Trial Outcomes & Findings for Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery (NCT NCT03048578)
NCT ID: NCT03048578
Last Updated: 2022-12-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
132 participants
Primary outcome timeframe
12 Months
Results posted on
2022-12-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
43
|
|
Overall Study
COMPLETED
|
58
|
23
|
|
Overall Study
NOT COMPLETED
|
31
|
20
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
22
|
10
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Terminated
|
3
|
2
|
Baseline Characteristics
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery
Baseline characteristics by cohort
| Measure |
Saxenda
n=58 Participants
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
|
Placebo
n=23 Participants
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
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
23 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsCMH 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
Outcome measures
| Measure |
Saxenda
n=58 Participants
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
|
Placebo
n=23 Participants
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
|
|---|---|---|
|
Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test
|
76 percentage of participants
|
17 percentage of participants
|
Adverse Events
Saxenda
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saxenda
n=89 participants at risk
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
|
Placebo
n=43 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Infections and infestations
HEPATITIS A
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
INTERNAL HERNIA
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Infections and infestations
SEPTIC SHOCK
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Surgical and medical procedures
SURGERY
|
1.1%
1/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
General disorders
SYNCOPE
|
0.00%
0/89 • 1 year
|
4.7%
2/43 • 1 year
|
Other adverse events
| Measure |
Saxenda
n=89 participants at risk
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
|
Placebo
n=43 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.0%
8/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Renal and urinary disorders
ABNORMAL KIDNEY FUNCTION
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
ACID REFLUX
|
2.2%
2/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
AGGRAVATED GERD
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Psychiatric disorders
ANXIETY
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
BAD MOUTH TASTE
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Skin and subcutaneous tissue disorders
BURNING SENSATION AT INJECTION S
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
CHEST TIGHTNESS
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
15.7%
14/89 • 1 year
|
9.3%
4/43 • 1 year
|
|
General disorders
DECREASED APPETITE
|
4.5%
4/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
DIARRHEA
|
4.5%
4/89 • 1 year
|
7.0%
3/43 • 1 year
|
|
General disorders
DIZZINESS
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
DRY MOUTH
|
4.5%
4/89 • 1 year
|
7.0%
3/43 • 1 year
|
|
Surgical and medical procedures
ED VISIT
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
EXCESSIVE PERSPIRATION
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
FATIGUE
|
6.7%
6/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/89 • 1 year
|
4.7%
2/43 • 1 year
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Musculoskeletal and connective tissue disorders
GOUT FLARE
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
HAIR LOSS
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
General disorders
HEADACHE
|
7.9%
7/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Cardiac disorders
HIGH BLOOD PRESSURE
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
HIGH ENERGY
|
1.1%
1/89 • 1 year
|
4.7%
2/43 • 1 year
|
|
General disorders
INCREASED ALCOHOL CONSUMPTION
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Renal and urinary disorders
INCREASED CREATININE (AGGRAVATED)
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Skin and subcutaneous tissue disorders
INJECTION SITE SWELLING
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
INSOMNIA
|
3.4%
3/89 • 1 year
|
4.7%
2/43 • 1 year
|
|
General disorders
LACK OF APPETITE
|
2.2%
2/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Psychiatric disorders
MOOD CHANGES - INCREASED IRRITABI
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASM
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
NAUSEA
|
23.6%
21/89 • 1 year
|
7.0%
3/43 • 1 year
|
|
Psychiatric disorders
NIGHTTIME BINGE EATING
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Cardiac disorders
PALPITATIONS
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Skin and subcutaneous tissue disorders
REDNESS AT INJECTION SITE
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
General disorders
SENSITIVITY TO COLD (LIGHTHEADNES
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
STOMACH PAIN
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Endocrine disorders
SWOLLEN SALIVARY GLAND
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
Endocrine disorders
SWOLLEN THYROID GLAND
|
0.00%
0/89 • 1 year
|
2.3%
1/43 • 1 year
|
|
General disorders
TIGHT CHEST
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Renal and urinary disorders
URGENCY TO URINATE
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Ear and labyrinth disorders
VERTIGO
|
1.1%
1/89 • 1 year
|
0.00%
0/43 • 1 year
|
|
Gastrointestinal disorders
VOMITING
|
3.4%
3/89 • 1 year
|
0.00%
0/43 • 1 year
|
Additional Information
Holly F. Lofton, MD
NYU Langone Health - Weight Management Program
Phone: (212) 263-3166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place