Tirzepatide for Psoriasis and Obesity

Recruiting at 48 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 RAs

Disqualifiers: Type I 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 aims to determine if adding tirzepatide, a medication for weight management, to ixekizumab benefits people with moderate-to-severe plaque psoriasis who also face obesity or are overweight with related health issues like high blood pressure or type 2 diabetes. The study will last up to 12 months, monitoring the effectiveness of this treatment combination. Participants should have been taking ixekizumab for about three months and have a body mass index (BMI) of 27 or higher. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and proven effective treatment benefits a broader range of patients.

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 not have taken tirzepatide or similar medications before, and you should have been on ixekizumab for about 3 months before starting tirzepatide.

What is the safety track record for tirzepatide?

Research has shown that tirzepatide is generally safe for people. In a study involving adults with obesity but not diabetes, tirzepatide proved to be safe. The most common side effects were mild, such as nausea and diarrhea, and most people tolerated them well. Additionally, the FDA has already approved tirzepatide for treating type 2 diabetes, supporting its safety profile. People using it for diabetes have not reported any unexpected serious side effects. Overall, current evidence suggests that tirzepatide is safe to use, although individual experiences may vary. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for psoriasis and obesity, which often involve topical steroids, phototherapy, or oral medications, tirzepatide offers a unique approach. Tirzepatide is a peptide that acts as a dual agonist targeting both GIP and GLP-1 receptors, which are involved in regulating glucose and energy balance. This mechanism not only helps with weight reduction but also shows potential in modulating immune responses, which could benefit psoriasis patients. Researchers are excited about tirzepatide because it combines these two actions, potentially offering a more comprehensive treatment option for individuals dealing with both conditions simultaneously.

What evidence suggests that tirzepatide might be an effective treatment for psoriasis and obesity?

Research has shown that tirzepatide aids weight loss in individuals with obesity. One study demonstrated that participants who took tirzepatide weekly lost significant weight over 72 weeks. Another study found that even with slower dosage increases, participants still lost a substantial amount of weight within six months. Continuing tirzepatide helped maintain weight loss, while discontinuation led to weight regain. Although these studies focus on weight loss, this trial will examine how tirzepatide, when combined with ixekizumab, might also benefit psoriasis. Participants in this trial will continue receiving ixekizumab and take tirzepatide subcutaneously according to the label. ^{1 3 6 7 8}

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 moderate-to-severe plaque psoriasis (PsO) who are also overweight or obese, and have at least one weight-related health issue. It's not clear what the specific exclusions are, but typically they would include certain medical conditions or treatments that could interfere with the study.

Inclusion Criteria

I started treatment with ixekizumab about 2-4 months ago.

I have been diagnosed with moderate-to-severe plaque psoriasis.

My BMI is over 27 and I have a weight-related health issue, or it's over 30.

Exclusion Criteria

Are currently enrolled in any other clinical study

Have a known hypersensitivity to tirzepatide or to any of its components

I have had pancreatitis before the first visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ixekizumab and tirzepatide 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 trial is testing if adding a drug called Tirzepatide to another medication named Ixekizumab helps patients with PsO and obesity better than Ixekizumab alone. The study will observe participants for up to one year in a real-world clinical setting.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

Participants will continue to receive ixekizumab and take tirzepatide 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. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06857942

NCT06857942 | A Study to Investigate the 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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39996368/

Real-world use and effectiveness of tirzepatide among ... While tirzepatide dose escalation was slower than in clinical trials, individuals achieved weight reduction at 6 months, consistent with ...

4. nature.com nature.com/articles/s41591-025-03913-2

Tirzepatide leads to weight reduction in people with obesity ... In the treatment arm, the weight loss trajectory over 72 weeks was comparable in both groups: 18.3% weight reduction in MC4R mutation carriers ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2812936

Continued Treatment With Tirzepatide for Maintenance of ... From randomization (at week 36), those switched to placebo experienced a 14% weight regain and those continuing tirzepatide experienced an ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK585056/

Tirzepatide - StatPearls - NCBI Bookshelf Tirzepatide is a novel medication approved by the US Food and Drug Administration (FDA) for treating type 2 diabetes mellitus (T2DM).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06588283

Study Details | NCT06588283 | Ixekizumab Concomitantly ... Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderate-to-Severe Plaque Psoriasis ...

8. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16549

Tirzepatide and cardiometabolic parameters in obesity ... This narrative review summarizes the current evidence regarding the effects of tirzepatide treatment on cardiometabolic parameters.