Investigating the effectiveness of tirzepatide added to ixekizumab for psoriasis and obesity
A Phase 4, Prospective, Open-Label, Single Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight in Clinical Practice
This study is testing if adding a weight-loss medication called tirzepatide to an existing psoriasis treatment can help people with moderate-to-severe plaque psoriasis who are also overweight or obese.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | ixekizumab |
| Locations | 43 sites (Phoenix, Arizona and 42 other locations) |
| Trial ID | NCT06857942 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how effective the addition of tirzepatide is when used alongside ixekizumab in patients with moderate-to-severe plaque psoriasis who are also overweight or obese. Participants must have been on ixekizumab for about three months before starting tirzepatide. The study will last for up to 12 months and will take place in standard clinical practice settings. The focus is on patients who have at least one weight-related comorbidity.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with moderate-to-severe plaque psoriasis and a BMI of 27 or greater, who have been on ixekizumab for approximately three months.
Not a fit: Patients who have been on ixekizumab for more than four months or have previously used tirzepatide or similar medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with psoriasis and obesity, potentially leading to better management of both conditions.
How similar studies have performed: While this specific combination has not been extensively tested, similar approaches using other GLP-1 receptor agonists have shown promise in managing obesity-related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant) * Have body mass index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m² to \<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular diseases). * Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide. * Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline/screening). Exclusion Criteria: * Have currently received ixekizumab for more than 4 months or less than 2 months. * Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide. * Are currently enrolled in any other clinical study. Other exclusions * Have a known hypersensitivity to tirzepatide or to any of its component. * Have a personal or family history of medullary thyroid cancer. * Have multiple endocrine neoplasia type 2. * Have type I diabetes mellitus. * Have a history of chronic or acute pancreatitis at any time before screening (Visit 1). * Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment. * Have a history of ketoacidosis or hyperosmolar state/coma. * Have a history of severe hypoglycemia and hypoglycemia unawareness within the 6 months before screening. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.
Where this trial is running
Phoenix, Arizona and 42 other locations
- Medical Dermatology Specialists — Phoenix, Arizona, United States (Recruiting)
- First OC Dermatology Research Inc — Fountain Valley, California, United States (Recruiting)
- Center For Dermatology Clinical Research, Inc. — Fremont, California, United States (Recruiting)
- Metropolis Dermatology — Los Angeles, California, United States (Recruiting)
- Northridge Clinical Trials — Northridge, California, United States (Recruiting)
- Alliance for Multispecialty Research, LLC — Fort Myers, Florida, United States (Recruiting)
- NeoClinical Research — Hialeah, Florida, United States (Recruiting)
- Skin Care Research — Hollywood, Florida, United States (Recruiting)
- Encore Medical Research — Hollywood, Florida, United States (Recruiting)
- MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research — Tampa, Florida, United States (Recruiting)
- TruDerm & TruSpa — Wellington, Florida, United States (Recruiting)
- Southeast Research Specialists — Douglasville, Georgia, United States (Recruiting)
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (Recruiting)
- The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States (Recruiting)
- Equity Medical - Bowling Green — Bowling Green, Kentucky, United States (Recruiting)
- Dermatology and Skin Cancer Specialists, LLC — Rockville, Maryland, United States (Recruiting)
- Metro Boston Clinical Partners — Brighton, Massachusetts, United States (Recruiting)
- David Fivenson, MD, PLC — Ann Arbor, Michigan, United States (Recruiting)
- Great Lakes Research Group, Inc. — Bay City, Michigan, United States (Recruiting)
- The Derm Institute of West Michigan — Caledonia, Michigan, United States (Recruiting)
- Skin Cancer and Dermatology Institute - Reno — Reno, Nevada, United States (Recruiting)
- Stracskin — Portsmouth, New Hampshire, United States (Recruiting)
- Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States (Recruiting)
- Care Access - Hoboken — Hoboken, New Jersey, United States (Recruiting)
- Equity Medical — New York, New York, United States (Recruiting)
- Revival Research Institute, LLC — Cary, North Carolina, United States (Recruiting)
- Onsite Clinical Solutions - Huntersville — Huntersville, North Carolina, United States (Recruiting)
- Optima Research - Boardman — Boardman, Ohio, United States (Recruiting)
- Oregon Dermatology and Research Center — Portland, Oregon, United States (Recruiting)
- Dermatology Associates of Plymouth Meeting — Plymouth Meeting, Pennsylvania, United States (Recruiting)
- Columbia Dermatology & Aesthetics — Columbia, South Carolina, United States (Recruiting)
- Alliance for Multispecialty Research, LLC — Myrtle Beach, South Carolina, United States (Recruiting)
- DelRicht Research - Thompson's Station — Smyrna, Tennessee, United States (Recruiting)
- Bellaire Dermatology Associates — Bellaire, Texas, United States (Recruiting)
- Modern Research Associates, PLLC — Dallas, Texas, United States (Recruiting)
- Center for Clinical Studies — Houston, Texas, United States (Recruiting)
- Austin Institute for Clinical Research — Pflugerville, Texas, United States (Recruiting)
- Texas Dermatology and Laser Specialists — San Antonio, Texas, United States (Recruiting)
- Center for Clinical Studies — Webster, Texas, United States (Recruiting)
- Tanner Clinic — Layton, Utah, United States (Recruiting)
- Bellevue Dermatology Clinic — Bellevue, Washington, United States (Recruiting)
- Dermatology of Seattle — Burien, Washington, United States (Recruiting)
- Office of Dr. Alma M. Cruz — Carolina, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.