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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)

Must not have

Any change in the dosage of hormonal contraceptive medications (birth control pills, implanon). Subjects should remain on same medication/ same dose during the time of the entire study

Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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

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I am obese with a BMI over 30, or over 27 with related health issues.

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I am obese with a BMI over 30, or over 27 with related health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not changing my hormonal birth control dose during the study.

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My kidney function is significantly impaired.

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My liver is not working well.

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I have gallstones.

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I am currently pregnant, breastfeeding, or planning to become pregnant.

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I drink no more than two drinks a day if I'm a man, or one if I'm a woman.

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I have had weight loss surgery or part of my stomach removed.

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My brain-related medications have not changed recently.

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I do not have any uncontrolled infectious diseases like HIV or hepatitis.

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I do not have any uncontrolled hormone-related conditions.

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I am currently taking warfarin, steroids, or hormone treatments.

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I have major issues with feeling or moving parts of my body.

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I have been diagnosed with cancer or lymphoma.

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I have an eating disorder such as anorexia or bulimia.

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I am taking diabetes medication other than metformin.

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I have a condition like inflammatory bowel disease or rheumatoid arthritis.

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I have been diagnosed with congestive heart failure.

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I have had diabetic ketoacidosis in the past.

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I do not have uncontrolled heart or circulation problems, nor issues with sweating.

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I have untreated thyroid disease.

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I have pancreatitis.

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I have been diagnosed with gastroparesis.

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I or my family have a history of MEN II or medullary thyroid cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BOLD response to food cues

Side effects data

From 2014 Phase 4 trial • 368 Patients • NCT02008682

15%

Nausea

11%

Decreased appetite

Diarrhoea

Lipase increased

Diabetic ketoacidosis

Sudden hearing loss

Bronchitis

100%

80%

60%

40%

20%

Study treatment Arm

Liraglutide

Sitagliptin

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

0 / 25Eligibility criteria met