Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A P… (NCT07111494) | Clinical Trial Compass
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
United States22 participantsStarted 2026-05-01
Plain-language summary
Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body. This study will assess if the effectiveness of Glucagon-like peptide-1 (GLP-1) medications used to treat type 2-diabetes and weight management, or nutrition counseling can better treat individuals with Psoriatic Arthritis who are also needing treatment for obesity and type 2 diabetes.
The main objectives it aims to answer are:
To assess disease outcomes of PsA patients undergoing treatment for concomitant obesity and type 2 diabetes with GLP-1 analogs vs nutrition counseling.
To assess effectiveness as measured by clinical and patient reported outcome measures in patients treated with GLP-1 and nutrition counseling.
Participants will be randomized to receive a GLP-1 or nutrition counseling. Participants will be asked to come to the study center at most four times during a 24-week period. During this time participants will be asked to fill out questionnaires, receive a physical exam, and have their blood drawn.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (age 18 and older) who present to rheumatology clinic
* Participants must be able to read, understand, and provide documented informed consent as approved by the Institutional Review Board (IRB).
* Meet the Classification of Psoriatic Arthritis (CASPAR) criteria for PsA
* Participants must have a Body Mass Index (BMI) of 30kg/m\^2
* Participants must be treated for PsA in accordance with guidelines
* Have not achieved MDA in PsA patients
* Have a minimum TJC \> 1 and SJC \> at baseline
* Eligible for GLP-1 agonist treatment in accordance with Food Drug Administration (FDA) labeling as determined by the investigator.
Exclusion Criteria:
* Any prior use of GLP-1 agonists
* Inability to provide informed consent
* Current participation in another PsA study
* Treatment initiation by GLP-1 agonists contraindicated by FDA
* Patients with hemoglobin A1c (HbA1c) \> 10 at baseline
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from the baseline Minimal Disease Activity (MDA) Scores at Week 12 and 24 with GLP-1 Agonists vs Nutrition Counseling
Timeframe: Week 12 and 24
2
Proportion of Patients who Achieve Disease Activity in Psoriatic Arthritis (DAPSA) Remission with GLP-1 Agonists Vs. Nutrition Counseling at Week 12 and 24