Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial

NCT ID: NCT07111494

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2028-10-15

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLP-1

Group Type: ACTIVE_COMPARATOR

GLP-1 agonists

Intervention Type: DRUG

GLP-1, any assigned drug

Nutrition Counseling

Group Type: ACTIVE_COMPARATOR

Nutrition Counseling

Intervention Type: OTHER

Nutrition Counseling in PsA

Interventions

GLP-1 agonists

GLP-1, any assigned drug

Intervention Type: DRUG

Nutrition Counseling

Nutrition Counseling in PsA

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Shikha Singla

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin/Froedtert Hosptial

Milwaukee, Wisconsin, United States

Countries

United States

Facility Contacts

Shikha Singla, MD

Role: primary

ssingla@mcw.edu

414-955-7040

Kiley Timler

Role: backup

ktimler@mcw.edu

Other Identifiers

PRO55130

Identifier Type: -

Identifier Source: org_study_id