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Tirzepatide After Ixekizumab in Psoriatic Arthritis and Obesity
NCT06864026Phase 4
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2025
- Primary completion
- Aug 2027
- Countries
- 2
- Sponsor
- Eli Lilly and Company
- Drugs
- tirzepatide
- Conditions
- psoriatic arthritis (PsA)obesity
01
Overview
Phase 4, open-label, single-arm trial of tirzepatide in psoriatic arthritis (PsA) and obesity, sponsored by Eli Lilly and Company. Primary endpoints: Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index ≤0.5 at 12 months and Percentage of Participants Achieving at Least a 10% Weight Loss at 12 months. Started Mar 2025; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
03
Who it enrols
Adults with active psoriatic arthritis and BMI >= 30 (or >= 27 with a weight-related comorbidity) who have been on ixekizumab for 2-4 months. Excludes patients with prior GLP-1 RA exposure, type 1 diabetes, history of pancreatitis, medullary thyroid cancer, or severe GI complications.
04
Endpoints
Primary
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index ≤0.5
Percentage of Participants Achieving at Least a 10% Weight Loss
Secondary
Percentage of Participants Achieving Tender Joint Count ≤1
Percentage of Participants Achieving Swollen Joint Count ≤1
Percentage of Participants Achieving Body Surface Area ≤3%
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score ≤2
Percentage of Participants Achieving Patient Pain Visual Analogue Scale ≤15
Percentage of Participants Achieving Physician Global Assessment of Disease Activity NRS ≤2
Percentage of Participants Achieving HAQ-DI Score ≤0.5 and at Least a 10% Weight Loss
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy - Fatigue With ≥4-point Increase from Baseline
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