Trial Outcomes & Findings for 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 (NCT NCT01764386)
NCT ID: NCT01764386
Last Updated: 2015-12-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2015-12-29
Participant Flow
Participant milestones
| Measure |
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.
The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78).
|
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.
The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78).
|
|---|---|---|
|
Controlled Treatment Period (CTP)
STARTED
|
153
|
89
|
|
Controlled Treatment Period (CTP)
COMPLETED
|
71
|
82
|
|
Controlled Treatment Period (CTP)
NOT COMPLETED
|
82
|
7
|
|
Uncontrolled Treatment Period (UTP)
STARTED
|
71
|
81
|
|
Uncontrolled Treatment Period (UTP)
Completed 52 Weeks
|
61
|
35
|
|
Uncontrolled Treatment Period (UTP)
COMPLETED
|
55
|
28
|
|
Uncontrolled Treatment Period (UTP)
NOT COMPLETED
|
16
|
53
|
Reasons for withdrawal
| Measure |
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.
The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78).
|
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.
The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78).
|
|---|---|---|
|
Controlled Treatment Period (CTP)
Adverse Event
|
35
|
0
|
|
Controlled Treatment Period (CTP)
Wk 16 Efficacy and BP Criteria
|
32
|
0
|
|
Controlled Treatment Period (CTP)
Lost to Follow-up
|
9
|
5
|
|
Controlled Treatment Period (CTP)
Withdrawal of Consent,Protocol Deviation
|
6
|
2
|
|
Uncontrolled Treatment Period (UTP)
Adverse Event
|
2
|
13
|
|
Uncontrolled Treatment Period (UTP)
Wk 42 Efficacy and BP Criteria
|
0
|
26
|
|
Uncontrolled Treatment Period (UTP)
Lost to Follow-up
|
9
|
9
|
|
Uncontrolled Treatment Period (UTP)
Withdrawal of Consent,Protocol Deviation
|
5
|
5
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
NB + CLI
n=153 Participants
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.
|
Usual Care
n=89 Participants
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.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 9.98 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=5 Participants
|
89 participants
n=7 Participants
|
242 participants
n=5 Participants
|
|
Weight
|
101.4 kg
STANDARD_DEVIATION 15.09 • n=5 Participants
|
100.2 kg
STANDARD_DEVIATION 16.58 • n=7 Participants
|
100.9 kg
STANDARD_DEVIATION 15.63 • n=5 Participants
|
|
Baseline BMI
|
36.33 kg/m^2
STANDARD_DEVIATION 4.200 • n=5 Participants
|
36.26 kg/m^2
STANDARD_DEVIATION 4.369 • n=7 Participants
|
36.31 kg/m^2
STANDARD_DEVIATION 4.254 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Percent Change in Body Weight From Baseline (Day 1) to Week 26
|
-9.46 percent change in body weight
Standard Error 0.54
|
-0.94 percent change in body weight
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26
|
84.5 percentage of participants
|
12.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26
|
42.3 percentage of participants
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26
|
12.7 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Absolute Change in Body Weight From Baseline to Week 26
|
-9.7 kg
Standard Error 0.56
|
-1.0 kg
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Waist Circumference From Baseline to Week 26
|
-6.96 cm
Standard Error 0.705
|
-1.64 cm
Standard Error 0.659
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Fasting Triglycerides From Baseline to Week 26
|
-13.6 mg/dL
Standard Error 4.96
|
2.8 mg/dL
Standard Error 4.63
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26
|
-2.0 mg/dL
Standard Error 2.20
|
-1.9 mg/dL
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26
|
4.1 mg/dL
Standard Error 0.77
|
0.1 mg/dL
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to Week 26
|
-4.8 mm Hg
Standard Error 1.10
|
-2.8 mm Hg
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to Week 26
|
-1.7 mm Hg
Standard Error 0.83
|
-1.3 mm Hg
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Heart Rate From Baseline to Week 26
|
1.7 bpm
Standard Error 0.88
|
-0.3 bpm
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline to Week 26
|
-2.9 mg/dL
Standard Error 1.04
|
1.6 mg/dL
Standard Error 0.96
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change Fasting Insulin From Baseline to Week 26
|
-7.5 uIU/mL
Standard Error 0.79
|
-3.4 uIU/mL
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26
|
-2.0 units on a scale
Standard Error 0.20
|
-0.8 units on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
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
|
1.1 units on a scale
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
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
|
-0.1 units on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: 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.
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.
Outcome measures
| Measure |
NB + CLI
n=71 Participants
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.
|
Usual Care
n=82 Participants
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.
|
|---|---|---|
|
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 1.50
|
-1.0 units on a scale
Standard Error 1.41
|
Adverse Events
NB + CLI (Controlled Treatment Period)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Usual Care (Controlled Treatment Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Subjects (Entire Study)
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NB + CLI (Controlled Treatment Period)
n=153 participants at risk
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.
The Controlled Treatment Period was from Day 1 to Week 26.
|
Usual Care (Controlled Treatment Period)
n=89 participants at risk
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.
The Controlled Treatment Period was from Day 1 to Week 26.
|
All Subjects (Entire Study)
n=242 participants at risk
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.
All Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.65%
1/153 • Number of events 1 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.00%
0/89 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.83%
2/242 • Number of events 2 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
Other adverse events
| Measure |
NB + CLI (Controlled Treatment Period)
n=153 participants at risk
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.
The Controlled Treatment Period was from Day 1 to Week 26.
|
Usual Care (Controlled Treatment Period)
n=89 participants at risk
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.
The Controlled Treatment Period was from Day 1 to Week 26.
|
All Subjects (Entire Study)
n=242 participants at risk
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.
All Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.5%
16/153 • Number of events 16 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.00%
0/89 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
7.0%
17/242 • Number of events 17 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
|
Psychiatric disorders
Anxiety
|
3.3%
5/153 • Number of events 5 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.00%
0/89 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
2.1%
5/242 • Number of events 5 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
|
Nervous system disorders
Headache
|
1.3%
2/153 • Number of events 2 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.00%
0/89 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
1.7%
4/242 • Number of events 4 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
|
Psychiatric disorders
Insomnia
|
1.3%
2/153 • Number of events 2 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.00%
0/89 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
1.2%
3/242 • Number of events 3 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
|
Nervous system disorders
Dizziness
|
0.65%
1/153 • Number of events 1 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.00%
0/89 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
1.2%
3/242 • Number of events 3 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/153 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
0.00%
0/89 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
1.2%
3/242 • Number of events 3 • Day 1 through Week 78
Only serious adverse events (SAE) and treatment-emergent adverse events (TEAE) leading to discontinuation from full participation were collected in this study. The 1% frequency threshold for reporting other adverse events is based on All Subjects (Entire Study) column.
|
Additional Information
Executive Vice President, Head of Global Development
Orexigen Therapeutics, Inc.
Phone: (858) 875-8600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If not already published by Sponsor as part of a multi-center publication, 24 months after conclusion, abandonment or termination of the study or notification that there will be no such multi-center publication, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 90 days to review and comment on the proposed publication. Sponsor may delay publication for up to an additional 6 month period to file for patent protection.
- Publication restrictions are in place
Restriction type: OTHER