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

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Psoriatic Arthritis

Hypertriglyceridemia

Treatment

Tirzepatide

Ixekizumab

Clinical Study ID

NCT06588296
27241
I1F-MC-RHDB
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) forat 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 atleast 3 of 66 swollen joints.

  • Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) oroverweight (BMI ≥27 to <30 kg/m²) in the presence of at least 1 of theseweight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleepapnea, cardiovascular disease, or T2DM).

Exclusion

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 multipleendocrine neoplasia (MEN) syndrome type 2.

  • Have active, or a history of inflammatory bowel disease (Crohn's or ulcerativecolitis).

  • Have a diagnosis or history of malignant disease within the 5 years prior torandomization, with the following exceptions:

  • basal cell or squamous epithelial carcinomas of the skin that have beenresected, with no evidence of metastatic disease for 3 years.

  • cervical carcinoma in situ, with no evidence of recurrence within the 5 yearsprior 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) orglucagon-like peptide 1 (GLP-1) receptor agonists.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 3
Study Start date:
September 24, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Centro Reumatologico Caguas

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Reuviva Research Center

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Caribbean Medical Research Center

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Mindful Medical Research

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

    Avondale, Arizona 85392
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix West

    Avondale, Arizona 85392
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

    Chandler, Arizona 85225
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

    Glendale, Arizona 85306
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

    Mesa, Arizona 85210
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix West

    Phoenix, Arizona 85037
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

    Sun City, Arizona 85351
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

    Tucson, Arizona 85704
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

    Tucson, Arizona 85748
    United States

    Site Not Available

  • Medvin Clinical Research - Apple Valley

    Apple Valley, California 92307
    United States

    Site Not Available

  • Medvin Clinical Research - Covina

    Covina, California 91722
    United States

    Site Not Available

  • Newport Huntington Medical Group

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Purushotham & Akther Kotha MD, Inc

    La Mesa, California 91942
    United States

    Site Not Available

  • Medvin Clinical Research - Riverside

    Riverside, California 92508
    United States

    Site Not Available

  • Rheumatology Center of San Diego

    San Diego, California 92128
    United States

    Site Not Available

  • Medvin Clinical Research - Temecula

    Temecula, California 92592
    United States

    Site Not Available

  • Cohen Medical Centers

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Medvin Clinical Research - Tujunga

    Tujunga, California 91042
    United States

    Site Not Available

  • Medvin Clinical Research - Whittier

    Whittier, California 90602
    United States

    Site Not Available

  • Denver Arthritis Clinic

    Denver, Colorado 80230
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida 33765
    United States

    Site Not Available

  • NeoClinical Research

    Hialeah, Florida 33016
    United States

    Site Not Available

  • South Florida Rheumatology

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Vida Clinical Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Life Clinical Trials

    Margate, Florida 33063
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Vitalia Medical Research

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • Sarasota Arthritis Center

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • International Center for Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Bingham Memorial Hospital

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • St. Luke's Clinic

    Boise, Idaho 83702
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Hinsdale Orthopaedics - Illinois Bone & Joint Institute

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Greater Chicago Specialty Physicians

    Schaumburg, Illinois 60195
    United States

    Site Not Available

  • Arnold Arthritis & Rheumatology

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Klein & Associates, M.D., P.A.

    Cumberland, Maryland 21502
    United States

    Site Not Available

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • NECCR PrimaCare Research

    Fall River, Massachusetts 02721
    United States

    Site Not Available

  • Advanced Rheumatology, PC

    Okemos, Michigan 48864
    United States

    Site Not Available

  • Saint Paul Rheumatology

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • AARA Clinical Research - Kansas City Physician Partners - North

    Kansas City, Missouri 64151
    United States

    Site Not Available

  • Arthritis Consultants, Inc.

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Logan Health Research

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Inspire Santa Fe Medical Group

    Santa Fe, New Mexico 87505
    United States

    Site Not Available

  • St. Lawrence Health System

    Canton, New York 13617
    United States

    Site Not Available

  • Buffalo Rheumatology and Medicine

    Orchard Park, New York 14127
    United States

    Site Not Available

  • Onsite Clinical Solutions, LLC - Brenner Ave

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • RAO Research LLC

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Essential Medical Research

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Summit Headlands

    Portland, Oregon 97210
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • AARA Clinical Research - Murfreesboro Medical Clinic

    Murfreesboro, Tennessee 37128
    United States

    Site Not Available

  • Tekton Research, LLC.

    Austin, Texas 78745
    United States

    Site Not Available

  • Accurate Clinical Management, LLC

    Baytown, Texas 77521
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions - Colleyville

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Arthritis Care of Texas

    Corpus Christi, Texas 78415
    United States

    Site Not Available

  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth

    Fort Worth, Texas 76109
    United States

    Site Not Available

  • Accurate Clinical Research, Inc

    Houston, Texas 77089
    United States

    Site Not Available

  • Laila A Hassan, MD, PA

    Houston, Texas 77089
    United States

    Active - Recruiting

  • Research Physicians Network, LLC

    Houston, Texas 77089
    United States

    Site Not Available

  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving

    Irving, Texas 75039
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Katy, Texas 77494
    United States

    Site Not Available

  • Houston Rheumatology & Arthritis Specialists

    Katy, Texas 77494
    United States

    Active - Recruiting

  • West Texas Clinical Research

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Valley Arthritis Center

    McAllen, Texas 78501
    United States

    Site Not Available

  • SouthWest Rheumatology Research, LLC

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Trinity Universal Research Associates

    Plano, Texas 75024
    United States

    Site Not Available

  • Advanced Rheumatology of Houston - Woodlands

    The Woodlands, Texas 77382
    United States

    Site Not Available

  • DM Clinical Research - TRA

    Tomball, Texas 77375
    United States

    Site Not Available

  • Overlake Arthritis and Osteoporosis Center

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Western Washington Medical Group - Rheumatology, Bothell

    Bothell, Washington 98021
    United States

    Site Not Available

  • Arthritis Northwest, PLLC

    Spokane, Washington 99204
    United States

    Site Not Available

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Site Not Available

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