, 2013
Last updated: November 30, 2015
Last verified: November 2015
  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. 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).

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:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Percent Change in Body Weight From Baseline (Day 1) to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Absolute Change in Body Weight From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Waist Circumference From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting Triglycerides From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Heart Rate From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change Fasting Insulin From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
  • Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose * Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.

  • Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.

  • Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.

  • Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26 [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ]
    Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.


Enrollment: 242
Study Start Date: February 2013
Study Completion Date: September 2014
Primary Completion Date: September 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)

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.

Behavioral: Usual Care
Usual Care is a self-directed lifestyle intervention program

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01764386     History of Changes
Other Study ID Numbers: NB-404 
Study First Received: January 4, 2013
Results First Received: September 7, 2015
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
obesity, overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Naltrexone
Bupropion
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016