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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

⁃ 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.

Locations
United States
Illinois
University of Chicago Medicine Comprehensive Cancer Center
RECRUITING
Chicago
Contact Information
Primary
Cancer Trials Intake
cancerclinicaltrials@bsd.uchicago.edu
1-855-702-8222
Time Frame
Start Date: 2024-01-26
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 30
Treatments
Experimental: Study Group 1 (Drug Regimen A)
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
Experimental: Study Group 2 (Drug Regimen B)
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
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov

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