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

Plain-language guide to NCT06171152: early phase 1 randomized trial of Liraglutide, fat loss, obesity & body recomposition, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06171152
Phase
early phase 1
Status
suspended
Start
2024-01-26
Completion (planned or actual)
2027-06-01
Participants
30 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Multiple Sclerosis; Long COVID; Long Covid19; Obese; Obesity; Obesity, Morbid
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered early phase 1 trial tested Liraglutide for fat loss, obesity & body recomposition and multiple sclerosis.

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.

It had two arms (groups): Study Group 1 (Drug Regimen A) (experimental) and Study Group 2 (Drug Regimen B) (experimental).

The registry classes the interventions as drug and other.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ages ≥18 but \<40 years old. Adequate organ function as defined by the following:. 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. Ability to understand and the willingness to sign a written informed consent document.

The full record lists 11 inclusion and 13 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Liraglutide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

It started in 2024-01-26 with completion listed for 2027-06-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 8 Weeks (time frame: 8 weeks).

It also tracked 3 secondary outcomes, for example Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 4 Weeks, Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 12 Weeks and Change from Baseline in Serum Brain Derived Neurotrophic Factor (BDNF) after 21 Weeks.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Liraglutide in 30 people with fat loss, obesity & body recomposition.

Its size is small, so on its own it can only give an early look.

Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research, Multiple sclerosis research.

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.