Recruiting

GLP-1 & Counseling

Sponsor:

Medical College of Wisconsin

Code:

NCT07111494

Conditions

Psoriatic Arthritis (PsA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GLP-1 agonists

Nutrition Counseling

Study Details

Brief 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.

Conditions

Psoriatic Arthritis (PsA)

Study ID

NCT07111494

Start date

May 1, 2026

Status verified date

Aug, 2026

Completion date

Oct 15, 2028

Anticipated

Primary completion date

Oct 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: GLP-1

active comparator: Nutrition Counseling

Interventions

GLP-1 agonists

GLP-1, any assigned drug

Nutrition Counseling

Nutrition Counseling in PsA

Primary outcome measure

  • Change from the baseline Minimal Disease Activity (MDA) Scores at Week 12 and 24 with GLP-1 Agonists vs Nutrition Counseling [ Time Frame: Week 12 and 24 ]
  • Proportion of Patients who Achieve Disease Activity in Psoriatic Arthritis (DAPSA) Remission with GLP-1 Agonists Vs. Nutrition Counseling at Week 12 and 24 [ Time Frame: Week 12 and 24 ]

Central Contacts and Locations

Locations

Medical College of Wisconsin/Froedtert Hosptial

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Shikha Singla, MD

414-955-7040ssingla@mcw.edu

Kiley Timler

ktimler@mcw.edu

Principal Investigator:

Shikha Singla, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Psoriatic Arthritis
  • GLP-1
  • Minimal Disease Activity
  • Nutrition Counseling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-08-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.