Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: 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
Other Names:
|
Placebo Comparator: 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 |
Drug: Placebo
Subcutaneous Saline Solution
|
Outcome Measures
Primary Outcome Measures
- Proportion 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | New York University Medical Center | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- Novo Nordisk A/S
Investigators
- Principal Investigator: Holly Lofton, MD, NYU Langone Health
Study Documents (Full-Text)
More Information
Publications
None provided.- 16-01527
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Saxenda | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Period Title: Overall Study | ||
STARTED | 89 | 43 |
COMPLETED | 58 | 23 |
NOT COMPLETED | 31 | 20 |
Baseline Characteristics
Arm/Group Title | Saxenda | Placebo | Total |
---|---|---|---|
Arm/Group Description | 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 | 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 | Total of all reporting groups |
Overall Participants | 58 | 23 | 81 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
49.4
(8.9)
|
50.4
(11.9)
|
49.7
(9.8)
|
Sex: Female, Male (Count of Participants) | |||
Female |
49
84.5%
|
20
87%
|
69
85.2%
|
Male |
9
15.5%
|
3
13%
|
12
14.8%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
8
13.8%
|
3
13%
|
11
13.6%
|
Not Hispanic or Latino |
50
86.2%
|
20
87%
|
70
86.4%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
1
1.7%
|
0
0%
|
1
1.2%
|
Native Hawaiian or Other Pacific Islander |
1
1.7%
|
2
8.7%
|
3
3.7%
|
Black or African American |
15
25.9%
|
8
34.8%
|
23
28.4%
|
White |
32
55.2%
|
13
56.5%
|
45
55.6%
|
More than one race |
1
1.7%
|
0
0%
|
1
1.2%
|
Unknown or Not Reported |
8
13.8%
|
0
0%
|
8
9.9%
|
Region of Enrollment (participants) [Number] | |||
United States |
58
100%
|
23
100%
|
81
100%
|
Outcome Measures
Title | Proportion of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Saxenda | Placebo |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 58 | 23 |
Number [percentage of participants] |
67.24
115.9%
|
4.35
18.9%
|
Adverse Events
Time Frame | 1 year | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Saxenda | Placebo | ||
Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
Saxenda | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/89 (0%) | 0/43 (0%) | ||
Serious Adverse Events |
||||
Saxenda | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/89 (4.5%) | 6/43 (14%) | ||
Gastrointestinal disorders | ||||
ABDOMINAL PAIN | 0/89 (0%) | 1/43 (2.3%) | ||
CONSTIPATION | 0/89 (0%) | 1/43 (2.3%) | ||
INTERNAL HERNIA | 1/89 (1.1%) | 0/43 (0%) | ||
General disorders | ||||
SYNCOPE | 0/89 (0%) | 2/43 (4.7%) | ||
Infections and infestations | ||||
HEPATITIS A | 1/89 (1.1%) | 0/43 (0%) | ||
SEPTIC SHOCK | 1/89 (1.1%) | 0/43 (0%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
PAPILLARY THYROID CANCER | 0/89 (0%) | 1/43 (2.3%) | ||
Surgical and medical procedures | ||||
SURGERY | 1/89 (1.1%) | 1/43 (2.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
Saxenda | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 40/89 (44.9%) | 26/43 (60.5%) | ||
Cardiac disorders | ||||
HIGH BLOOD PRESSURE | 1/89 (1.1%) | 0/43 (0%) | ||
PALPITATIONS | 1/89 (1.1%) | 0/43 (0%) | ||
Ear and labyrinth disorders | ||||
VERTIGO | 1/89 (1.1%) | 0/43 (0%) | ||
Endocrine disorders | ||||
SWOLLEN SALIVARY GLAND | 0/89 (0%) | 1/43 (2.3%) | ||
SWOLLEN THYROID GLAND | 0/89 (0%) | 1/43 (2.3%) | ||
Gastrointestinal disorders | ||||
ABDOMINAL PAIN | 8/89 (9%) | 1/43 (2.3%) | ||
ACID REFLUX | 2/89 (2.2%) | 0/43 (0%) | ||
AGGRAVATED GERD | 1/89 (1.1%) | 0/43 (0%) | ||
CONSTIPATION | 14/89 (15.7%) | 4/43 (9.3%) | ||
DIARRHEA | 4/89 (4.5%) | 3/43 (7%) | ||
FLATULENCE | 0/89 (0%) | 2/43 (4.7%) | ||
GASTRITIS | 0/89 (0%) | 1/43 (2.3%) | ||
NAUSEA | 21/89 (23.6%) | 3/43 (7%) | ||
STOMACH PAIN | 1/89 (1.1%) | 0/43 (0%) | ||
VOMITING | 3/89 (3.4%) | 0/43 (0%) | ||
General disorders | ||||
BAD MOUTH TASTE | 1/89 (1.1%) | 0/43 (0%) | ||
CHEST TIGHTNESS | 1/89 (1.1%) | 0/43 (0%) | ||
DECREASED APPETITE | 4/89 (4.5%) | 0/43 (0%) | ||
DIZZINESS | 1/89 (1.1%) | 0/43 (0%) | ||
DRY MOUTH | 4/89 (4.5%) | 3/43 (7%) | ||
EXCESSIVE PERSPIRATION | 1/89 (1.1%) | 0/43 (0%) | ||
FATIGUE | 6/89 (6.7%) | 1/43 (2.3%) | ||
HAIR LOSS | 0/89 (0%) | 1/43 (2.3%) | ||
HEADACHE | 7/89 (7.9%) | 1/43 (2.3%) | ||
HIGH ENERGY | 1/89 (1.1%) | 2/43 (4.7%) | ||
INCREASED ALCOHOL CONSUMPTION | 0/89 (0%) | 1/43 (2.3%) | ||
INSOMNIA | 3/89 (3.4%) | 2/43 (4.7%) | ||
LACK OF APPETITE | 2/89 (2.2%) | 0/43 (0%) | ||
SENSITIVITY TO COLD (LIGHTHEADNES | 0/89 (0%) | 1/43 (2.3%) | ||
TIGHT CHEST | 1/89 (1.1%) | 0/43 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
GOUT FLARE | 1/89 (1.1%) | 0/43 (0%) | ||
MUSCLE SPASM | 1/89 (1.1%) | 0/43 (0%) | ||
Psychiatric disorders | ||||
ANXIETY | 1/89 (1.1%) | 0/43 (0%) | ||
MOOD CHANGES - INCREASED IRRITABI | 0/89 (0%) | 1/43 (2.3%) | ||
NIGHTTIME BINGE EATING | 0/89 (0%) | 1/43 (2.3%) | ||
Renal and urinary disorders | ||||
ABNORMAL KIDNEY FUNCTION | 1/89 (1.1%) | 0/43 (0%) | ||
INCREASED CREATININE (AGGRAVATED) | 1/89 (1.1%) | 0/43 (0%) | ||
URGENCY TO URINATE | 1/89 (1.1%) | 0/43 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
PNEUMONIA | 1/89 (1.1%) | 0/43 (0%) | ||
SHORTNESS OF BREATH | 1/89 (1.1%) | 0/43 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
BURNING SENSATION AT INJECTION S | 1/89 (1.1%) | 0/43 (0%) | ||
INJECTION SITE SWELLING | 1/89 (1.1%) | 0/43 (0%) | ||
REDNESS AT INJECTION SITE | 0/89 (0%) | 1/43 (2.3%) | ||
Surgical and medical procedures | ||||
ED VISIT | 1/89 (1.1%) | 0/43 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Holly F. Lofton, MD |
---|---|
Organization | NYU Langone Health - Weight Management Program |
Phone | (212) 263-3166 |
Holly.Lofton@nyulangone.org |
- 16-01527