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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
Summary
This trial tests Saxenda®, an injectable medication that helps with weight loss by reducing hunger and increasing feelings of fullness. The study targets individuals in a weight loss program to see how the medication affects their brain's response to food and their overall weight loss.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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%
Diabetic ketoacidosis
1%
Sudden hearing loss
1%
Bronchitis
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
82 Previous Clinical Trials
9,206 Total Patients Enrolled
10 Trials studying Obesity
453 Patients Enrolled for Obesity
Novo Nordisk A/SIndustry Sponsor
1,552 Previous Clinical Trials
2,444,987 Total Patients Enrolled
153 Trials studying Obesity
143,718 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.
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