Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Chicago
Must not be taking: GLP-1 agonists
Disqualifiers: Thyroid cancer, Pancreatitis, Diabetes, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
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.
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.
12345Is 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.
12346How 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.
12345Eligibility Criteria
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.
I am between 18 and 39 years old.
+7 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Study Group 2 (Drug Regimen B)Experimental Treatment2 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 Treatment2 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, United States, European Union, 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
Research Locations NearbySelect from list below to view details:
University of Chicago Medicine Comprehensive Cancer CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Liraglutide for Type 2 diabetes and obesity: a 2015 update. [2015]Subcutaneous liraglutide (Victoza(®), Novo Nordisk) was approved for the treatment of Type 2 diabetes mellitus (T2DM) in Europe in 2009 and in the USA in 2010. In December 2014, liraglutide 3.0 mg was approved by the Food and Drug Administration (FDA) and in March 2015 by the European Medicines Agency (EMA) for the treatment of chronic weight management under the brand name Saxenda(®) Novo Nordisk. Liraglutide causes a glucose-dependent increase in insulin secretion, decreases glucagon secretion and promotes weight loss by inhibiting appetite. Liraglutide probably induces satiety through activation of different areas in the hind brain and possibly by preserving free leptin levels. Recently, liraglutide has been suggested to protect against prediabetes and seems to prevent bone loss by increasing bone formation following diet-induced weight loss in obesity. This article not only covers the major clinical trials evaluating the effects of liraglutide in obesity and T2DM but also provides novel insights into the pharmacological mechanisms of liraglutide.
Liraglutide: an injectable option for the management of obesity. [2022]To review the efficacy and safety of liraglutide, marketed as Saxenda, a glucagon-like peptide-1 analog for obesity management.
[LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. [2016]Liraglutide is an analogue of Glucagon-Like Peptide-1 (GLP-1) already indicated under the trade name of Victoza for the treatment of type 2 diabetes, at usual doses of 1.2 or 1.8 mg as once daily subcutaneous injection. It is henceforth indicated at a dose of 3.0 mg, also as once daily subcutaneous injection, for the treatment of obesity or overweight with comorbidities under the trade name of Saxenda, in combination with diet and exercise. Besides a specific action on the endocrine pancreas, mainly responsible for the antihyperglycaemic effect, liraglutide helps controlling appetite at the hypothamalic level. A specific programme of controlled trials (especially SCALE studies) demonstrated both efficacy and safety of the 3.0 mg dose of liraglutide in obese or overweight patients with various comorbidities.
Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. [2023]To assess the in-market use of Saxenda (liraglutide 3.0 mg) and Victoza (liraglutide 1.2 mg/1.8 mg) according to approved indications and posology.
The Current Role of Liraglutide in the Pharmacotherapy of Obesity. [2019]Liraglutide 3.0 mg daily dose is marketed under the brand name Saxenda and was recently approved by both the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) as adjunct to a comprehensive lifestyle intervention to achieve weight loss.
Clinical pearls for initiating and utilizing liraglutide in patients with type 2 diabetes. [2015]This review presents clinical pearls for initiating liraglutide (Victoza®, Novo Nordisk Inc) therapy for the management of type 2 diabetes and selecting patients who will benefit from liraglutide therapy. Liraglutide, a once-daily glucagon-like peptide 1 receptor agonist, is Food and Drug Administration approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Liraglutide is effective for reducing hemoglobin A1c levels by 0.8% to 1.5% in patients with type 2 diabetes as monotherapy or in combination with other diabetic medications (such as metformin, sulfonylureas, rosiglitazone, or basal insulin) when compared with placebo and these other diabetic medications, including exenatide. Overweight or obese patients with type 2 diabetes or those with insulin resistance are good candidates for liraglutide therapy because liraglutide use is associated with weight loss (about 2%-4% of initial body weight) and improved β-cell function. The incidence of hypoglycemia with liraglutide is low; therefore, liraglutide would be a safe therapy choice for patients at risk or with a history of symptomatic or severe hypoglycemia. Nausea seems to be the most problematic adverse effect associated with liraglutide therapy, but it is usually transient and is minimized with dose titration.