Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQINCT01451905
GLP-1 Receptors in Normal Skin and Skin From Patients With Psoriasis
A study testing Liraglutide in people with Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
4.3 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) 4.4 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 locations and contacts
1 site in 1 country.
Annesofie Faurschou, MD PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Gentofte Hospital
Hellerup, 2900
Lone Skov, Prof, +45 39773977, losk@geh.regionh.dk
About this study
To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease
- Being tested
- Liraglutide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylene glycol, 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.
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Active comparator | Not described Receives: Drug: Liraglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PASI and DLQI
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annesofie Faurschou, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451905
- Sponsor's protocol ID
- GLP1-PSO
- Status last verified
- Jun 2012
- First submitted
- 11 Oct 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 Receptors in Normal Skin and Skin From Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT01451905
- Acronym / sponsor ID
- GLP1-PSO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | Active comparator | Drug: Liraglutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideVictoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylene glycol, 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. | Drug | Psoriasis |
| PlaceboThe 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 | Drug | Placebo |
Primary outcome
Changes in PASI and DLQI
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annesofie Faurschou, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide in people with Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annesofie Faurschou, MD PhD (+45 39773977), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PASI and DLQI (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.