Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Completed · Phase 3

Conditions studied: Psoriasis, Obesity

In brief

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis 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 psoriasis 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

NCT06588283

Run by

Eli Lilly and Company

People needed

281

Starts

2024-09-30

Expected to finish

2026-06-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months.
• Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12.
• Have ≥10% body surface area (BSA) involvement.
• 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 serious disorder or illness other than PsO.
• Have a history of chronic or acute pancreatitis.
• Have any prior use of ixekizumab or tirzepatide.
• 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

• Medical Dermatology Specialists — Phoenix, Arizona, United States
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States
• Yuma Clinical Trials — Yuma, Arizona, United States
• Johnson Dermatology — Fort Smith, Arkansas, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• First OC Dermatology Research Inc — Fountain Valley, California, United States
• Avance Clinical Trials — Laguna Niguel, California, United States
• Metropolis Dermatology — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Northridge Clinical Trials — Northridge, California, United States
• Cura Clinical Research - Oxnard — Oxnard, California, United States
• Integrative Skin Science and Research - Location 2 — Sacramento, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Life Clinical Trials — Coral Springs, Florida, United States
• Alliance for Multispecialty Research, LLC — Fort Myers, Florida, United States
• NeoClinical Research — Hialeah, Florida, United States
• Skin Care Research — Hollywood, Florida, United States
• Encore Medical Research — Hollywood, Florida, United States
• Solutions Through Advanced Research — Jacksonville, Florida, United States
• Deluxe Health Center — Miami Lakes, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Leading Edge Dermatology — Plantation, Florida, United States
• International Clinical Research - Sanford — Sanford, Florida, United States
• Nodal Medical Center — Tampa, Florida, United States
• Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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