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SuspendedPhase EARLY_1

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

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

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

30

estimated

Study population

Alzheimer's / cognition, COVID / long COVID, Multiple sclerosis, Obesity / overweight, Oncology

Key I/E criterion

BMI ≥27

Primary endpoint

Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06171152
Org study IDIRB23-0848

Timeline

Milestones

Study first posted2023-12-14actual
Study start2024-01-26actual
Last update posted2026-03-30actual
Primary completion2027-06-01estimated
Study completion2027-10-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Alzheimer's / cognitionCOVID / long COVIDMultiple sclerosisObesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

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

Time frame:8 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:4 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:12 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:21 weeks

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.