Obesity, Overweight
Conditions
Keywords
obesity, overweight
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).
Interventions
DRUGNB
Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
BEHAVIORALCLI
The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.
BEHAVIORALUsual Care
Usual Care is a self-directed lifestyle intervention program
Sponsors
Orexigen Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Body Weight From Baseline (Day 1) to Week 26 | Baseline to Week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26 | Baseline to Week 26 | — |
| Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26 | Baseline to Week 26 | — |
| Absolute Change in Body Weight From Baseline to Week 26 | Baseline to Week 26 | — |
| Change in Waist Circumference From Baseline to Week 26 | Baseline to Week 26 | — |
| Change in Fasting Triglycerides From Baseline to Week 26 | Baseline to Week 26 | — |
| Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26 | Baseline to Week 26 | — |
| Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26 | Baseline to Week 26 | — |
| Change in Systolic Blood Pressure From Baseline to Week 26 | Baseline to Week 26 | — |
| Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26 | Baseline to Week 26 | — |
| Change in Heart Rate From Baseline to Week 26 | Baseline to Week 26 | — |
| Change in Fasting Plasma Glucose From Baseline to Week 26 | Baseline to Week 26 | — |
| Change Fasting Insulin From Baseline to Week 26 | Baseline to Week 26 | — |
| Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26 | 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. |
| Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26 | 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. |
| Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26 | 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. |
| Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26 | 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. |
| Change in Diastolic Blood Pressure From Baseline to Week 26 | Baseline to Week 26 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 153 |
| 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. | 89 |
| Total | 242 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Controlled Treatment Period (CTP) | Adverse Event | 35 | 0 |
| Controlled Treatment Period (CTP) | Lost to Follow-up | 9 | 5 |
| Controlled Treatment Period (CTP) | Withdrawal of Consent,Protocol Deviation | 6 | 2 |
| Controlled Treatment Period (CTP) | Wk 16 Efficacy and BP Criteria | 32 | 0 |
| Uncontrolled Treatment Period (UTP) | Adverse Event | 2 | 13 |
| Uncontrolled Treatment Period (UTP) | Lost to Follow-up | 9 | 9 |
| Uncontrolled Treatment Period (UTP) | Withdrawal of Consent,Protocol Deviation | 5 | 5 |
| Uncontrolled Treatment Period (UTP) | Wk 42 Efficacy and BP Criteria | 0 | 26 |
Baseline characteristics
| Characteristic | NB + CLI | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 9.66 | 47.0 years STANDARD_DEVIATION 9.98 | 46.5 years STANDARD_DEVIATION 9.77 |
| Baseline BMI | 36.33 kg/m^2 STANDARD_DEVIATION 4.2 | 36.26 kg/m^2 STANDARD_DEVIATION 4.369 | 36.31 kg/m^2 STANDARD_DEVIATION 4.254 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 84 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 24 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 124 Participants | 64 Participants | 188 Participants |
| Region of Enrollment United States | 153 participants | 89 participants | 242 participants |
| Sex: Female, Male Female | 125 Participants | 77 Participants | 202 Participants |
| Sex: Female, Male Male | 28 Participants | 12 Participants | 40 Participants |
| Weight | 101.4 kg STANDARD_DEVIATION 15.09 | 100.2 kg STANDARD_DEVIATION 16.58 | 100.9 kg STANDARD_DEVIATION 15.63 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 153 | 0 / 89 | 32 / 242 |
| serious Total, serious adverse events | 1 / 153 | 0 / 89 | 2 / 242 |
Outcome results
Primary
Percent Change in Body Weight From Baseline (Day 1) to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Percent Change in Body Weight From Baseline (Day 1) to Week 26 | -9.46 percent change in body weight | Standard Error 0.54 |
| Usual Care | Percent Change in Body Weight From Baseline (Day 1) to Week 26 | -0.94 percent change in body weight | Standard Error 0.49 |
p-value: <0.000195% CI: [-9.88, -7.15]ANCOVA
Secondary
Absolute Change in Body Weight From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Absolute Change in Body Weight From Baseline to Week 26 | -9.7 kg | Standard Error 0.56 |
| Usual Care | Absolute Change in Body Weight From Baseline to Week 26 | -1.0 kg | Standard Error 0.51 |
p-value: <0.000195% CI: [-10.07, -7.24]ANCOVA
Secondary
Change Fasting Insulin From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change Fasting Insulin From Baseline to Week 26 | -7.5 uIU/mL | Standard Error 0.79 |
| Usual Care | Change Fasting Insulin From Baseline to Week 26 | -3.4 uIU/mL | Standard Error 0.76 |
p-value: 0.000495% CI: [-6.2, -2]ANCOVA
Secondary
Change in Diastolic Blood Pressure From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Diastolic Blood Pressure From Baseline to Week 26 | -1.7 mm Hg | Standard Error 0.83 |
| Usual Care | Change in Diastolic Blood Pressure From Baseline to Week 26 | -1.3 mm Hg | Standard Error 0.77 |
p-value: 0.71695% CI: [-2.6, 1.8]ANCOVA
Secondary
Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26 | 4.1 mg/dL | Standard Error 0.77 |
| Usual Care | Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26 | 0.1 mg/dL | Standard Error 0.73 |
p-value: 0.000195% CI: [1.99, 6.06]ANCOVA
Secondary
Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26 | -2.0 mg/dL | Standard Error 2.2 |
| Usual Care | Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26 | -1.9 mg/dL | Standard Error 2.11 |
p-value: 0.968695% CI: [-5.96, 5.73]ANCOVA
Secondary
Change in Fasting Plasma Glucose From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Fasting Plasma Glucose From Baseline to Week 26 | -2.9 mg/dL | Standard Error 1.04 |
| Usual Care | Change in Fasting Plasma Glucose From Baseline to Week 26 | 1.6 mg/dL | Standard Error 0.96 |
p-value: 0.001695% CI: [-7.2, -1.7]ANCOVA
Secondary
Change in Fasting Triglycerides From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Fasting Triglycerides From Baseline to Week 26 | -13.6 mg/dL | Standard Error 4.96 |
| Usual Care | Change in Fasting Triglycerides From Baseline to Week 26 | 2.8 mg/dL | Standard Error 4.63 |
p-value: 0.001995% CI: [-29.5, -3.3]ANCOVA
Secondary
Change in Heart Rate From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Heart Rate From Baseline to Week 26 | 1.7 bpm | Standard Error 0.88 |
| Usual Care | Change in Heart Rate From Baseline to Week 26 | -0.3 bpm | Standard Error 0.82 |
p-value: 0.091395% CI: [-0.3, 4.3]ANCOVA
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.
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26 | -2.0 units on a scale | Standard Error 0.2 |
| Usual Care | Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26 | -0.8 units on a scale | Standard Error 0.19 |
p-value: 0.000395% CI: [-1.7, -0.7]ANCOVA
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.
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26 | -2.2 units on a scale | Standard Error 0.36 |
| Usual Care | Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26 | -0.1 units on a scale | Standard Error 0.34 |
p-value: <0.000195% CI: [-3.1, -1.1]ANCOVA
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.
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26 | -6.8 units on a scale | Standard Error 0.72 |
| Usual Care | Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26 | 1.1 units on a scale | Standard Error 0.67 |
p-value: <0.000195% CI: [-9.8, -6]ANCOVA
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.
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26 | 16.4 units on a scale | Standard Error 1.5 |
| Usual Care | Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26 | -1.0 units on a scale | Standard Error 1.41 |
p-value: <0.000195% CI: [13.45, 21.36]ANCOVA
Secondary
Change in Systolic Blood Pressure From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Systolic Blood Pressure From Baseline to Week 26 | -4.8 mm Hg | Standard Error 1.1 |
| Usual Care | Change in Systolic Blood Pressure From Baseline to Week 26 | -2.8 mm Hg | Standard Error 1.02 |
p-value: 0.170695% CI: [-4.9, 0.9]ANCOVA
Secondary
Change in Waist Circumference From Baseline to Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NB + CLI | Change in Waist Circumference From Baseline to Week 26 | -6.96 cm | Standard Error 0.705 |
| Usual Care | Change in Waist Circumference From Baseline to Week 26 | -1.64 cm | Standard Error 0.659 |
p-value: <0.000195% CI: [-7.14, -3.5]ANCOVA
Secondary
Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NB + CLI | Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26 | 42.3 percentage of participants |
| Usual Care | Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26 | 3.7 percentage of participants |
p-value: <0.000195% CI: [6, 76.7]Regression, Logistic
Secondary
Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NB + CLI | Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26 | 12.7 percentage of participants |
| Usual Care | Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26 | 0.0 percentage of participants |
Secondary
Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26
Time frame: Baseline to Week 26
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NB + CLI | Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26 | 84.5 percentage of participants |
| Usual Care | Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26 | 12.2 percentage of participants |
p-value: <0.000195% CI: [16.6, 116.3]Regression, Logistic