Tirzepatide for Psoriasis and Obesity

Recruiting at 39 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 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

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

What data supports the effectiveness of the drug Tirzepatide for treating psoriasis and obesity?

There is a report of improvement in psoriasis during treatment with a similar type of drug (GLP-1 receptor agonist) called exenatide, which suggests that drugs like Tirzepatide might also help with psoriasis, especially in patients with obesity and type 2 diabetes. ^{1 2 3 4 5}

How does the drug Tirzepatide differ from other treatments for psoriasis and obesity?

Tirzepatide is unique because it is primarily known for its use in managing type 2 diabetes and obesity, and it works by mimicking hormones that regulate blood sugar and appetite. Unlike traditional psoriasis treatments, which often focus on skin symptoms, Tirzepatide may offer benefits for psoriasis by addressing underlying metabolic issues related to obesity and diabetes. ^{1 3 6 7 8}

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 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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of weight on the efficacy of biologic therapy in patients with psoriasis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Obesity and psoriasis: from the Medical Board of the National Psoriasis Foundation. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Improvement of psoriasis during exenatide treatment in a patient with diabetes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A multicenter, prospective, observational study examining the impact of risk factors, such as BMI and waist circumference, on quality of life improvement and clinical response in moderate-to-severe plaque-type psoriasis patients treated with infliximab in routine care settings of Greece. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Comparable efficacy and safety of brodalumab in obese and nonobese patients with psoriasis: analysis of two randomized controlled trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Tazarotene in combination with phototherapy. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Early clinical development of tazarotene. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of tazarotene: optimizing clinical results. [2014]