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GLP-1 Receptor Agonist

Saxenda for Obesity

Phase 4
Waitlist Available
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese: BMI> 30 kg/m2 or >27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis)
Obese: BMI> 30 kg/m2 or >27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights

Study Summary

This trial will study the effect of a drug called Liraglutide on areas of the brain that control appetite and food intake.

Who is the study for?
This trial is for adults with obesity (BMI >30 or >27 with related health issues like high blood pressure). It's not for those who are pregnant, breastfeeding, planning to get pregnant, have severe kidney or liver problems, heart failure, certain mental health conditions, uncontrolled infections like HIV/hepatitis, history of pancreatitis or thyroid disease. People with metal implants that affect MRI scans or weigh over 330lbs can't join.Check my eligibility
What is being tested?
The study tests Liraglutide against a placebo to see its effects on brain centers controlling hunger and food intake. Participants will be randomly assigned to receive either the drug or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Liraglutide may cause side effects such as digestive issues (nausea, vomiting), low blood sugar levels especially when combined with other diabetes medications, increased heart rate and potential risk of pancreatitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am obese with a BMI over 30, or over 27 with related health issues.
Select...
I am obese with a BMI over 30, or over 27 with related health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BOLD response to food cues

Side effects data

From 2014 Phase 4 trial • 368 Patients • NCT02008682
15%
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
Group I: Placebo followed by liraglutideExperimental Treatment2 Interventions
Participants will receive placebo with dose titration (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of liraglutide for the same amount of time.
Group II: Liraglutide followed by placeboExperimental Treatment2 Interventions
Participants will receive liraglutide with dose titration over 5 weeks (0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, and 3.0mg for 1 week) followed by a minimum of 3 weeks wash-out and then return for the same dose of placebo for the same amount of time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
liraglutide
2004
Completed Phase 4
~4610

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,011,441 Total Patients Enrolled
21 Trials studying Obesity
752 Patients Enrolled for Obesity

Media Library

Liraglutide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02944500 — Phase 4
Obesity Research Study Groups: Liraglutide followed by placebo, Placebo followed by liraglutide
Obesity Clinical Trial 2023: Liraglutide Highlights & Side Effects. Trial Name: NCT02944500 — Phase 4
Liraglutide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02944500 — Phase 4
Obesity Patient Testimony for trial: Trial Name: NCT02944500 — Phase 4
~1 spots leftby Dec 2024