GLP-1 Receptor Agonist
Saxenda® for Obesity
Nutrition & Metabolic Health Initiative, Lubbock, TX
Saxenda® +1 moreN/AWaitlist AvailableLed by Nikhil V Dhurandhar, PhDResearch Sponsored by Texas Tech UniversityEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI 30-50 kg/m2
BMI 30-50 kg/m2
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline, week 4, and week 16
Awards & highlights
All Individual Drugs Already Approved
Study Summary
This trialwill measure the effectiveness of Saxenda® on weight loss, hunger, cravings and brain imaging, with subjects randomly assigned to the Saxenda® or placebo group.
Eligible Conditions
- Obesity
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a body mass index (BMI) between 30 and 50.
Select...
Your body mass index (BMI) is between 30 and 50.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, and week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, and week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare the changes of energy intake in Liraglutide 3.0 vs. Placebo Group
Compare the changes of hunger/satiety in Liraglutide 3.0 vs. Placebo Group
Compare the changes of post-prandial fMRI-FCR in Liraglutide 3.0 vs. Placebo Group
+3 moreSecondary outcome measures
Correlation between changes in post-prandial fMRI-FCR and changes in energy intake
Correlation between changes in post-prandial fMRI-FCR and changes in hunger/satiety
Examine if the correlations described in outcome 10 differ in Liraglutide 3.0 vs. Placebo Group
+6 moreSide effects data
From 2014 Phase 4 trial • 368 Patients • NCT0200868215%
Nausea
11%
Decreased appetite
8%
Diarrhoea
6%
Lipase increased
1%
Sudden hearing loss
1%
Bronchitis
1%
Diabetic ketoacidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Liraglutide
Sitagliptin
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liraglutide 3.0Experimental Treatment1 Intervention
Subjects in Liraglutide 3.0 group will receive Saxenda® plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will be asked to maintain physical activity. The dose of Saxenda® will be increased weekly in the first 4 weeks (.6; 1.2; 1.8; 2.4 mg) and maintained on 3 mg for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Subjects in placebo group will receive placebo plus behavioral weight loss counselling to portion control to achieve 500 kcal daily deficit based on MedGem required maintenance calories (not to be reduced below 1000 kcal per day for any subject). Subjects will also be asked to maintain physical activity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide
FDA approved
Find a site
Who is running the clinical trial?
Texas Tech UniversityLead Sponsor
71 Previous Clinical Trials
8,496 Total Patients Enrolled
10 Trials studying Obesity
453 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,458 Previous Clinical Trials
2,326,874 Total Patients Enrolled
128 Trials studying Obesity
127,429 Patients Enrolled for Obesity
Nikhil V Dhurandhar, PhDPrincipal Investigator
Texas Tech UniversityMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study allow for octogenarians to participate?
"This trial only enrolls patients aged 18 to 60. For patients below 18 years old, there are 214 other clinical trials and for patients above 65, there are 732 trials."
Answered by AI
What indications does Saxenda® typically address?
"While frequently used as a treatment for exercise, Saxenda® can also help patients that have poor control on monotherapy, are at risk for cardiovascular disease, and have cardiovascular disease."
Answered by AI
How many people aremaximally recruited for this research project?
"Presently, this particular trial is not looking for new patients to enroll. The trial was originally posted on 8th January 2019 and was last updated on 1st November 2022. However, there are other weight loss trials with 1099 studies currently admitting patients and 36 trials for Saxenda® that are actively enrolling patients."
Answered by AI
Are there any specific requirements for volunteers in this clinical trial?
"Eligibility requirements for this trial are as follows: age 18-60 years, BMI 30-50 kg/m2, and current weight loss. So far, 73 patients have been enrolled."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Florida
Arizona
Other
How old are they?
18 - 65
What site did they apply to?
Nutrition & Metabolic Health Initiative
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- Nutrition & Metabolic Health Initiative: < 24 hours