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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the drug Liraglutide (also known as Saxenda, an injection for weight management) affects brain areas that control appetite and food intake, aiming to assist with weight management. Participants will receive either Liraglutide first and then a placebo (a substance with no active drug), or a placebo first followed by Liraglutide, with a break in between. The trial seeks individuals who are obese and may have related conditions like high blood pressure or sleep apnea. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for Liraglutide?

Research shows that liraglutide, the treatment under study, is generally well-tolerated by patients. Studies have found that a 3.0 mg dose of liraglutide, combined with diet and exercise, aids in weight loss and improves overall health. In one study, 85% of adults using liraglutide lost weight over a year.

While liraglutide is mostly safe, some people experience side effects. Common side effects include nausea, diarrhea, or constipation. These effects are usually mild and often resolve over time. The FDA has already approved liraglutide for weight management, indicating it is reasonably safe. However, discussing any concerns with a healthcare provider before joining the trial is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Liraglutide is unique because it targets obesity by mimicking a hormone called GLP-1, which helps regulate appetite and food intake. Unlike other treatments that primarily focus on reducing calorie absorption or burning calories, liraglutide works by directly influencing the brain's hunger signals, potentially leading to more effective weight management. Researchers are excited about liraglutide because it offers a novel approach to controlling obesity, with the potential for significant weight loss and improved health outcomes compared to traditional methods.

What is the effectiveness track record for Liraglutide in treating obesity?

Research has shown that liraglutide, which participants in this trial may receive, helps people with obesity manage their weight. In one study, individuals taking liraglutide lost an average of 5.7% of their body weight, while those on a placebo lost only 1.6%. Another study found that liraglutide, when combined with lifestyle changes, significantly lowered the body mass index (BMI) in teenagers with obesity. These results suggest that liraglutide not only aids in weight loss but also helps maintain it. Liraglutide is already an approved treatment, demonstrating its effectiveness in weight loss. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Placebo followed by liraglutide Experimental Treatment 2 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 placebo Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

Liraglutide, now available at a higher dose of 3.0 mg for treating obesity, has been shown to effectively control appetite and promote weight loss when combined with diet and exercise, based on results from the SCALE studies.

The drug is already established for managing type 2 diabetes at lower doses, and its mechanism of action includes effects on the endocrine pancreas and appetite regulation in the hypothalamus, indicating a dual benefit for patients with obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. Scheen, AJ.[2016]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5358074/

Liraglutide for weight management: a critical review of the ... Liraglutide helps to induce and sustain weight loss in patients with obesity. Its efficacy is comparable to other available agents but it offers the unique ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11508960/

Real-World Clinical Effectiveness of Liraglutide for Weight ... Our study showed that liraglutide is an effective and safe treatment for weight loss in the Turkish population, consistent with the literature.

3. e-jcpp.org e-jcpp.org/journal/view.php?number=61

The effects and side effects of liraglutide as a treatment ... The placebo group showed an average weight loss of 1.6%, while the liraglutide group showed an average weight loss of 5.7%. Subsequently, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823644

One-Year Weight Reduction With Semaglutide or ... Overall, 141 patients (37.4%) receiving semaglutide for obesity achieved 10% or greater body weight reduction vs 223 (16.6%) of those receiving ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1916038

A Randomized, Controlled Trial of Liraglutide for ... In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a significantly greater reduction in the BMI standard-deviation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9325632/

Efficacy and Safety of Liraglutide 3.0 mg in Patients with ... Liraglutide in 3.0 mg subcutaneous dose demonstrated significant weight reduction with a reasonable safety profile for patients with overweight or obesity ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1411892

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in ... In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control.

8. novomedlink.com novomedlink.com/obesity/products/treatments/saxenda/efficacy-safety/significant-weight-loss.html

Saxenda® (liraglutide) Injection 3 mg Clinical Trials for ... In a 1-year study in adults, 85% of patients treated with Saxenda® lost some weight.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000SumR.pdf

206321Orig1s000 - accessdata.fda.gov In trial 1922, 846 patients with T2DM and either obesity or overweight were randomly assigned 2:1:1 to daily doses of liraglutide 1.8 mg, 3 mg, or placebo for ...

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK594336/

Clinical Review - Liraglutide (Saxenda) - NCBI Bookshelf - NIH The NMA also found that treatment with liraglutide 3 mg increases the odds of a patient losing at least 5% of body weight compared with orlistat (OR = 2.06; 95% ...