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

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Drug: Placebo; Drug: liraglutide

• Registration Number: NCT01460069
• Lead Sponsor: Annesofie Faurschou

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-26
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Victoza treatment	liraglutide	-

Primary Outcome Measures

Name	Time	Method
PASI (psoriasis area and severity index)	Baseline and after 2 months
DLQI (dermatology life quality index)	Baseline and after 2 months

Secondary Outcome Measures

Name	Time	Method
Body mass index	Baseline and after 2 months
CRP	Baseline and after 2 months
Skin biopsies	Baseline and after 2 months

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Hellerup, Denmark