Obesity
Conditions
Keywords
Roux-en-Y gastric bypass (RYGB)
Brief summary
This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.
Detailed description
The specific aims of this study are to: * To evaluate the effects of liraglutide on body weight loss in patients who are experiencing weight regain following RYGB. * To evaluate the effects of liraglutide on cardiometabolic risk and quality of life in patients who are experiencing weight regain following RYGB. * To evaluate the safety of liraglutide in post-RYGB subjects. * To evaluate the changes in obesity-related comorbid conditions in patients who are experiencing weight regain following RYGB.
Interventions
DRUGSaxenda
Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day
DRUGPlacebo
Subcutaneous Saline Solution
Sponsors
Novo Nordisk A/S
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Randomization will be 2:1 (drug:placebo) with stratification by gender and percent post-operative TBWL (25%, 25 - 49.9%).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 months status-post RYGB * BMI 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition * BMI 30 kg/m2 or greater * Regain of ≥10% of maximum TBWL post-RYGB * Ability to provide informed consent before any trial-related activities * Express willingness to follow protocol requirements
Exclusion criteria
* Pregnancy at time of enrollment * Intention of becoming pregnant or breast feeding in the next 12 months * Females of childbearing potential who are not using adequate contraceptive methods * Presence of acute psychiatric problems or immaturity which would compromise cooperation with the study protocol * Presence of biliary disease * Known or suspected allergy to liraglutide or any product components * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * History of pancreatitis * History of alcoholism * History of Type 1 DM (Diabetes Mellitus) * History of previous bariatric surgery other than RYGB except h/o LAGB and band removal. * \>10 years status-post RYGB * \< 25% TBWL at post-RYGB weight nadir * \>50% post-operative TBWL at time of screening * Simultaneous use of any weight loss medications * Use of insulin at the time of enrollment * Current use of any GLP-1 agonist medication * History of taking any GLP-1 agonist medication * Participation in another ongoing clinical study * Conditions that, in the opinion of the principal investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test | 12 Months | CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saxenda Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day
Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day | 58 |
| Placebo Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day
Placebo: Subcutaneous Saline Solution | 23 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 22 | 10 |
| Overall Study | Terminated | 3 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Saxenda | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 8.9 | 49.7 years STANDARD_DEVIATION 9.8 | 50.4 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 11 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 70 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 23 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 45 Participants | 13 Participants |
| Region of Enrollment United States | 58 participants | 81 participants | 23 participants |
| Sex: Female, Male Female | 49 Participants | 69 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 43 |
| other Total, other adverse events | 40 / 89 | 26 / 43 |
| serious Total, serious adverse events | 4 / 89 | 6 / 43 |
Outcome results
Primary
Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test
CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxenda | Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test | 76 percentage of participants |
| Placebo | Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test | 17 percentage of participants |