The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
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ClinicalTrials.gov Identifier: NCT01460069 |
Recruitment Status :
Completed
First Posted : October 26, 2011
Last Update Posted : June 21, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis | Drug: liraglutide Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of GLP-1 in Psoriasis |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Victoza treatment |
Drug: liraglutide
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. |
Placebo Comparator: 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.
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Drug: Placebo
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. |
- PASI (psoriasis area and severity index) [ Time Frame: Baseline and after 2 months ]
- DLQI (dermatology life quality index) [ Time Frame: Baseline and after 2 months ]
- Body mass index [ Time Frame: Baseline and after 2 months ]
- CRP [ Time Frame: Baseline and after 2 months ]
- Skin biopsies [ Time Frame: Baseline and after 2 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460069
Denmark | |
Gentofte Hospital | |
Hellerup, Denmark, 2900 |
Principal Investigator: | AnneSofie Faurschou, MD PhD | Gentofte Hospital |
Responsible Party: | Annesofie Faurschou, MD PhD - Resident in dermatology, University Hospital, Gentofte, Copenhagen |
ClinicalTrials.gov Identifier: | NCT01460069 |
Other Study ID Numbers: |
2011-000571-13 |
First Posted: | October 26, 2011 Key Record Dates |
Last Update Posted: | June 21, 2013 |
Last Verified: | June 2013 |
psoriasis liraglutide morbidity PASI DLQI |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Liraglutide Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |