Obesity
Conditions
Keywords
Weight Loss, Obesity, BMI
Brief summary
This pivotal trial of the Obalon Balloon System is intended to generate safety and effectiveness data required to support a future marketing application. The trial has been designed to evaluate a 6-month use of the Obalon Balloon System as an adjunct to a nutrition and lifestyle behavior modification program. Weight loss will be evaluated after the 6-month course to determine if a specific predefined superiority margin can be achieved in the device group compared to a sham-control group.
Interventions
DEVICEObalon Intragastric Balloons
Intragastric Balloon System to aid in portion control.
DEVICESham Device
Sham Intragastric Balloon
BEHAVIORALNutrition and Lifestyle Program
Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.
Sponsors
Obalon Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between the ages of 22-64 years 2. Current BMI of 30.0 - 40 kg/m2 3. Previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet 4. Willing to attend all protocol-specified follow-up visits plus any additional follow-up visits as required throughout the entire study period 5. Willing to avoid non-commercial air travel and scuba diving during the entire study period 6. Willing to avoid medications or other substances known to effect weight changes during the study 7. Willing to avoid Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or other medications known to be gastric irritants during the study 8. Willing to use contraception and avoid pregnancy during the study if the subject is female with child bearing potential 9. Willing to provide written informed consent
Exclusion criteria
1. Significant weight loss in the past 12 months 2. Use of medications or other substances known to induce weight gain or weight loss 3. Participation in any clinical study at the start of this trial or in the last year 4. Known history of endocrine disorders affecting weight 5. Currently receiving chronic steroid or immunosuppressive therapy or has previously been diagnosed with HIV 6. Subjects diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders 7. Intent to undergo gastric surgery or gastric banding during the study period or within the 6 month period after completion of this study 8. Prior use of any weight loss medical device 9. Known history of structural or functional disorders of the esophagus 10. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms 11. Known history of structural or functional disorders of the stomach 12. Known history of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety 13. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract 14. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting 15. Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease 16. Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities 17. Type 1 diabetes 18. Type 2 diabetes requiring insulin or other hypoglycemic oral agents. 19. Experienced a myocardial infarction, has a known history of angina, a known history of congestive heart failure, or is currently being medically treated for any other cardiac condition 20. Poorly controlled hypertension, (≥ 160 mmHg Systolic and ≥ 100mmHg Diastolic). 21. End stage renal disease or requiring hemodialysis within the past 6 months 22. Unwilling or unable to avoid Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Aspirin, Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study period 23. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying 24. Subjects requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood 25. Untreated or unstable alcohol or illicit drug addiction 26. Known history of allergies to any component of the device materials 27. Currently pregnant or breastfeeding or intention of becoming pregnant during the study 28. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator 29. Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff 30. Subject is a close relative of another subject already enrolled in the study. 31. Any other condition that, in the opinion of the investigator, would interfere with subject participation, may confound the study results, or interfere with compliance with the study (e.g., psychosocial issues).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups | 24 Weeks | Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin |
| Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL) | 6 months | Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35% |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group | 6 Months | Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL) |
Countries
United States
Participant flow
Recruitment details
711 subjects signed an informed consent form to participate in the study and proceeded to the screening eligibility process
Pre-assignment details
430 subjects randomized in a Treatment or Control group, 387 subjects received an Obalon Balloon or Sham Device.
Participants by arm
| Arm | Count |
|---|---|
| Obalon Treatment Group Obalon Balloon Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks | 198 |
| Sham Control Group Sham Device with Weight Loss Behavior Modification (WLBM) Program for 24 weeks | 189 |
| Total | 387 |
Baseline characteristics
| Characteristic | Obalon Treatment Group | Sham Control Group | Total |
|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 9.6 | 42.5 years STANDARD_DEVIATION 9.3 | 42.6 years STANDARD_DEVIATION 9.4 |
| Body Mass Index (BMI) | 35.2 kg/m^2 STANDARD_DEVIATION 2.7 | 35.5 kg/m^2 STANDARD_DEVIATION 2.7 | 35.4 kg/m^2 STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 24 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants | 165 Participants | 348 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 | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 29 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 3 Participants | 14 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 | 165 Participants | 155 Participants | 320 Participants |
| Sex: Female, Male Female | 171 Participants | 170 Participants | 341 Participants |
| Sex: Female, Male Male | 27 Participants | 19 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 336 | 0 / 359 |
| other Total, other adverse events | 321 / 336 | 221 / 359 |
| serious Total, serious adverse events | 7 / 336 | 5 / 359 |
Outcome results
Primary
Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups
Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin
Time frame: 24 Weeks
Population: Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Obalon Treatment Group | Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups | 6.86 %TBL | Standard Error 0.37 |
| Sham Control Group | Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups | 3.59 %TBL | Standard Error 0.37 |
p-value: 0.026195% CI: [2.24, 4.32]ANCOVA
Primary
Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)
Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%
Time frame: 6 months
Population: Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Obalon Treatment Group | Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL) | 120 Participants |
Comparison: Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.p-value: <0.000195% CI: [57.5, 71.7]Exact Test
Other Pre-specified
Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group
Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)
Time frame: 6 Months
Population: Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Obalon Treatment Group | Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group | 120 Participants |
| Sham Control Group | Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group | 58 Participants |
p-value: <0.000195% CI: [23.1, 42.5]Chi-squared