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: August 25, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

4

Condition

Psoriasis And Psoriatic Disorders

Diabetes Prevention

Joint Injuries

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:
February 28, 2027

Connect with a study center

  • Reuviva Research Center

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Reuviva Research Center

    Guaynabo 4565119, 00968
    Puerto Rico

    Active - Recruiting

  • Caribbean Medical Research Center

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Caribbean Medical Research Center

    San Juan 4568127, 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

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

    Avondale 5552301, Arizona 5551752 85392
    United States

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

    Chandler 5289282, Arizona 5551752 85225
    United States

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

    Flagstaff 5294810, Arizona 5551752 86001
    United States

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

    Gilbert 5295903, Arizona 5551752 85297
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  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

    Glendale 5295985, Arizona 5551752 85306
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  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

    Mesa 5304391, Arizona 5551752 85210
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  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

    Phoenix 5308655, Arizona 5551752 85032
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  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

    Sun City 5316201, Arizona 5551752 85351
    United States

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

    Tucson 5318313, Arizona 5551752 85704
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  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

    Tucson 5318313, Arizona 5551752 85748
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    Apple Valley, California 92307
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    Covina, California 91722
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    Huntington Beach, California 92648
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    La Mesa, California 91942
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    Riverside, California 92508
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    San Diego, California 92128
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    Santa Monica, California 90404
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    Temecula, California 92592
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    Tujunga, California 91042
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    Whittier, California 90602
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    Apple Valley 5324363, California 5332921 92307
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    Covina 5340175, California 5332921 91722
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    Huntington Beach 5358705, California 5332921 92648
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    La Mesa 5363990, California 5332921 91942
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  • Providence Saint John's Medical Foundation

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    Temecula 5401395, California 5332921 92592
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  • Medvin Clinical Research - Tujunga

    Tujunga 5403767, California 5332921 91042
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  • Medvin Clinical Research - Whittier

    Whittier 5409059, California 5332921 90602
    United States

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    United States

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    Kissimmee, Florida 34741
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    Margate, Florida 33063
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    Miami Beach, Florida 33140
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    Ocoee, Florida 34761
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    Site Not Available

  • Vitalia Medical Research

    Palm Beach Gardens, Florida 33410
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  • International Center for Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Vida Clinical Research

    Kissimmee 4160983, Florida 4155751 34741
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  • Life Clinical Trials

    Margate 4163407, Florida 4155751 33063
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  • CZ Rheumatology

    Miami Beach 4164143, Florida 4155751 33140
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  • Vitalia Medical Research

    Palm Beach Gardens 4167519, Florida 4155751 33410
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    Tampa 4174757, Florida 4155751 33614
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  • Conquest Research

    Winter Park 4178560, Florida 4155751 32789
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    Marietta, Georgia 30060
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    Waycross, Georgia 31501
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    Marietta 4207783, Georgia 4197000 30060
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  • Satilla Rheumatology & Internal Medicine

    Waycross 4229763, Georgia 4197000 31501
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    Chicago, Illinois 60640
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    Schaumburg, Illinois 60195
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    Skokie, Illinois 60076
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    Willowbrook, Illinois 60527
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  • Great Lakes Clinical Trials - Ravenswood

    Chicago 4887398, Illinois 4896861 60640
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    Active - Recruiting

  • Greater Chicago Specialty Physicians

    Schaumburg 4910713, Illinois 4896861 60195
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  • Arnold Arthritis & Rheumatology

    Skokie 4911600, Illinois 4896861 60076
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  • Willow Rheumatology and Wellness PLLC

    Willowbrook 4916709, Illinois 4896861 60527
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  • Lake Cumberland Rheumatology

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Lake Cumberland Rheumatology

    New Albany 4262045, Indiana 4921868 47150
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  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana 70605
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    Site Not Available

  • Accurate Clinical Research, Inc

    Lake Charles 4330236, Louisiana 4331987 70605
    United States

    Active - Recruiting

  • 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

  • Klein & Associates, M.D., P.A.

    Cumberland 4352681, Maryland 4361885 21502
    United States

    Active - Recruiting

  • Klein & Associates, M.D., P.A.

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores 5010978, Michigan 5001836 48081
    United States

    Active - Recruiting

  • Logan Health Research

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Logan Health Rheumatology

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Logan Health Rheumatology

    Kalispell 5660340, Montana 5667009 59901
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14642
    United States

    Active - Recruiting

  • Onsite Clinical Solutions, LLC - Brenner Ave

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Onsite Clinical Solutions, LLC - Brenner Ave

    Salisbury 4489985, North Carolina 4482348 28144
    United States

    Active - Recruiting

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Active - Recruiting

  • Essential Medical Research

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Essential Medical Research

    Tulsa 4553433, Oklahoma 4544379 74137
    United States

    Active - Recruiting

  • 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

  • West Tennessee Research Institute

    Jackson 4632595, Tennessee 4662168 38305
    United States

    Active - Recruiting

  • AARA Clinical Research - Murfreesboro Medical Clinic

    Murfreesboro 4644312, Tennessee 4662168 37128
    United States

    Active - Recruiting

  • Precision Comprehensive Clinical Research Solutions - Colleyville

    Colleyville, Texas 76034
    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

    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

  • SouthWest Rheumatology Research, LLC

    Mesquite, Texas 75150
    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

  • Precision Comprehensive Clinical Research Solutions - Colleyville

    Colleyville 4682478, Texas 4736286 76034
    United States

    Active - Recruiting

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

    Fort Worth 4691930, Texas 4736286 76109
    United States

    Active - Recruiting

  • Accurate Clinical Research, Inc

    Houston 4699066, Texas 4736286 77089
    United States

    Active - Recruiting

  • Research Physicians Network, LLC

    Houston 4699066, Texas 4736286 77089
    United States

    Active - Recruiting

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

    Irving 4700168, Texas 4736286 75039
    United States

    Active - Recruiting

  • Biopharma Informatic, LLC

    Katy 4702732, Texas 4736286 77494
    United States

    Active - Recruiting

  • SouthWest Rheumatology Research, LLC

    Mesquite 4710826, Texas 4736286 75150
    United States

    Site Not Available

  • Advanced Rheumatology of Houston - Woodlands

    The Woodlands 4736476, Texas 4736286 77382
    United States

    Active - Recruiting

  • DM Clinical Research - TRA

    Tomball 4737094, Texas 4736286 77375
    United States

    Active - Recruiting

  • Seattle Rheumatology Associates PLLC

    Seattle, Washington 98104
    United States

    Site Not Available

  • Arthritis Northwest, PLLC

    Spokane, Washington 99204
    United States

    Site Not Available

  • Seattle Rheumatology Associates PLLC

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

  • Arthritis Northwest, PLLC

    Spokane 5811696, Washington 5815135 99204
    United States

    Active - Recruiting

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