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Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

28 Participants Needed

Saxenda for Obesity

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Warfarin, Steroids, Hormones, others

Disqualifiers: Pregnancy, Renal impairment, Hepatic impairment, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stay on the same medication and dose throughout the study. If you are taking medications like warfarin, steroids, or certain hormones, you may not be eligible to participate.

What data supports the effectiveness of the drug Saxenda for obesity?

Research shows that Saxenda, which contains liraglutide, helps people lose weight by reducing appetite. In clinical trials, people using Saxenda lost more weight compared to those taking a placebo, especially when combined with diet and exercise.¹ ² ³ ⁴ ⁵

Is Saxenda (liraglutide) safe for humans?

Saxenda (liraglutide) has been shown to be generally safe in humans for managing obesity, with clinical trials demonstrating its safety and effectiveness when used alongside diet and exercise. It is well tolerated and has been approved for use in both the USA and Europe for weight management.¹ ² ³ ⁴ ⁵

What makes the drug Saxenda unique for treating obesity?

Saxenda, a form of liraglutide, is unique because it is a once-daily injection that not only helps control blood sugar levels but also reduces appetite by acting on the brain, making it effective for weight loss when combined with diet and exercise.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

The purpose of this protocol is to investigate the effect of treatment with the study drug Liraglutide, a GLP-1 receptor agonist, on centers of the brain that control appetite and food intake.

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

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

My kidney function is significantly impaired.

I have gallstones.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive liraglutide with dose titration over 5 weeks followed by a minimum of 3 weeks wash-out, then placebo for the same duration, or vice versa.

16 weeks

Weekly visits for dose titration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Liraglutide
Placebo

Trial Overview 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.

Participant Groups

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.

Liraglutide is already approved in United States, European Union for the following indications:

Approved in United States as Victoza for:

Type 2 diabetes mellitus treatment
Cardiovascular risk reduction in adults with type 2 diabetes and heart disease

Approved in United States as Saxenda for:

Weight loss treatment in adults and children aged 12 and older with obesity

Approved in European Union as Victoza for:

Type 2 diabetes mellitus treatment
Cardiovascular risk reduction in adults with type 2 diabetes and heart disease

Approved in European Union as Saxenda for:

Weight loss treatment in adults and children aged 12 and older with obesity

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Findings from Research

Liraglutide (Saxenda) has been shown to effectively promote weight loss in overweight and obese patients, with a higher percentage achieving 5% and 10% weight loss compared to placebo and orlistat, based on randomized controlled studies.

The medication is generally safe, with gastrointestinal side effects being the most common and typically dose-dependent, making it a viable adjunct to lifestyle changes for obesity management, especially in patients with prediabetes and women with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide: an injectable option for the management of obesity.Clements, JN., Shealy, KM.[2022]

Liraglutide, approved for Type 2 diabetes and chronic weight management, works by increasing insulin secretion and decreasing appetite, which helps promote weight loss.

Recent findings suggest that liraglutide may also protect against prediabetes and prevent bone loss by enhancing bone formation after weight loss, highlighting its broader health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide for Type 2 diabetes and obesity: a 2015 update.Iepsen, EW., Torekov, SS., Holst, JJ.[2015]

In a study of 225 patients prescribed Saxenda and Victoza, 96% and 98.7% of prescriptions, respectively, were in line with approved indications, indicating high adherence to guidelines.

Only 5% of patients using Saxenda for 16 weeks or longer were non-adherent to the stopping rule, suggesting that these medications are being used safely and effectively in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study.Sbraccia, P., Aberle, J., Olsen, AH., et al.[2023]