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

Annesofie Faurschou

Status: Completed

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT01460069

2011-000571-13

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Victoza treatment

Active Comparator group

Treatment:

Drug: liraglutide

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo