Liraglutide Use in Prader-Willi Syndrome

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01542242

Enrollment

Registered

2012-03-02

Start date

2012-02-29

Completion date

2013-03-31

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, Prader Willi Syndrome

Keywords

Diabetes Mellitus Type 2, Prader Willi Syndrome

Brief summary

Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive effect and has been associated with weight loss 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). In this case report, the subject showed improvements in hemoglobin A1c and body weight over 14 weeks. The investigators plan to examine the use of liraglutide in a single subject with Prader Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid control.

Interventions

DRUGLiraglutide

Liraglutide 0.6 mg SQ daily for one week, increase to a maximum dose of 1.8 mg SQ daily by 6 weeks, and subsequent continuation for the remainder of a year.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Prader Willi Syndrome, Diabetes Type 2

Exclusion criteria

* Previous or family history of Medullary Carcinoma of the Thyroid or multiple endocrine neoplasia syndrome. * Subjects with acute or chronic Pancreatitis

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1C	Change from baseline in A1C at 12 months

Secondary

Measure	Time frame
Fasting Blood Insulin level	Change from baseline in fasting blood insulin at 12 months
Body Weight (kg)	Change from baseline in body weight at 12 months
Fasting Blood Glucose (mmol/L)	Change from baseline in fasting blood glucose at 12 months
Hip Circumference (cm)	Change from baseline in hip circumference at 12 months
Total Body Adipose Tissue Distribution (whole body Computed Tomography)	Change from baseline in total body adipose tissue distribution at 12 months
Fasting Lipid Profile	Change from baseline in fasting lipid profile at 12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026