Tirzepatide for Psoriatic Arthritis

Recruiting at 58 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Eli Lilly and Company

Must be taking: Ixekizumab

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Type 1 diabetes, Pancreatitis, Thyroid cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe PsA and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have been on ixekizumab for about 3 months before starting tirzepatide, and you cannot have used tirzepatide or similar medications before.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for people with active Psoriatic Arthritis (PsA) who are also overweight or obese and have at least one weight-related health issue. Participants should already be receiving ixekizumab therapy as part of their standard care.

Inclusion Criteria

I can start tirzepatide within 30 days of deciding to treat.

I have been diagnosed with active psoriatic arthritis by a specialist.

I have been treated with ixekizumab for about 3 months before starting tirzepatide.

Exclusion Criteria

I have had pancreatitis before.

I have had severe stomach or digestion problems like gastroparesis or GERD.

Are currently enrolled in any other clinical study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue on ixekizumab and take tirzepatide administered subcutaneously as per label

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tirzepatide

Trial Overview The study tests the effectiveness of adding a medication called tirzepatide to existing ixekizumab treatment in patients with PsA and obesity over a period of up to 12 months, observing how well it works in regular clinical settings.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University