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The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
Plain-language guide to NCT01460069: not phased randomized trial of Liraglutide, psoriasis and psoriatic arthritis, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01460069
- Phase
- not phased
- Status
- completed
- Start
- 2011-10
- Completion (planned or actual)
- 2013-05
- Participants
- 20 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Psoriasis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Liraglutide for psoriasis and psoriatic arthritis.
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.
It had two arms (groups): Victoza treatment (active comparator) and Placebo (placebo comparator).
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.
The registry classes the interventions as drug.
Who Took Part
20 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Caucasians above 18 years of age. 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.
The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: psoriasis arthritis; type 1 diabetes; treatment for type 2 diabetes with glp-1-based medicine (ddp-4-inhibitors or glp-1-receptor-agonists).
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
The psoriasis and psoriatic arthritis participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
The Liraglutide group and the comparison group ran side by side rather than switching.
As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2011-10 with completion listed for 2013-05.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: 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).
It also tracked 3 secondary outcomes, for example Body mass index, CRP and Skin biopsies.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Liraglutide in 20 people with psoriasis and psoriatic arthritis.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, Psoriasis and psoriatic arthritis research.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.