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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06171152
Phase
EARLY_PHASE1
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide Pen Injector [Saxenda] — DRUG
    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 Diary — OTHER
    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 Details

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.

Key Dates

Start date
Jan 26, 2024
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
COVID-19 / long COVIDMultiple sclerosisObesity / overweight
By specialty
Infectious diseaseNeurologyBrain disordersAutoimmune diseaseEndocrinologyMetabolic healthWeight loss
By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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