| Primary | Percent Change in Body Weight From Baseline (Day 1) to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | percent change in body weight | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-9.46± 0.54
- OG001-0.94± 0.49
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | <0.0001 | | Mean Difference (Net) | -8.52 | | | 2-Sided | 95 | -9.88 | -7.15 | | | | No | Superiority or Other | | |
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| Secondary | Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Number | | percentage of participants | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Number | | percentage of participants | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Number | | percentage of participants | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Absolute Change in Body Weight From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | kg | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Waist Circumference From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | cm | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Fasting Triglycerides From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | mm Hg | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Diastolic Blood Pressure From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | mm Hg | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Heart Rate From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | bpm | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change in Fasting Plasma Glucose From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| Secondary | Change Fasting Insulin From Baseline to Week 26 | | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | uIU/mL | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
| |
| 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. | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
|
| 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. | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
|
| 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. | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
|
| 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. | The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | NB + CLI | Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI) NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage) CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools. | | OG001 | 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. |
|