A double-blinded, randomised, placebo-controlled trial of semaglutide 3.0 mg/ml in patients with poor weight-loss following bariatric surgery. The primary aim of this trial is to determine whether, and the extent to which, 68 weeks of subcutaneous semaglutide 3.0 mg/ml causes greater percentage weight loss (%WL), reduction in adiposity, improvement in metabolic and inflammatory indices and health-related quality of life (HRQoL) than placebo, in patients with poor weight loss following gastric bypass or sleeve gastrectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Semaglutide 2.4 mg/week, subcutaneous injection. Treatment dose: 16 weeks of dose escalation + 52 weeks of study dose (i.e., 2.4 mg/week).
Placebo
Janine Makaronids
London, United Kingdom
Weight loss
Percentage of total weight loss
Time frame: 68 weeks
body weight reduction ≥10%
To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥10%
Time frame: 68 weeks
body weight reduction ≥15%
To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥15%
Time frame: 68 weeks
body weight reduction ≥20%
To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥20%
Time frame: 68 weeks
Change in circulating HbA1c levels
The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c
Time frame: 68 weeks
Change in circulating HbA1c levels in participants with pre-diabetes at baseline
The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c in participants with pre-diabetes at baseline
Time frame: 68 weeks
Change in circulating HbA1c levels in participants with T2D at baseline
The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c in participants with diabetes at baseline
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Time frame: 68 weeks
Systolic and diastolic BP
The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon BP
Time frame: 68 weeks
Systolic and diastolic BP in participants with pre-existing hypertension
The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon BP in participants with pre-existing hypertension
Time frame: 68 weeks
pharmacological agents required for the management of hypertension
The number of pharmacological agents required for the management of hypertension in participants with pre-existing hypertension
Time frame: 68 weeks
Change in circulating lipids
To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon circulating lipids
Time frame: 68 weeks
Change in circulating HsCRP and inflammatory cytokines
To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon inflammatory markers
Time frame: 68 weeks
Changes in food craving scores assessed through power of food questionnaire
To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon food cravings
Time frame: 68 weeks
Changes in HRQoL
To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HRQoL
Time frame: 68 weeks
GLP-1 levels
To investigate the relationship between fasted and meal-stimulated active GLP-1 levels at baseline and %WL at 68 weeks
Time frame: 68 weeks