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NCT06171152·Early Phase 1·INTERVENTIONAL

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

Status

Suspended

Phase

Early Phase 1

Enrollment

30

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Dec 14, 2023

  2. Study start

    Jan 26, 2024

  3. Primary completion

    Jun 1, 2027

  4. Study completion

    Oct 1, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Mar 30, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 8 weeks

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

Secondary outcomes

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

Time frame · 4 weeks

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

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

Time frame · 12 weeks

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

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

Time frame · 21 weeks

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.