Examining the Utility of GLP-1 Agonists as Neuroprotective Agents Through a Pilot Clinical Trial in High Risk Population With Neurocognitive Deficits and Obesity

Plain English Summary

Study of Liraglutide (A Weight Loss Drug) in High Risk Obese Participants With Cognitive and Memory Issues is a Phase 1 clinical trial sponsored by University of Chicago studying Multiple Sclerosis, Long COVID, Long Covid19, Obese, Obesity, Obesity, Morbid, Acute Leukemia in Remission. This trial tests if liraglutide, a weight loss drug, can help improve thinking and memory problems. It is for obese adults (BMI over 27) with conditions like Multiple Sclerosis, Long COVID, or leukemia in remission who also experience cognitive difficulties. Participants will receive liraglutide injections and track their medication for about 21 weeks. Currently, there are no approved treatments specifically for these cognitive issues in this patient group. The trial aims to enroll 30 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have Multiple Sclerosis, Long COVID, or leukemia in remission, and a BMI of 27 or higher with a weight-related condition (or BMI 30+). You must be between 18 and 39 years old and have noticed problems with memory, concentration, or decision-making. You cannot join if you have a history of pancreatitis, certain thyroid conditions, or have used GLP-1 drugs before. Women who can get pregnant must agree to use contraception during the study. This trial is studying Multiple Sclerosis, Long COVID, Long Covid19, Obese, Obesity, Obesity, Morbid, Acute Leukemia in Remission, so participants generally need a confirmed diagnosis.

What They're Measuring

The study will measure changes in a protein called BDNF in the blood, which is thought to be important for brain health, to see if the drug has a positive effect on brain function. The specific primary outcome measures are: Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks (8 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial explores if a common weight loss drug can protect the brain and improve cognitive function in individuals with specific chronic conditions and obesity, addressing a gap in treatments for th This research targets Multiple Sclerosis, Long COVID, Long Covid19, Obese, Obesity, Obesity, Morbid, Acute Leukemia in Remission, where improved treatment options are needed.

Investor Insight

This early-phase study, while not a direct investment signal, explores a novel use for an existing drug (liraglutide) in a potentially large patient population experiencing cognitive decline, suggesti Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if liraglutide is appropriate for you and what the potential benefits and risks are. Understand that you will need to inject yourself with the medication and keep a diary of your doses. Be prepared for regular clinic visits to monitor your progress and for blood tests. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 30 participants

Interventions

• DRUG: Liraglutide Pen Injector [Saxenda] — A weight loss drug that can be taken at home. Liraglutide will be provided as an injectable pen that participants can inject in the stomach, thigh or upper arm. A member of the research team will give you instructions on how to inject liraglutide using the injectable pen and answer any questions.
• OTHER: Medication Diary — Participants will be asked to maintain a medication diary of each dose of liraglutide. A member of the research team will provide a copy of this diary for participants to complete. Participants will be asked to return this medication diary to research staff at each clinic visit.

Primary Outcomes

• Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks (8 weeks)

Secondary Outcomes

• Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 4 Weeks (4 weeks)
• Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 12 Weeks (12 weeks)
• Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 21 Weeks (21 weeks)

Full Eligibility Criteria

Inclusion Criteria:

1. Patients with MS, acute leukemia in remission, or long-COVID and subjective symptoms of cognitive impairment a. Patients with acute leukemia must be in remission for at least 6 months but may be on maintenance therapy

   * Must have BMI greater than or equal to 27 along with one weight related condition such as hypertension, insulin resistance, or dyslipidemia or with BMI greater than or equal to 30 alone
   * Ages ≥18 but \<40 years old
   * Adequate organ function as defined by the following:

     1. Creatinine ≤1.5 mg/dL
     2. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤5 x upper limit normal (ULN) and bilirubin ≤1.5 mg/dL
   * Participants must be at least 2 months from major surgery, radiation therapy, or participation in other investigational trials, and must have recovered from clinically significant toxicities related to these prior treatments.
   * Female participants of childbearing potential must have negative results for a pregnancy test at baseline testing time point
   * Must be willing to use appropriate contraception
   * The effects of liraglutide on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 8 weeks after completion of liraglutide administration.
   * Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of multiple endocrine neoplasia type 2 (MEN2)
* Personal or family history of thyroid cancer
* Previous or current diagnosis of acute and/or chronic pancreatitis
* Any prior GLP-1 agonist therapy
* Poorly controlled diabetes mellitus with an indication for liraglutide (Victoza) for its management
* Previous or current diagnosis of fibromyalgia
* Participants who are receiving any other investigational agents.
* Participants with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to liraglutide.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because liraglutide is a Category X agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with liraglutide, breastfeeding should be discontinued prior to enrollment in the trial.
* Participants with congenital cognitive dysfunction or severe cognitive dysfunction unrelated to diagnosis of leukemia, Multiple Sclerosis, or COVID.

Trial Locations

• University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

Frequently Asked Questions

Related Conditions

• Multiple Sclerosis
• Long COVID
• Obesity
• Acute Leukemia
• Cognitive Impairment
• Neuroprotection
• Metabolic Syndrome
• Hypertension
• Insulin Resistance
• Dyslipidemia

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