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Anti-obesity Agent
Liraglutide for Obesity
Phase < 1
Recruiting
Led By Adam DuVall, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages ≥18 but <40 years old
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial is for people with multiple sclerosis, acute leukemia (in remission), or long-COVID who have a Body Mass Index over 27 and experience cognitive issues. The researchers want to see
Who is the study for?
This trial is for adults aged 18-40 with obesity and cognitive issues who also have multiple sclerosis, are in remission from acute leukemia, or suffer from long-COVID. They must have a BMI over 27 with related health conditions or a BMI over 30 alone. Participants need functioning liver and kidneys, not be pregnant, use contraception, and be past certain treatments.
What is being tested?
Researchers are testing the weight loss drug Liraglutide (Saxenda®) using a pen injector to see if it changes levels of BDNF—a marker that could affect memory and thinking. The study lasts about 21 weeks and includes keeping a medication diary.
What are the potential side effects?
Possible side effects of Liraglutide may include nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), reduced appetite, headache, fatigue; rare but serious side effects can occur like pancreatitis or gallbladder problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 39 years old.
Select...
My BMI is 27 or higher with a weight-related condition, or it's 30 or higher alone.
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My liver tests are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks
Secondary study objectives
Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 12 Weeks
Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 21 Weeks
Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 4 Weeks
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Study Group 2 (Drug Regimen B)Experimental Treatment2 Interventions
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
Group II: Study Group 1 (Drug Regimen A)Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide Pen Injector [Saxenda]
2018
Completed Phase 4
~160
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
840,106 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
221 Patients Enrolled for Multiple Sclerosis
Adam DuVall, MDPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center