AzTrials
AzTrials

Multiple SclerosisEarly Phase 1NCT06171152

Study of Liraglutide (A Weight Loss Drug) in High Risk Obese Participants With Cognitive and Memory Issues

A Early Phase 1 study testing Liraglutide Pen Injector [Saxenda] and Medication Diary in people with Multiple Sclerosis and Long COVID, run by University of Chicago at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Multiple Sclerosis, Long COVID, Long Covid19
What is being tested?
Liraglutide Pen Injector [Saxenda] and Medication Diary
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
26 Jan 2024to 1 Oct 2027
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
  • Creatinine ≤1.5 mg/dL
  • Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤5 x upper limit normal (ULN) and bilirubin ≤1.5 mg/dL
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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 and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

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

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.

Read the detailed description

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).

Previous research has shown that liraglutide may help regulate BDNF levels, which can be linked to issues with cognitive and mental performance. Participation in this research will last about 21 weeks.

Being tested
Liraglutide Pen Injector [Saxenda], Medication Diary
Medical subject headings
Multiple Sclerosis, Post-Acute COVID-19 Syndrome, Obesity, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liraglutide Pen Injector [Saxenda]Drug

    Also called Saxenda, Victoza

    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.

  • Medication DiaryOther

    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.

Study groups in NCT06171152
Study groupRoleWhat they receive
Study Group 1 (Drug Regimen A)ExperimentalDuring 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
Receives: Drug: Liraglutide Pen Injector [Saxenda]; Other: Medication Diary
Study Group 2 (Drug Regimen B)ExperimentalDuring 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
Receives: Drug: Liraglutide Pen Injector [Saxenda]; Other: Medication Diary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks

    Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels after reaching the goal dose of GLP-1 agonist (8 weeks).

    Measured: 8 weeks

Secondary outcomes (3)

  1. Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 4 Weeks

    Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at 4 weeks.

    Measured: 4 weeks

  2. Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 12 Weeks

    Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at 12 weeks.

    Measured: 12 weeks

  3. Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 21 Weeks

    Change from baseline in serum Brain Derived Neurotrophic Factor (BDNF) levels at discontinuation of study drug (21 weeks).

    Measured: 21 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start26 Jan 2024
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Why it stopped: Study pending amendment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171152
Sponsor's protocol ID
IRB23-0848
Status last verified
Mar 2026
First submitted
6 Dec 2023
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Liraglutide Pen Injector [Saxenda] and Medication Diary in people with Multiple Sclerosis and Long COVID, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06171152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in