Tirzepatide for Psoriatic Arthritis

Recruiting at 60 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of adding tirzepatide to ixekizumab for individuals with psoriatic arthritis, a condition causing joint pain and skin patches, who are also overweight or obese. The researchers aim to determine if this combination can better manage symptoms in real-world settings. Participants should have used ixekizumab for about three months and have conditions such as high blood pressure or type 2 diabetes. The study will last up to 12 months. As a Phase 4 trial, it involves an FDA-approved treatment, aiming to understand its benefits for a broader patient population.

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.

What is the safety track record for tirzepatide?

Research has shown that tirzepatide is generally safe for people. In earlier studies, participants taking tirzepatide lost more weight than those on a placebo. Although these studies did not focus on safety, they found the side effects of tirzepatide to be manageable.

Common side effects included mild stomach issues like nausea, while serious side effects were rare. The FDA's approval of tirzepatide for other uses provides some confidence in its safety. However, as with any treatment, individual reactions can vary, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tirzepatide is unique because it offers a new approach for treating psoriatic arthritis by combining its effects with the existing medication, ixekizumab. While most treatments focus on reducing inflammation and slowing disease progression, tirzepatide, originally developed for diabetes, also helps manage weight and metabolic issues, which can be beneficial for people with psoriatic arthritis. Researchers are excited about tirzepatide because it works as a dual GIP and GLP-1 receptor agonist, potentially offering a more comprehensive treatment option by addressing both joint symptoms and metabolic health. This dual action could lead to improved overall outcomes for patients.

What evidence suggests that tirzepatide might be an effective treatment for psoriatic arthritis?

Research shows that tirzepatide, the investigational treatment in this trial, can aid weight loss, potentially benefiting people with psoriatic arthritis (PsA). In earlier studies, individuals with obesity who took tirzepatide experienced significant weight loss. Losing weight may alleviate PsA symptoms, as extra weight can worsen joint pain and swelling. Additionally, a recent report found that psoriasis symptoms improved with a reduction in body mass index (BMI). Tirzepatide has proven effective in managing weight, which is crucial for those with PsA. ^{1 3 4 5 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06588296

Study Details | NCT06588296 | Ixekizumab Concomitantly ... The main purpose of this study is to demonstrate that when participants with psoriatic arthritis and obesity or overweight in the presence of at least 1 weight ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06864026

NCT06864026 | A Study to Investigate Effectiveness of ... The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with ...

3. trialx.com trialx.com/clinical-trials/listings/297217/a-study-to-investigate-effectiveness-of-tirzepatide-following-initiation-of-ixekizumab-in-participants-with-active-psoriatic-arthritis-and-overweight-or-obesity-in-clinical-practice-together-amplify-psa/

A Study to Investigate Effectiveness of Tirzepatide ... The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in ...

4. psoriasiscouncil.org psoriasiscouncil.org/commentaries/dermatology-and-metabolic-medicine/

Bridging Dermatology and Metabolic Medicine: The Role of ... The patient achieved a BMI reduction from 40.3 to 38.3 kg/m², with a notable improvement in psoriasis severity. In a recent systematic review, ...

5. withpower.com withpower.com/trial/phase-4-obesity-2-2025-bc4df

Tirzepatide for Psoriatic Arthritis The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1297319X25000636

Weighing in on obesity and psoriatic arthritis – Time to ... Obesity increases the risk of developing PsA, worsens disease activity, pain and fatigue, impairs treatment response, and amplifies the risk of many ...