Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

Completed · Phase 3

Conditions studied: Psoriatic Arthritis, Obesity

In brief

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-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriatic arthritis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Key facts

Study ID

NCT06588296

Run by

Eli Lilly and Company

People needed

279

Starts

2024-09-24

Expected to finish

2026-04-23

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and currently fulfilling the classification of Psoriatic Arthritis (CASPAR) criteria.
• Have active PsA, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints.
• Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to <30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM).

You may not qualify if…

• Medical Conditions
• Have Type 1 Diabetes Mellitus (T1DM).
• Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
• Have a prior or planned surgical treatment for obesity.
• Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
• Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
• Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:
• basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
• cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
• Have a serious disorder or illness other than PsA.
• Have a history of chronic or acute pancreatitis.
• Have any prior use of ixekizumab or tirzepatide.
• Diagnosis of other inflammatory arthritis, such as Rheumatoid Arthritis (RA), ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis.
• Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.

Where it is running

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler — Chandler, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff — Flagstaff, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert — Gilbert, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa — Mesa, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV — Phoenix, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City — Sun City, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson — Tucson, Arizona, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast — Tucson, Arizona, United States
• Medvin Clinical Research - Apple Valley — Apple Valley, California, United States
• Medvin Clinical Research - Covina — Covina, California, United States
• Newport Huntington Medical Group — Huntington Beach, California, United States
• Purushotham & Akther Kotha MD, Inc — La Mesa, California, United States
• Medvin Clinical Research - Riverside — Riverside, California, United States
• Rheumatology Center of San Diego — San Diego, California, United States
• Medvin Clinical Research - Temecula — Temecula, California, United States
• Cohen Medical Centers — Thousand Oaks, California, United States
• Medvin Clinical Research - Tujunga — Tujunga, California, United States
• Medvin Clinical Research - Whittier — Whittier, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• NeoClinical Research — Hialeah, Florida, United States
• South Florida Rheumatology — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale — Avondale, Arizona, United States

Full record on ClinicalTrials.gov

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