Trial Outcomes & Findings for Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy (NCT NCT03115424)
NCT ID: NCT03115424
Last Updated: 2024-09-27
Results Overview
Subjects calculated weight in kilograms
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
baseline and 36 months
Results posted on
2024-09-27
Participant Flow
Participant milestones
| Measure |
Sleeve Gastrectomy Saxenda
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
25
|
|
Overall Study
COMPLETED
|
12
|
9
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sleeve Gastrectomy Saxenda
n=12 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
n=9 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
n=25 Participants
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 12 • n=12 Participants
|
46 years
STANDARD_DEVIATION 11 • n=9 Participants
|
42 years
STANDARD_DEVIATION 9 • n=25 Participants
|
43 years
STANDARD_DEVIATION 10 • n=46 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=12 Participants
|
8 Participants
n=9 Participants
|
22 Participants
n=25 Participants
|
40 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=12 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=25 Participants
|
6 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
9 participants
n=9 Participants
|
25 participants
n=25 Participants
|
46 participants
n=46 Participants
|
PRIMARY outcome
Timeframe: baseline and 36 monthsPopulation: Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).
Subjects calculated weight in kilograms
Outcome measures
| Measure |
Sleeve Gastrectomy Saxenda
n=12 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
n=9 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
n=25 Participants
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
|---|---|---|---|
|
Weight
baseline
|
127 kilograms
Standard Error 7
|
130 kilograms
Standard Error 8
|
126 kilograms
Standard Error 4
|
|
Weight
36 months
|
75 kilograms
Standard Error 8
|
107 kilograms
Standard Error 10
|
98 kilograms
Standard Error 7
|
SECONDARY outcome
Timeframe: baseline and 36 monthsPopulation: Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).
Systolic blood pressure (top number of blood pressure reading)
Outcome measures
| Measure |
Sleeve Gastrectomy Saxenda
n=12 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
n=9 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
n=25 Participants
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
|---|---|---|---|
|
Systolic Blood Pressure
baseline
|
129 Millimeters of Mercury
Standard Error 4
|
130 Millimeters of Mercury
Standard Error 7
|
123 Millimeters of Mercury
Standard Error 4
|
|
Systolic Blood Pressure
36 months
|
112 Millimeters of Mercury
Standard Error 7
|
128 Millimeters of Mercury
Standard Error 1
|
122 Millimeters of Mercury
Standard Error 7
|
SECONDARY outcome
Timeframe: baseline and 36 monthsPopulation: Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).
Diastolic blood pressure (bottom number of blood pressure reading)
Outcome measures
| Measure |
Sleeve Gastrectomy Saxenda
n=12 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
n=9 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
n=25 Participants
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
|---|---|---|---|
|
Diastolic Blood Pressure
baseline
|
86 Millimeters of Mercury
Standard Error 3
|
83 Millimeters of Mercury
Standard Error 6
|
76 Millimeters of Mercury
Standard Error 2
|
|
Diastolic Blood Pressure
36 months
|
84 Millimeters of Mercury
Standard Error 4
|
93 Millimeters of Mercury
Standard Error 13
|
82 Millimeters of Mercury
Standard Error 3
|
SECONDARY outcome
Timeframe: baseline and 36 monthsPopulation: Data was not collected nor analyzed for eight subjects in the Sleeve Gastrectomy Saxenda arm. Data was not collected nor analyzed for seven subjects in the Sleeve Gastrectomy Placebo arm. Data was not collected nor analyzed for thirteen subjects in the Roux-en-Y Gastric (RYGB).
LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL.
Outcome measures
| Measure |
Sleeve Gastrectomy Saxenda
n=12 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
n=9 Participants
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
n=25 Participants
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
|---|---|---|---|
|
Low-density Lipoprotein (LDL)
baseline
|
114 mg/dL
Standard Error 9
|
101 mg/dL
Standard Error 11
|
99 mg/dL
Standard Error 5
|
|
Low-density Lipoprotein (LDL)
36 months
|
106 mg/dL
Standard Error 20
|
68 mg/dL
Standard Error 1
|
90 mg/dL
Standard Error 7
|
Adverse Events
Sleeve Gastrectomy Saxenda
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Sleeve Gastrectomy Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Roux-en-Y Gastric (RYGB)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sleeve Gastrectomy Saxenda
n=12 participants at risk
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
n=9 participants at risk
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
n=25 participants at risk
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
0.00%
0/9 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
0.00%
0/25 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
Other adverse events
| Measure |
Sleeve Gastrectomy Saxenda
n=12 participants at risk
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Sleeve Gastrectomy Placebo
n=9 participants at risk
Subjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery.
Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
Roux-en-Y Gastric (RYGB)
n=25 participants at risk
Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hgb < 11.5 g/dL
|
0.00%
0/12 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
0.00%
0/9 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
4.0%
1/25 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
|
General disorders
Nausea
|
16.7%
2/12 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
56.0%
14/25 • Number of events 14 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
|
General disorders
Vomiting
|
16.7%
2/12 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
11.1%
1/9 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
52.0%
13/25 • Number of events 13 • Adverse Events were collected from baseline to end of study, approximately 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place