Investigating tirzepatide's effectiveness with ixekizumab for psoriatic arthritis patients with obesity
A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice.
PHASE4 · Eli Lilly and Company · NCT06864026
This study tests if adding tirzepatide to ixekizumab can help people with psoriatic arthritis who are overweight or obese feel better over a year.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Drugs / interventions | ixekizumab |
| Locations | 55 sites (Avondale, Arizona and 54 other locations) |
| Trial ID | NCT06864026 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of adding tirzepatide to ixekizumab therapy in patients with active psoriatic arthritis who are also overweight or obese. Participants must have been treated with ixekizumab for approximately three months before starting tirzepatide. The study will last up to 12 months and focuses on individuals with at least one weight-related comorbidity. The goal is to assess how this combination therapy can improve patient outcomes in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with active psoriatic arthritis and a BMI indicating overweight or obesity, who have been on ixekizumab for about three months.
Not a fit: Patients who have been on ixekizumab for more than four months or have previously used tirzepatide or other GLP-1 receptor agonists may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment options for patients with psoriatic arthritis and obesity, potentially leading to better management of their conditions.
How similar studies have performed: While this specific combination has not been extensively tested, similar approaches involving 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 active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA. * 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, obstructive sleep apnea, or cardiovascular disease). * Who have been treated 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 or screening). Exclusion Criteria: * Have currently received ixekizumab for more than 4 months or less than 2 months. * Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide). * Are currently enrolled in any other clinical study. * Have a known hypersensitivity to any component of tirzepatide. * Have a personal or family history of medullary thyroid cancer. * Have multiple endocrine neoplasia type 2. * Have type 1 diabetes mellitus. * Have a history of chronic or acute pancreatitis at any time before screening. * 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 unawareness within the 6 months before screening. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.
Where this trial is running
Avondale, Arizona and 54 other locations
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale — Avondale, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler — Chandler, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff — Flagstaff, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert — Gilbert, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa — Mesa, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV — Phoenix, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City — Sun City, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson — Tucson, Arizona, United States (RECRUITING)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast — Tucson, Arizona, United States (RECRUITING)
- Medvin Clinical Research - Apple Valley — Apple Valley, California, United States (RECRUITING)
- Medvin Clinical Research - Covina — Covina, California, United States (RECRUITING)
- Newport Huntington Medical Group — Huntington Beach, California, United States (RECRUITING)
- Purushotham & Akther Kotha MD, Inc — La Mesa, California, United States (RECRUITING)
- Medvin Clinical Research - Riverside — Riverside, California, United States (RECRUITING)
- Rheumatology Center of San Diego — San Diego, California, United States (RECRUITING)
- Providence Saint John's Medical Foundation — Santa Monica, California, United States (RECRUITING)
- Medvin Clinical Research - Temecula — Temecula, California, United States (RECRUITING)
- Medvin Clinical Research - Tujunga — Tujunga, California, United States (RECRUITING)
- Medvin Clinical Research - Whittier — Whittier, California, United States (RECRUITING)
- Vida Clinical Research — Kissimmee, Florida, United States (RECRUITING)
- Life Clinical Trials — Margate, Florida, United States (RECRUITING)
- CZ Rheumatology — Miami Beach, Florida, United States (RECRUITING)
- Vitalia Medical Research — Palm Beach Gardens, Florida, United States (RECRUITING)
- International Center for Research — Tampa, Florida, United States (RECRUITING)
- Atlanta Research Center for Rheumatology — Marietta, Georgia, United States (RECRUITING)
- Satilla Rheumatology & Internal Medicine — Waycross, Georgia, United States (RECRUITING)
- Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States (RECRUITING)
- Greater Chicago Specialty Physicians — Schaumburg, Illinois, United States (RECRUITING)
- Arnold Arthritis & Rheumatology — Skokie, Illinois, United States (RECRUITING)
- Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States (RECRUITING)
- Lake Cumberland Rheumatology — New Albany, Indiana, United States (RECRUITING)
- Accurate Clinical Research, Inc — Lake Charles, Louisiana, United States (RECRUITING)
- Klein & Associates, M.D., P.A. — Cumberland, Maryland, United States (RECRUITING)
- Klein & Associates, M.D., P.A. — Hagerstown, Maryland, United States (RECRUITING)
- Clinical Research Institute of Michigan, LLC — Saint Clair Shores, Michigan, United States (RECRUITING)
- Logan Health Rheumatology — Kalispell, Montana, United States (RECRUITING)
- University of Rochester Medical Center — Rochester, New York, United States (RECRUITING)
- Onsite Clinical Solutions, LLC - Brenner Ave — Salisbury, North Carolina, United States (RECRUITING)
- Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio, United States (RECRUITING)
- Essential Medical Research — Tulsa, Oklahoma, United States (RECRUITING)
- West Tennessee Research Institute — Jackson, Tennessee, United States (RECRUITING)
- AARA Clinical Research - Murfreesboro Medical Clinic — Murfreesboro, Tennessee, United States (RECRUITING)
- Precision Comprehensive Clinical Research Solutions - Colleyville — Colleyville, Texas, United States (RECRUITING)
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth — Fort Worth, Texas, United States (RECRUITING)
- Accurate Clinical Research, Inc — Houston, Texas, United States (RECRUITING)
- Research Physicians Network, LLC — Houston, Texas, United States (RECRUITING)
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving — Irving, Texas, United States (RECRUITING)
- Biopharma Informatic, LLC — Katy, Texas, United States (RECRUITING)
- Advanced Rheumatology of Houston - Woodlands — The Woodlands, Texas, United States (RECRUITING)
+5 more sites — see ClinicalTrials.gov for the full list.
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.
Conditions: Psoriatic Arthritis, Overweight or Obesity