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 trial tests how the weight loss drug liraglutide (known as Victoza or Saxenda) affects a disease marker in individuals with a BMI over 27 who also have multiple sclerosis, acute leukemia (in remission), or long-COVID, along with cognitive issues such as trouble concentrating or remembering. Researchers aim to determine if liraglutide can impact levels of Brain Derived Neurotrophic Factor (BDNF), a body marker. The trial involves different dosing schedules randomly assigned to participants and may suit those with these conditions who also face weight-related issues like high blood pressure or insulin resistance. Participation lasts about 21 weeks. As an Early Phase 1 trial, this research focuses on understanding how liraglutide works in people, offering participants a chance to contribute to groundbreaking insights.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that liraglutide, a medication often used for weight loss, has been generally safe in past studies. For example, one study using a 3.0 mg dose of liraglutide found it safe and effective for helping people with obesity lose weight. Most participants handled the medication well, with only mild side effects like nausea or diarrhea. Another study found similar results, indicating that liraglutide helped reduce body weight and improve health without serious safety issues. While these studies focused on weight loss, they provide useful information about the drug's overall safety. As this trial is in an early stage, researchers are closely monitoring the treatment's safety while collecting more data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Liraglutide stands out because it mimics a hormone called GLP-1, which helps regulate appetite and food intake. Unlike many traditional obesity treatments that might focus on calorie restriction or increased physical activity, liraglutide directly targets the brain's hunger signals to help reduce appetite. Researchers are excited about this drug because it's already shown promise in improving weight loss outcomes with a relatively straightforward daily injection schedule, potentially offering a more effective option for people struggling with obesity.

What evidence suggests that liraglutide might be an effective treatment for obesity in people with multiple sclerosis, acute leukemia (in remission), or long-COVID?

Research has shown that liraglutide, a weight loss drug, helps people lose weight effectively. In one study, taking 3.0 mg of liraglutide, along with diet and exercise, led to weight loss and improved metabolism. Participants using liraglutide lost more total body weight and fat compared to those who did not take it. Another study found that people lost about 8% of their body weight after 56 weeks on 3.0 mg of liraglutide. In this trial, participants will follow different dosing regimens of liraglutide to evaluate its effectiveness in weight management. These findings suggest liraglutide can be a powerful tool for managing weight. ^{2 6 7 8 9}

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 (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]

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]

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 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]

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]

Citations

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

Liraglutide for Weight Management: Critical Review Comparative data suggest that weight loss with liraglutide is greater than that seen with orlistat or lorcaserin, but slightly less that seen with phentermine/ ...

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

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

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

Randomized Trial: 3.0 mg Liraglutide for Weight Management 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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1871403X25000158

Effects of liraglutide on body composition in people living ... Liraglutide consistently demonstrated significant reductions in total weight, fat mass, and visceral adipose tissue (VAT) compared to placebo across the ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15845

Real-life use of liraglutide 3 mg for obesity: SAX-RL study The SCALE Obesity and Prediabetes trial in the same year demonstrated a mean weight loss of 8% at 56 weeks with liraglutide 3 mg, showing a 5.4% ...

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. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000299

Weight loss outcomes, tolerability, side effects, and risks GLP-1RAs demonstrated significant weight loss outcomes. In clinical trials, liraglutide showed a placebo-corrected weight loss of around 5 %, semaglutide 12 %, ...

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2807724

Safety and Efficacy of Liraglutide, 3.0 mg, Once Daily vs ... The results of this study demonstrate that liraglutide, 3.0 mg, was safe and effective as a weight management intervention in this patient population.

9. 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.