The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis

Study Overview
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Brief Summary
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The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.

Official Title
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The Effect of GLP-1 in Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: liraglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasians above 18 years of age Plaque psoriasis PASI score >10 No treatment or stable treatment of psoriasis during at least 3 months before inclusion Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2 Normal blood pressure Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period ( 5 times the plasma half-life) Exclusion Criteria: Psoriasis arthritis Fasting plasma glucose > 7.5 mmol/L or HbA1c > 7.5% Type 1 diabetes Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists) Heart failure, NYHA class III-IV Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine >150 µM and/or albuminuria Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 x upper normal serum levels) Anaemia Acute or chronic pancreatitis Struma or thyroid cancer Pregnancy or breast feeding Inability to complete the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Victoza treatment<br> | Drug: liraglutide<br>* Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15). Commercial pens will be used and the information given in the packaging will be applicable. The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. The injection is administered once daily in the morning. The maximal plasma concentration is reached 8-12 hours after subcutaneous injection. The half-life in plasma is approximately 13 hours. The duration of effect is 24 hours.<br>|
| Placebo Comparator: Placebo<br>The placebo pens contain saline and are administered in the same way and volume as Victoza. The placebo pens are specially prepared for this study and will be used in the study only. | Drug: Placebo<br>* The placebo pens contain saline and are administered in the same way and volume as (liraglutide) Victoza. The placebo pens are specially prepared for this study and will be used in the study only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI (psoriasis area and severity index) |  | Baseline and after 2 months | 
| DLQI (dermatology life quality index) |  | Baseline and after 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  | Baseline and after 2 months | 
| CRP |  | Baseline and after 2 months | 
| Skin biopsies |  | Baseline and after 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, liraglutide, morbidity, PASI, DLQI