Saxenda®
DrugReceiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks.
Other names: Liraglutide 3.0
NCT Number: NCT03795701
The study is a single center, randomized, double blind, placebo controlled; parallel-group repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo group after baseline assessments. The study will consist of a 4-week partial dose period (Liraglutide 0.6mg, 1.2mg, 1.8mg, 2.4 mg) and a 12-week full-dose (Liraglutide 3.0 mg) period. The placebo group will administer equivalent volumes of the pre-filled solutions from pen-injector at the same time, using the same method during this period. The study proposes to identify factors contributing to early weight loss response in a Saxenda® treatment program. Specifically, the proposed experiments will help determine if Saxenda® changes brain functional Magnetic Resonance Imaging Food Cue Reactivity (fMRI-FCR) and whether the magnitude of that change is associated with changes in behavioral and physiological variables (hunger, satiety, cravings and weight loss).
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Nutrition & Metabolic Health Initiative, Lubbock, Texas, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks.
Other names: Liraglutide 3.0
Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group .
Time frame: Baseline, Week 4, and Week 16
Pre-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Energy intake will be assessed via ad libitum feeding
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation is paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated').
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via glucagon-like peptide-1 (GLP-1)
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via Peptide YY (PYY)
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be assessed via ghrelin
Time frame: Baseline, Week 4, and Week 16
Pre-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR will be measured via fMRI
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR measured via fMRI. Energy intake will be assessed via ad libitum feeding.
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry').
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1).
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via peptide YY (PYY).
Time frame: Baseline, Week 4, and Week 16
Post-prandial fMRI-FCR measured via fMRI. Hunger/satiety will be measured via ghrelin.
Time frame: Baseline, Week 4, and Week 16
Energy intake will be assessed via ad libitum feeding.
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry').
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1)
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via peptide YY (PYY)
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via ghrelin
Time frame: Baseline, Week 4, and Week 16
Energy intake will be assessed via ad libitum feeding
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via Visual Analog Scale (VAS). Subjects will rate on the 100 mm line with a vertical line. There is no specific number on the scale. On each 100-mm line, an sensation was paired with the opposing sensation, (for example, 'not at all hungry' and 'extremely hungry' or 'Not at all satiated' and 'extremely satiated').
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via glucagon-like peptide-1 (GLP-1)
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via peptide YY (PYY)
Time frame: Baseline, Week 4, and Week 16
Hunger/satiety will be measured via ghrelin
Texas Tech University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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