Obesity
Conditions
Brief summary
Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.
Interventions
DEVICEBioEnterics® Intragastric Balloon
Inflatable balloon inserted into the stomach.
Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Sponsors
Apollo Endosurgery, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have a BMI ≥ 30 and ≤ 40; * Be male or female, between 18 and 65 years of age, inclusive; * Have a history of obesity (BMI ≥ 30 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs; * Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet; * Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 26 weeks); * Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing; * Must be willing to take prescribed proton pump inhibitors (PPIs)and other medications as prescribed by the investigator; * Be able to provide written informed consent and authorization for use and release of Health and Research Study Information; * Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.
Exclusion criteria
* Any surgery of the foregut excluding uncomplicated cholecystectomy * History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy), GI obstruction, adhesive peritonitis, and/or hiatal hernia (\>/= 2 cm); * A patulous pyloric channel; * History or symptoms of esophageal or GI motility disorders (not just those with \<40%) as these patients are particularly susceptible to the development of esophagitis; * History or previous symptoms of delayed Gastric Emptying (GE) and/or delayed GE having been documented on a previously performed gastric scintigraphy study or another previously performed diagnostic study such as a UGI x-ray series; * Current symptoms of delayed GE; * A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation); * Anemia defined as a hemoglobin value for females of \<11.3 g/dl and for males \< 13.0 g/dl; * History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease; * History or symptoms of inflammatory bowel disease, such as Crohn's disease or Ulcerative Colitis; * History or symptoms of uncontrolled or unstable thyroid disease; * Subjects with a positive test for Helicobacter pylori (H.p.) at screening; subjects may participate in the study if, prior to randomization, they are treated with a pharmacological regimen designed to eradicate their H.p. and subsequently have a negative H.p. breath test indicating that the H.p. has been eradicated * History or symptoms in the past 24 months of significant irritable bowel syndrome, peritonitis, active esophagitis, gastritis and/or duodenitis, gastric or duodenal ulceration, GI hemorrhage, or GI bleeding; * Type I diabetes; * Placement of previous intragastric balloon or similar device; * Ongoing treatment with anticoagulants, steroids, aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastroduodenal mucosal irritants or to reduce GI motility, and/or an unwillingness to discontinue the use of these concomitant medications; * Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study; * Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia; * Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential; * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study; * Poor general health, presence of a specific condition, or is in a situation, which in the Evaluating and/or Placing Investigator's opinion may put the subject at significant risk, may confound the study results, may increase the risks associated with endoscopy and/or placement of the BIB, or may interfere significantly with the subject's participation in the study (e.g., HIV, Hepatitis C, or cancer history within the last 5 years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Excess Weight Loss (%EWL) | 9 months | The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight. |
| Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group | 9 months | The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) \* 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Comorbid Conditions | Baseline, Week 26, Week 39, Week 52 | The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline. Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL. Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic. Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL \<50 mg/dL (male) or \<40 mg/dL (female). |
| Change in Quality of Life (SF-36) | Baseline, Week 39 | The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores. |
| Change in Quality of Life (IWQOL-Lite) | Baseline, Week 26, Week 39, Week 52 | The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints. |
| Change in Participant Depression (Beck Depression Inventory II) | Baseline, Week 26, Week 39, Week 52 | Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion). |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at 15 investigational sites across the US, between 6/20/2008 and 10/10/2010. Patients were either enrolled as run-in subjects (mentored cases which were enrolled prior to randomized subjects in order for physicians to gain experience with placing and removing the device) or as subjects for randomization.
Pre-assignment details
448 subjects were enrolled (defined as signing the informed consent), 44 of which were run-in subjects. Prior to randomization, 131 subjects were screen failures. 273 subjects were randomized to the BIB (137) and control groups (136). 12 BIB and 6 control subjects discontinued prior to treatment. 125 BIB and 130 control subjects began treatment.
Participants by arm
| Arm | Count |
|---|---|
| BIB® Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise | 125 |
| Control Control arm receives the Behavioral modification intervention only.
Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise | 130 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 1 |
| Overall Study | Lost to Follow-up | 14 | 16 |
| Overall Study | Subject withdrew (reason not specified) | 2 | 7 |
| Overall Study | Withdrawal by Subject | 3 | 13 |
Baseline characteristics
| Characteristic | BIB® | Control | Total |
|---|---|---|---|
| Age, Customized 18-19 years | 1 participants | 0 participants | 1 participants |
| Age, Customized 20-29 years | 21 participants | 18 participants | 39 participants |
| Age, Customized 30-39 years | 49 participants | 37 participants | 86 participants |
| Age, Customized 40-49 years | 31 participants | 54 participants | 85 participants |
| Age, Customized 50-59 years | 22 participants | 16 participants | 38 participants |
| Age, Customized 60 years & over | 1 participants | 5 participants | 6 participants |
| BMI BMI <30 | 2 participants | 1 participants | 3 participants |
| BMI BMI ≥30 and <35 | 63 participants | 57 participants | 120 participants |
| BMI BMI ≥35 and ≤40 | 56 participants | 70 participants | 126 participants |
| BMI BMI >40 | 4 participants | 2 participants | 6 participants |
| Number of Years Obese 10-19 years obese | 38 participants | 51 participants | 89 participants |
| Number of Years Obese 20-29 years obese | 18 participants | 19 participants | 37 participants |
| Number of Years Obese 30-39 years obese | 10 participants | 6 participants | 16 participants |
| Number of Years Obese 40-49 years obese | 1 participants | 4 participants | 5 participants |
| Number of Years Obese 50 years obese & over | 0 participants | 0 participants | 0 participants |
| Number of Years Obese 5-9 years obese | 35 participants | 26 participants | 61 participants |
| Number of Years Obese < 5 years obese | 20 participants | 22 participants | 42 participants |
| Number of Years Obese Unknown | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black (not of Hispanic origin) | 14 participants | 15 participants | 29 participants |
| Race/Ethnicity, Customized Caucasian | 101 participants | 106 participants | 207 participants |
| Race/Ethnicity, Customized Hispanic | 9 participants | 7 participants | 16 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 112 Participants | 117 Participants | 229 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 124 / 125 | 92 / 130 |
| serious Total, serious adverse events | 19 / 125 | 8 / 130 |
Outcome results
Primary
Mean Percent Excess Weight Loss (%EWL)
The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.
Time frame: 9 months
Population: Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIB® | Mean Percent Excess Weight Loss (%EWL) | 26.52 percentage of EWL | Standard Deviation 20.7 |
| Control | Mean Percent Excess Weight Loss (%EWL) | 9.67 percentage of EWL | Standard Deviation 15.11 |
Primary
Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group
The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) \* 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.
Time frame: 9 months
Population: Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIB® | Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group | 15% EWL over the control group mean | 45.60 percentage of BIB participants |
| BIB® | Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group | 25% EWL over the control group mean | 32.8 percentage of BIB participants |
Secondary
Change in Participant Depression (Beck Depression Inventory II)
Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).
Time frame: Baseline, Week 26, Week 39, Week 52
Population: Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIB® | Change in Participant Depression (Beck Depression Inventory II) | Baseline (BIB n=124, Control n=130) | 7.7 units on a scale | Standard Deviation 7.92 |
| BIB® | Change in Participant Depression (Beck Depression Inventory II) | Week 26 (BIB n=104, Control n=95) | 3.7 units on a scale | Standard Deviation 4.83 |
| BIB® | Change in Participant Depression (Beck Depression Inventory II) | Week 39 (BIB n=99, Control n=93) | 3.6 units on a scale | Standard Deviation 5.12 |
| BIB® | Change in Participant Depression (Beck Depression Inventory II) | Week 52 (BIB n=97, Control n=95) | 3.9 units on a scale | Standard Deviation 6.42 |
| Control | Change in Participant Depression (Beck Depression Inventory II) | Week 52 (BIB n=97, Control n=95) | 5.7 units on a scale | Standard Deviation 7.3 |
| Control | Change in Participant Depression (Beck Depression Inventory II) | Baseline (BIB n=124, Control n=130) | 8.4 units on a scale | Standard Deviation 7.79 |
| Control | Change in Participant Depression (Beck Depression Inventory II) | Week 39 (BIB n=99, Control n=93) | 6.3 units on a scale | Standard Deviation 6.68 |
| Control | Change in Participant Depression (Beck Depression Inventory II) | Week 26 (BIB n=104, Control n=95) | 7.0 units on a scale | Standard Deviation 8.3 |
Secondary
Change in Quality of Life (IWQOL-Lite)
The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.
Time frame: Baseline, Week 26, Week 39, Week 52
Population: Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIB® | Change in Quality of Life (IWQOL-Lite) | Baseline (BIB n=121, Control n=127) | 68.40 units on a scale | Standard Deviation 18.733 |
| BIB® | Change in Quality of Life (IWQOL-Lite) | Week 39 (BIB n=99, Control n=93) | 85.78 units on a scale | Standard Deviation 14.411 |
| BIB® | Change in Quality of Life (IWQOL-Lite) | Week 26 (BIB n=103, Control n=94) | 84.64 units on a scale | Standard Deviation 12.888 |
| BIB® | Change in Quality of Life (IWQOL-Lite) | Week 52 (BIB n=97, Control n=94) | 85.79 units on a scale | Standard Deviation 15.424 |
| Control | Change in Quality of Life (IWQOL-Lite) | Week 26 (BIB n=103, Control n=94) | 76.67 units on a scale | Standard Deviation 16.472 |
| Control | Change in Quality of Life (IWQOL-Lite) | Baseline (BIB n=121, Control n=127) | 68.55 units on a scale | Standard Deviation 17.356 |
| Control | Change in Quality of Life (IWQOL-Lite) | Week 52 (BIB n=97, Control n=94) | 79.85 units on a scale | Standard Deviation 16.189 |
| Control | Change in Quality of Life (IWQOL-Lite) | Week 39 (BIB n=99, Control n=93) | 78.58 units on a scale | Standard Deviation 16.833 |
Secondary
Change in Quality of Life (SF-36)
The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.
Time frame: Baseline, Week 39
Population: Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIB® | Change in Quality of Life (SF-36) | Physical Func-Baseline (BIB n=122, Control n=130) | 71.4 units on a scale | Standard Deviation 22.09 |
| BIB® | Change in Quality of Life (SF-36) | Vitality-Baseline (BIB n=123, Control n=130) | 52.7 units on a scale | Standard Deviation 18.19 |
| BIB® | Change in Quality of Life (SF-36) | Bodily Pain-Baseline (BIB n=123, Control n=130) | 72.8 units on a scale | Standard Deviation 21.88 |
| BIB® | Change in Quality of Life (SF-36) | Vitality-Week 39 (BIB n=99, Control n=93) | 67.6 units on a scale | Standard Deviation 17.74 |
| BIB® | Change in Quality of Life (SF-36) | Role Physical-Baseline (BIB n=123, Control n=130) | 78.5 units on a scale | Standard Deviation 21.59 |
| BIB® | Change in Quality of Life (SF-36) | Social Func-Baseline (BIB n=123, Control n=130) | 80.5 units on a scale | Standard Deviation 21.89 |
| BIB® | Change in Quality of Life (SF-36) | Bodily Pain-Week 39 (BIB n=99, Control n=93) | 84.9 units on a scale | Standard Deviation 18.84 |
| BIB® | Change in Quality of Life (SF-36) | Physical Func-Week 39 (BIB n=98, Control n=92) | 90.0 units on a scale | Standard Deviation 14.26 |
| BIB® | Change in Quality of Life (SF-36) | Role Emotional-Baseline (BIB n=123, Control n=130) | 84.0 units on a scale | Standard Deviation 22.65 |
| BIB® | Change in Quality of Life (SF-36) | General Health-Baseline (BIB n=123, Control n=128) | 61.9 units on a scale | Standard Deviation 20.22 |
| BIB® | Change in Quality of Life (SF-36) | Role Emotional-Week 39 (BIB n=98, Control n=93) | 92.2 units on a scale | Standard Deviation 15.55 |
| BIB® | Change in Quality of Life (SF-36) | Role Physical-Week 39 (BIB n=98, Control n=93) | 93.0 units on a scale | Standard Deviation 13.56 |
| BIB® | Change in Quality of Life (SF-36) | Mental Health-Baseline (BIB n=123, Control n=130) | 74.0 units on a scale | Standard Deviation 17.91 |
| BIB® | Change in Quality of Life (SF-36) | General Health-Week 39 (BIB n=99, Control n=93) | 79.1 units on a scale | Standard Deviation 16.53 |
| BIB® | Change in Quality of Life (SF-36) | Mental Health-Week 39 (BIB n=99, Control n=93) | 80.1 units on a scale | Standard Deviation 15.82 |
| BIB® | Change in Quality of Life (SF-36) | Social Func-Week 39 (BIB n=99, Control n=93) | 92.6 units on a scale | Standard Deviation 13.35 |
| Control | Change in Quality of Life (SF-36) | Mental Health-Week 39 (BIB n=99, Control n=93) | 72.5 units on a scale | Standard Deviation 18.09 |
| Control | Change in Quality of Life (SF-36) | Physical Func-Baseline (BIB n=122, Control n=130) | 73.7 units on a scale | Standard Deviation 21.14 |
| Control | Change in Quality of Life (SF-36) | Physical Func-Week 39 (BIB n=98, Control n=92) | 85.4 units on a scale | Standard Deviation 15.5 |
| Control | Change in Quality of Life (SF-36) | Role Physical-Baseline (BIB n=123, Control n=130) | 80.3 units on a scale | Standard Deviation 23.07 |
| Control | Change in Quality of Life (SF-36) | Role Physical-Week 39 (BIB n=98, Control n=93) | 85.6 units on a scale | Standard Deviation 20.89 |
| Control | Change in Quality of Life (SF-36) | Bodily Pain-Baseline (BIB n=123, Control n=130) | 75.4 units on a scale | Standard Deviation 22.34 |
| Control | Change in Quality of Life (SF-36) | Bodily Pain-Week 39 (BIB n=99, Control n=93) | 76.2 units on a scale | Standard Deviation 23.91 |
| Control | Change in Quality of Life (SF-36) | General Health-Baseline (BIB n=123, Control n=128) | 63.4 units on a scale | Standard Deviation 20.11 |
| Control | Change in Quality of Life (SF-36) | General Health-Week 39 (BIB n=99, Control n=93) | 68.6 units on a scale | Standard Deviation 20.67 |
| Control | Change in Quality of Life (SF-36) | Vitality-Baseline (BIB n=123, Control n=130) | 53.0 units on a scale | Standard Deviation 19.11 |
| Control | Change in Quality of Life (SF-36) | Vitality-Week 39 (BIB n=99, Control n=93) | 58.3 units on a scale | Standard Deviation 21.08 |
| Control | Change in Quality of Life (SF-36) | Social Func-Baseline (BIB n=123, Control n=130) | 80.8 units on a scale | Standard Deviation 23.3 |
| Control | Change in Quality of Life (SF-36) | Social Func-Week 39 (BIB n=99, Control n=93) | 83.3 units on a scale | Standard Deviation 22.14 |
| Control | Change in Quality of Life (SF-36) | Role Emotional-Baseline (BIB n=123, Control n=130) | 84.6 units on a scale | Standard Deviation 20.81 |
| Control | Change in Quality of Life (SF-36) | Role Emotional-Week 39 (BIB n=98, Control n=93) | 86.8 units on a scale | Standard Deviation 19.75 |
| Control | Change in Quality of Life (SF-36) | Mental Health-Baseline (BIB n=123, Control n=130) | 73.7 units on a scale | Standard Deviation 16.6 |
Secondary
Percent of Participants With Comorbid Conditions
The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline. Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL. Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic. Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL \<50 mg/dL (male) or \<40 mg/dL (female).
Time frame: Baseline, Week 26, Week 39, Week 52
Population: Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIB® | Percent of Participants With Comorbid Conditions | Diabetes-Baseline (BIB n=124, Control n=130) | 7.3 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Diabetes-Week 26 (BIB n=100, Control n=94) | 3.0 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Diabetes-Week 39 (BIB n=102, Control n=94) | 4.9 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Diabetes-Week 52 (BIB n=95, Control n=94) | 3.2 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Hypertension-Baseline (BIB n=125, Control n=130) | 26.4 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Hypertension-Week 26 (BIB n=124, Control n=91) | 17.7 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Hypertension-Week 39 (BIB n=91, Control n=95) | 15.4 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Hypertension-Week 52 (BIB n=98, Control n=92) | 11.2 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Dyslipidemia-Baseline (BIB n=125, Control n=130) | 39.2 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Dyslipidemia-Week 26 (BIB n=102, Control n=94) | 31.4 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Dyslipidemia-Week 39 (BIB n=102, Control n=95) | 28.4 percentage of participants |
| BIB® | Percent of Participants With Comorbid Conditions | Dyslipidemia-Week 52 (BIB n=96, Control n=94) | 30.2 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Dyslipidemia-Week 39 (BIB n=102, Control n=95) | 28.4 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Diabetes-Baseline (BIB n=124, Control n=130) | 6.2 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Hypertension-Week 39 (BIB n=91, Control n=95) | 21.1 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Diabetes-Week 26 (BIB n=100, Control n=94) | 4.3 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Dyslipidemia-Week 26 (BIB n=102, Control n=94) | 27.7 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Diabetes-Week 39 (BIB n=102, Control n=94) | 3.2 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Hypertension-Week 52 (BIB n=98, Control n=92) | 22.8 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Diabetes-Week 52 (BIB n=95, Control n=94) | 5.3 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Dyslipidemia-Week 52 (BIB n=96, Control n=94) | 26.6 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Hypertension-Baseline (BIB n=125, Control n=130) | 28.5 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Dyslipidemia-Baseline (BIB n=125, Control n=130) | 30.0 percentage of participants |
| Control | Percent of Participants With Comorbid Conditions | Hypertension-Week 26 (BIB n=124, Control n=91) | 19.8 percentage of participants |
Post Hoc
Change in BMI
Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).
Time frame: Baseline, Week 26, Week 39, Week 52
Population: Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIB® | Change in BMI | Baseline (BIB n=125, Control n=130) | 35.20 kg/m² | Standard Deviation 3.165 |
| BIB® | Change in BMI | Week 26 (BIB n=117, Control n=91) | 31.43 kg/m² | Standard Deviation 3.762 |
| BIB® | Change in BMI | Week 39 (BIB n=91, Control n=95) | 31.85 kg/m² | Standard Deviation 4.035 |
| BIB® | Change in BMI | Week 52 (BIB n=98, Control n=92) | 32.50 kg/m² | Standard Deviation 4.177 |
| Control | Change in BMI | Week 52 (BIB n=98, Control n=92) | 33.96 kg/m² | Standard Deviation 3.517 |
| Control | Change in BMI | Baseline (BIB n=125, Control n=130) | 35.43 kg/m² | Standard Deviation 2.65 |
| Control | Change in BMI | Week 39 (BIB n=91, Control n=95) | 33.83 kg/m² | Standard Deviation 3.3 |
| Control | Change in BMI | Week 26 (BIB n=117, Control n=91) | 33.61 kg/m² | Standard Deviation 3.253 |
Post Hoc
Percent EWL (Using BMI=25 kg/m²)
Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion). Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25.
Time frame: Baseline, Week 26, Week 39, Week 52
Population: Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIB® | Percent EWL (Using BMI=25 kg/m²) | Week 26 (BIB n=117, Control n=91) | 38.4 percentage of EWL | Standard Deviation 27.61 |
| BIB® | Percent EWL (Using BMI=25 kg/m²) | Week 39 (BIB n=91, Control n=95) | 34.6 percentage of EWL | Standard Deviation 28.4 |
| BIB® | Percent EWL (Using BMI=25 kg/m²) | Week 52 (BIB n=98, Control n=92) | 29.0 percentage of EWL | Standard Deviation 30.7 |
| Control | Percent EWL (Using BMI=25 kg/m²) | Week 26 (BIB n=117, Control n=91) | 12.1 percentage of EWL | Standard Deviation 18.58 |
| Control | Percent EWL (Using BMI=25 kg/m²) | Week 39 (BIB n=91, Control n=95) | 12.3 percentage of EWL | Standard Deviation 19.33 |
| Control | Percent EWL (Using BMI=25 kg/m²) | Week 52 (BIB n=98, Control n=92) | 11.1 percentage of EWL | Standard Deviation 20.67 |
Post Hoc
Percent Total Body Weight Loss (%TBWL)
Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).
Time frame: Baseline, Week 26, Week 39, Week 52
Population: Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| BIB® | Percent Total Body Weight Loss (%TBWL) | Week 26 (BIB n=117, Control n=91) | 10.2 percentage of TBWL |
| BIB® | Percent Total Body Weight Loss (%TBWL) | Week 39 (BIB n=91, Control n=93)5 | 9.1 percentage of TBWL |
| BIB® | Percent Total Body Weight Loss (%TBWL) | Week 52 (BIB n=98, Control n=92) | 7.6 percentage of TBWL |
| Control | Percent Total Body Weight Loss (%TBWL) | Week 26 (BIB n=117, Control n=91) | 3.3 percentage of TBWL |
| Control | Percent Total Body Weight Loss (%TBWL) | Week 39 (BIB n=91, Control n=93)5 | 3.4 percentage of TBWL |
| Control | Percent Total Body Weight Loss (%TBWL) | Week 52 (BIB n=98, Control n=92) | 3.1 percentage of TBWL |