A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

4

Condition

Joint Injuries

Hypertriglyceridemia

Psoriasis And Psoriatic Disorders

Treatment

Tirzepatide

Clinical Study ID

NCT06864026
27350
I1F-MC-RHDE
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe PsA and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologistor 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-relatedcomorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleepapnea, or cardiovascular disease).

  • Who have been treated with ixekizumab for approximately 3 months (±1 month) prior todecision to add tirzepatide.

  • Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).

Exclusion

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) receptoragonist (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, ornonproliferative 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 beforescreening.

  • Have a history of severe gastrointestinal complications, including gastroparesis,gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Tirzepatide
Phase: 4
Study Start date:
March 06, 2025
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Reuviva Research Center

    Guaynabo, 00968
    Puerto Rico

    Active - Recruiting

  • Caribbean Medical Research Center

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

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

    Avondale, Arizona 85392
    United States

    Site Not Available

  • 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 - 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

    Active - Recruiting

  • Medvin Clinical Research - Covina

    Covina, California 91722
    United States

    Active - Recruiting

  • Newport Huntington Medical Group

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Purushotham & Akther Kotha MD, Inc

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Medvin Clinical Research - Riverside

    Riverside, California 92508
    United States

    Active - Recruiting

  • Rheumatology Center of San Diego

    San Diego, California 92128
    United States

    Active - Recruiting

  • Providence Saint John's Medical Foundation

    Santa Monica, California 90404
    United States

    Site Not Available

  • Medvin Clinical Research - Temecula

    Temecula, California 92592
    United States

    Active - Recruiting

  • Medvin Clinical Research - Tujunga

    Tujunga, California 91042
    United States

    Active - Recruiting

  • Medvin Clinical Research - Whittier

    Whittier, California 90602
    United States

    Active - Recruiting

  • CZ Rheumatology

    Coral Springs, Florida 33065
    United States

    Site Not Available

  • Vida Clinical Research

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Life Clinical Trials

    Margate, Florida 33063
    United States

    Active - Recruiting

  • CZ Rheumatology

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Advanced Clinical Research of Orlando - Ocoee

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Vitalia Medical Research

    Palm Beach Gardens, Florida 33410
    United States

    Active - Recruiting

  • International Center for Research

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Greater Chicago Specialty Physicians

    Schaumburg, Illinois 60195
    United States

    Active - Recruiting

  • Arnold Arthritis & Rheumatology

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Lake Cumberland Rheumatology

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Klein & Associates, M.D., P.A.

    Cumberland, Maryland 21502
    United States

    Active - Recruiting

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Logan Health Research

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Logan Health Rheumatology

    Kalispell, Montana 59901
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Onsite Clinical Solutions, LLC - Brenner Ave

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Essential Medical Research

    Tulsa, Oklahoma 74137
    United States

    Active - Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • AARA Clinical Research - Murfreesboro Medical Clinic

    Murfreesboro, Tennessee 37128
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions - Colleyville

    Colleyville, Texas 76034
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Research Physicians Network, LLC

    Houston, Texas 77089
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • SouthWest Rheumatology Research, LLC

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Advanced Rheumatology of Houston - Woodlands

    The Woodlands, Texas 77382
    United States

    Active - Recruiting

  • DM Clinical Research - TRA

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Seattle Rheumatology Associates PLLC

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Arthritis Northwest, PLLC

    Spokane, Washington 99204
    United States

    Active - Recruiting

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