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

Condition(s) targeted: Psoriasis

Intervention: liraglutide (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Annesofie Faurschou

Official(s) and/or principal investigator(s):
AnneSofie Faurschou, MD PhD, Principal Investigator, Affiliation: Gentofte Hospital

Overall contact:
Annesofie Faurschou, MD PhD, Email: afau16@gmail.com

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: The Effect of GLP-1 in Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

PASI (psoriasis area and severity index)

DLQI (dermatology life quality index)

Secondary outcome:

Body mass index

CRP

Skin biopsies

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Annesofie Faurschou, MD PhD, Email: afau16@gmail.com

Gentofte Hospital, Hellerup 2900, Denmark; Recruiting
Lone Skov, Prof, Phone: +45 3977 3977, Email: losk@geh.regionh.dk

Starting date: October 2011
Last updated: October 24, 2011