Your session is about to expire
← Back to Search
GLP-1 Receptor Agonist
Saxenda® for Weight Loss in Obesity
N/A
Waitlist Available
Led By Nikhil V Dhurandhar, PhD
Research Sponsored by Texas Tech University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, and week 16
Awards & highlights
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
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
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
Saxenda®
2021
Completed Phase 1
~440
Find a Location
Who is running the clinical trial?
Texas Tech UniversityLead Sponsor
81 Previous Clinical Trials
9,091 Total Patients Enrolled
10 Trials studying Obesity
453 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,513 Previous Clinical Trials
2,414,956 Total Patients Enrolled
141 Trials studying Obesity
131,965 Patients Enrolled for Obesity
Nikhil V Dhurandhar, PhDPrincipal InvestigatorTexas Tech University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been consistently not feeling hungry, feeling sick to your stomach, or throwing up for the past 4 weeks without a known reason like the flu or food poisoning.You have severe mental illnesses like psychosis, schizophrenia, bipolar disorders, or severe depression.You have been diagnosed with serious eating disorders like anorexia nervosa, bulimia nervosa, or severe binge eating disorder in the past.You have a history of using drugs or drinking alcohol excessively.You have smoked within the past month.You have difficulties with moving, seeing, or hearing.Your body mass index (BMI) is between 30 and 50.You are currently thinking about hurting yourself or have tried to hurt yourself in the past.You have been diagnosed with diabetes (either type 1 or type 2) or high blood pressure that is not well controlled. You also have a history of heart disease, stroke, or neurological problems.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Liraglutide 3.0
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger