CompletedPhase 3

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

United States, Puerto Rico279 participantsStarted 2024-09-24

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: 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. * H…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction

Timeframe: Baseline up to Week 36

Trial details

NCT IDNCT06588296

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-18

View on ClinicalTrials.gov More Psoriatic Arthritis trials