← Back to Search

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 below

Select...

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.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 weeks for reporting.

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

0 / 3Eligibility criteria met