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Liraglutide Use in Prader-Willi Syndrome
Plain-language guide to NCT01542242: phase 4 interventional trial of Liraglutide, 1 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01542242
- Phase
- phase 4
- Status
- terminated early
- Start
- 2012-02
- Completion (planned or actual)
- 2013-03
- Participants
- 1 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus Type 2; Prader Willi Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Liraglutide.
Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes.
Liraglutide use in the treatment of PWS is limited to one case report by Cyganek et el (See attached Citation).
It had 1 arm (groups): Liraglutide (experimental).
Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 1 actual participants took part.
It was open to men only aged from 19 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Prader Willi Syndrome, Diabetes Type 2.
The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: previous or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia syndrome; subjects with acute or chronic pancreatitis.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-02 with completion listed for 2013-03.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Hemoglobin A1C (time frame: Change from baseline in A1C at 12 months).
It also tracked 6 secondary outcomes, for example Fasting Blood Glucose (mmol/L), Fasting Blood Insulin level, Body Weight (kg), Fasting Lipid Profile, Hip Circumference (cm) and Total Body Adipose Tissue Distribution (whole body Computed Tomography).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Liraglutide in 1 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.