Obesity
Conditions
Keywords
obesity, weight loss
Brief summary
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.
Interventions
Sponsors
ReShape Lifesciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients 21 to 60 years of age * Body Mass Index (BMI) ≥ 30 kg/m\^2 and ≤ 40 kg/m\^2 * At least 5 years of obesity (with BMI ≥ 30) * Stable weight, defined as a subject who has not gained or lost ≥ 5% of body weight in the 3 months preceding the screening assessment * Failure to lose weight, within the 36 months preceding the screening date, after participation in either of the following: 1. A medically or commercially supervised weight loss program involving regular counseling regarding both diet and exercise. 2. Use of a United States Food and Drug Administration (FDA)-approved diet drug * The presence of one or more obesity-related comorbid conditions * Willing and able to provide Informed Consent * Willing and able to comply with study procedures and visit schedules as specified by the protocol * If female, the patient must 1. be postmenopausal for at least 1 year OR 2. be surgically sterile, OR 3. if of child bearing potential, must be practicing birth control, be willing to avoid pregnancy for the year of study participation, have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline * Residing within a reasonable distance from the Investigator's treating office and able and willing to travel to the Investigator's office to complete all routine follow-up visits.
Exclusion criteria
* History of and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract * Clinically significant and uncontrolled/unstable hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, psychiatric, respiratory, endocrine, or cardiovascular system diseases * Significant acute and/or chronic infections of any kind. * Severe coagulopathy, hepatic insufficiency or cirrhosis * Uncontrolled or severe asthma, or any asthma requiring or likely to require inhaled steroid therapy during the anticipated duration of trial participation * Severe obstructive sleep apnea * Incompletely controlled hypothyroidism or hyperthyroidism * Severe systemic disease \[consistent with an ASA (American Society of Anesthesia) Physical Status Classification Score of 3 or greater\] * Eating disorders, especially binge eating * Inability to walk 200 yards without assistance * Known allergies to any of the device materials or accessories, i.e. silicone, methylene blue, corn starch * Active drug or alcohol addiction within 12 months of enrollment * Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months * Depressive disorder with total Beck Depression Inventory (BDI) score \> 16 points, and/or BDI affective subscale score \> 7 points at screening * Ongoing treatment, or anticipated need for such treatment, with anticoagulants, known gastric irritants such as aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) or agents that can promote gastrointestinal bleeding, within 1 month prior to enrollment, or unwillingness to forego these medications during the study period * Participation within 60 days of screening date in previous or ongoing clinical trial or current usage of an investigational drug or device * Any use of an intragastric device prior to this study. * Genetically caused obesity, such as Prader-Willi syndrome * Any prior bariatric surgery or likely to undergo bariatric surgery during study follow-up period * Concomitant use of, or unwillingness to avoid any use of, weight loss medications, weight loss supplements, weight loss herbal preparations and/or participation in any non-study-related organized weight loss program (commercial or medical) at any time during the study, including online or smart phone applications to track or modify food intake, exercise regimens or weight * Chronic opiate use (\> 3 months continuous use) or likely need for opiate use during study participation * Contraindication or allergy to, or unwillingness to use, proton pump inhibitor medication throughout study follow-up duration-Pregnancy, breast feeding, or intention of becoming pregnant during the study * Any screening laboratory values outside of the normal range deemed clinically significant by the Investigator * Anemia defined as either: 1. Hemoglobin (Hgb) value for females of \< 11.0 g/dl, for males \< 12.0 g/dl 2. Abnormal red cell indices and iron deficiency * Smoking cessation within 3 months of study entry or plans to quit smoking during the study * Major surgery, open biopsy or significant traumatic injury within 3 months prior to enrollment. * History of significant adverse experience with sedation or anesthesia * Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with study procedures * Any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements, including: 1. Inability or unwillingness to sign the patient informed consent document. 2. Inability to participate in all necessary study activities due to physical or mental limitations. 3. Inability or unwillingness to return for all required follow-up visits. * Employees/family members of ReShape Medical® or any of its affiliates or contractors * Employees/family members of the Investigator, sub-Investigators, or their medical office or practice, or surgical, bariatric or hospital organizations at which study procedures may be performed * An immediate family member (by marriage or blood relationship) of another subject already enrolled in the REDUCE Pivotal Trial Endoscopic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24 | Week 24 | An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%. |
| Treatment Group Responder Rate Dichotomized at 25% EWL | 24 weeks | An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of \>25% EWL at 24 weeks was significantly greater than 35%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss Maintenance Six Months Following Device Removal | 48 weeks | Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ReShape Duo Balloon ReShape Duo Balloon
ReShape Duo balloon
Diet counseling
Exercise counseling | 187 |
| Sham Comparator Sham Comparator
Diet counseling
Exercise counseling | 139 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 51 | 13 |
Baseline characteristics
| Characteristic | Sham Comparator | ReShape Duo Balloon | Total |
|---|---|---|---|
| Age, Continuous | 44.04 years STANDARD_DEVIATION 10.17 | 43.77 years STANDARD_DEVIATION 9.51 | 43.88 years STANDARD_DEVIATION 9.78 |
| BMI | 35.43 kg/m^2 STANDARD_DEVIATION 2.63 | 35.32 kg/m^2 STANDARD_DEVIATION 2.84 | 35.37 kg/m^2 STANDARD_DEVIATION 2.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 15 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 172 Participants | 303 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 25 Participants | 41 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 | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) White | 118 Participants | 153 Participants | 271 Participants |
| Sex: Female, Male Female | 132 Participants | 178 Participants | 310 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 186 / 187 | 87 / 139 |
| serious Total, serious adverse events | 25 / 187 | 6 / 139 |
Outcome results
Primary
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24 | 25.1 percentage of EWL | Standard Error 1.596 |
| Control | Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24 | 11.3 percentage of EWL | Standard Error 1.881 |
p-value: 0.0041t-test, 1 sided
Primary
Treatment Group Responder Rate Dichotomized at 25% EWL
An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of \>25% EWL at 24 weeks was significantly greater than 35%.
Time frame: 24 weeks
Population: By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Treatment Group Responder Rate Dichotomized at 25% EWL | 48.8 percentage of participants |
p-value: <0.0001t-test, 1 sided
Secondary
Weight Loss Maintenance Six Months Following Device Removal
Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.
Time frame: 48 weeks
Population: By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Weight Loss Maintenance Six Months Following Device Removal | 49.4 percentage of participant |
p-value: 0.561Chi-squared