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Efficacy and Tolerance of Liraglutide for Weight Loss in Obese Type 2 Diabetic Hemodialysis Patients

Plain-language guide to NCT04529278: phase 2 interventional trial of Liraglutide, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04529278
Phase
phase 2
Status
status unknown
Start
2021-01-18
Completion (planned or actual)
2023-01-17
Participants
18 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Diabetes Mellitus, Type 2; Hemodialysis; Obese
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Liraglutide.

It had 1 arm (groups): Liraglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Patient aged ≥ 18 and \<70. Patient on hemodialysis for more than 6 months. Type 2 diabetic patient. Patient with a BMI\> 30 kg / m2 with a Temporary Contraindication for kidney transplant for renal transplant due to overweight by his graft center. Patient affiliated to a health insurance plan.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: patient with a temporary contraindication for kidney transplant for a cause other than overweight; patient with personal or family history of thyroid medullary cancer; patient with a history of acute or chronic pancreatitis.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-01-18 with completion listed for 2023-01-17.

It ran at 4 sites in France (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight Loss at Week 26 (time frame: Week 26).

It also tracked 7 secondary outcomes, for example Lift of CIT for transplant for obesity, Tolerance of luraglutide, Regulation of blood sugar, Glycemic balance, Hypoglycemia and Evolution of weight.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Liraglutide in 18 people.

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

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

More context: the Liraglutide compound page, all human trials.

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.