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

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764386
• Other study ID #: NB-404
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2013
• Last updated: November 30, 2015
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: Orexigen Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

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 is a self-directed lifestyle intervention program

Locations

Country	Name	City	State
United States	Radiant Research-Akron	Akron	Ohio
United States	Radiant Research	Anderson	South Carolina
United States	PMG Research of Bristol	Bristol	Tennessee
United States	PMG Research of Raleigh	Cary	North Carolina
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Radiant Research Dallas-North	Dallas	Texas
United States	Radiant Research	Denver	Colorado
United States	Radiant Research, Greer	Greer	South Carolina
United States	PMG Research of Winston-Salem	Hickory	North Carolina
United States	PMG Research of Charleston	Mount Pleasant	South Carolina
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	Radiant Research, Inc.	Saint Louis	Missouri
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Radiant Research, SLC	Salt Lake City	Utah
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Orexigen Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Body Weight From Baseline (Day 1) to Week 26		Baseline to Week 26	No
Secondary	Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26		Baseline to Week 26	No
Secondary	Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26		Baseline to Week 26	No
Secondary	Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26		Baseline to Week 26	No
Secondary	Absolute Change in Body Weight From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Waist Circumference From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Fasting Triglycerides From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Systolic Blood Pressure From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Diastolic Blood Pressure From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Heart Rate From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Fasting Plasma Glucose From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change Fasting Insulin From Baseline to Week 26		Baseline to Week 26	No
Secondary	Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26	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.	Baseline to Week 26	No
Secondary	Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26	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.	Baseline to Week 26	No
Secondary	Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26	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.	Baseline to Week 26	No
Secondary	Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26	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.	Baseline to Week 26	No