Liraglutide for Obesity

Overseen By Adam Duvall, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Chicago

Must not be taking: GLP-1 agonists

Disqualifiers: Thyroid cancer, Pancreatitis, Diabetes, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is for people who have multiple sclerosis, acute leukemia (in remission), or long-COVID and a Body Mass Index over 27 and may struggle with cognitive issues such as remembering information, concentrating, or making decisions that affect everyday life. By doing this study, researchers hope to learn how liraglutide (Saxenda®), a weight loss drug, affects levels of a certain disease marker in the body called Brain Derived Neurotrophic Factor (BDNF). Participation in this research will last about 21 weeks.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on any investigational agents, you cannot participate in this trial.

Is liraglutide safe for humans?

Liraglutide, used under the names Victoza and Saxenda, has been approved for treating type 2 diabetes and obesity. It is generally considered safe, with nausea being the most common side effect, which usually goes away over time. The risk of low blood sugar (hypoglycemia) is low, making it a safe option for many people. ^{1 2 3 4 5}

How is the drug Liraglutide unique for treating obesity?

Liraglutide, marketed as Saxenda, is unique for treating obesity 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 6}

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

Liraglutide, marketed as Saxenda, has been shown to help with weight loss by reducing appetite and increasing feelings of fullness. Clinical trials, such as the SCALE studies, have demonstrated its effectiveness and safety for managing obesity when combined with diet and exercise. ^{1 2 3 4 6}

Who Is on the Research Team?

Adam DuVall

Principal Investigator

University of Chicago Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 with obesity and cognitive issues who also have multiple sclerosis, are in remission from acute leukemia, or suffer from long-COVID. They must have a BMI over 27 with related health conditions or a BMI over 30 alone. Participants need functioning liver and kidneys, not be pregnant, use contraception, and be past certain treatments.

Inclusion Criteria

I have MS, leukemia in remission for 6+ months, or long-COVID with thinking problems.

Women who can have children must use birth control during the study. If a woman becomes pregnant during the study, she must tell her doctor right away. Men in the study must also use birth control during and after the study.

You understand what the study involves and agree to sign a paper saying you want to take part.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive liraglutide in cycles with varying doses over 21 weeks

21 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liraglutide

Trial Overview Researchers are testing the weight loss drug Liraglutide (Saxenda®) using a pen injector to see if it changes levels of BDNF—a marker that could affect memory and thinking. The study lasts about 21 weeks and includes keeping a medication diary.

How Is the Trial Designed?

Group I: Study Group 2 (Drug Regimen B) Experimental Treatment 2 Interventions

During the study, liraglutide will be given in "cycles." A cycle is a scheduled period of time for taking study drugs. For this study, each cycle length as well as the dose of liraglutide participants take will be based on the drug regimen (or schedule) they receive. The drug regimen receive each participant receives will be selected using a random assignment process, similar to flipping a coin. Participants in this study group will receive Drug Regimen B, which means they will take liraglutide at the below doses and times: Dose Schedule Cycle Length 0.6mg Daily 5 weeks 1.2mg Daily 1 week 1.8mg Daily 1 week 2.4mg Daily 1 week 3.0mg Daily 4 weeks

Group II: Study Group 1 (Drug Regimen A) Experimental Treatment 2 Interventions

During the study, liraglutide will be given in "cycles." A cycle is a scheduled period of time for taking study drugs. For this study, each cycle length as well as the dose of liraglutide participants take will be based on the drug regimen (or schedule) they receive. The drug regimen receive each participant receives will be selected using a random assignment process, similar to flipping a coin. Participants in this study group will receive Drug Regimen A, which means they will take liraglutide at the below doses and times: Dose Schedule Cycle Length 0.6mg Daily 1 week 1.2mg Daily 1 week 1.8mg Daily 1 week 2.4mg Daily 1 week 3.0mg Daily 8 weeks

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?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

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]

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, 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]

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]

In a 56-week study, liraglutide 3.0 mg daily resulted in a significant weight reduction of 5.9-8.0%, with 50-76% of patients achieving at least a 5% weight loss, indicating its efficacy as a weight loss treatment.

Liraglutide also improved several health markers, including waist circumference, triglycerides, insulin resistance, and blood pressure, while being generally well tolerated, although some common side effects included nausea and diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current Role of Liraglutide in the Pharmacotherapy of Obesity. Christou, GA., Katsiki, N., Kiortsis, DN.[2019]

Liraglutide is an effective treatment for type 2 diabetes, reducing hemoglobin A1c levels by 0.8% to 1.5%, and is safe for patients at risk of hypoglycemia due to its low incidence of this side effect.

It is particularly beneficial for overweight or obese patients, as it not only helps control blood sugar but also promotes weight loss of about 2%-4% of initial body weight, although nausea can occur but is typically manageable with careful dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pearls for initiating and utilizing liraglutide in patients with type 2 diabetes. Gross, B.[2015]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Liraglutide for Type 2 diabetes and obesity: a 2015 update. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Liraglutide: an injectable option for the management of obesity. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2023]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The Current Role of Liraglutide in the Pharmacotherapy of Obesity. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical pearls for initiating and utilizing liraglutide in patients with type 2 diabetes. [2015]