A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)

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

Phase

4

Condition

Diabetes Prevention

Obesity

Rash

Treatment

Tirzepatide

Clinical Study ID

NCT06857942
27319
I1F-MC-RHDD
  • 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 plaque PsO 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 moderate-to-severe plaque PsO, as defined by a dermatologist orother experienced clinician treated PsO (for example, allergologist, nursepractitioner or physician assistant)

  • Have 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 1weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetesmellitus, obstructive sleep apnea, or cardiovascular diseases).

  • Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month)prior to decision to add tirzepatide.

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

Exclusion

Exclusion Criteria:

  • Have currently received ixekizumab for more than 4 months or less than 2 months.

  • Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptoragonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide.

  • Are currently enrolled in any other clinical study.

Other exclusions

  • Have a known hypersensitivity to tirzepatide or to any of its component.

  • Have a personal or family history of medullary thyroid cancer.

  • Have multiple endocrine neoplasia type 2.

  • Have type I diabetes mellitus.

  • Have a history of chronic or acute pancreatitis at any time before screening (Visit 1).

  • 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 and hypoglycemia unawareness within the 6months before screening.

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Tirzepatide
Phase: 4
Study Start date:
March 19, 2025
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Office of Dr. Alma M. Cruz

    Carolina, 00985
    Puerto Rico

    Site Not Available

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • First OC Dermatology Research Inc

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • NorCal Clinical Research

    Rocklin, California 95765
    United States

    Site Not Available

  • Integrative Skin Science and Research - Location 3

    Sacramento, California 95815
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • NeoClinical Research

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Encore Medical Research

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Southeast Research Specialists

    Douglasville, Georgia 30135
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

  • Dermatology and Skin Cancer Specialists, LLC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • David Fivenson, MD, PLC

    Ann Arbor, Michigan 48103
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • The Derm Institute of West Michigan

    Caledonia, Michigan 49316
    United States

    Active - Recruiting

  • Skin Cancer and Dermatology Institute - Reno

    Reno, Nevada 89509
    United States

    Active - Recruiting

  • Stracskin

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Active - Recruiting

  • Care Access - Hoboken

    Hoboken, New Jersey 07030
    United States

    Active - Recruiting

  • Equity Medical

    New York, New York 10023
    United States

    Active - Recruiting

  • Onsite Clinical Solutions - Huntersville

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Optima Research - Boardman

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Columbia Dermatology & Aesthetics

    Columbia, South Carolina 29212
    United States

    Active - Recruiting

  • DelRicht Research - Thompson's Station

    Smyrna, Tennessee 37167
    United States

    Active - Recruiting

  • Bellaire Dermatology Associates

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Modern Research Associates, PLLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Austin Institute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Tanner Clinic

    Layton, Utah 84041
    United States

    Active - Recruiting

  • Bellevue Dermatology Clinic

    Bellevue, Washington 98104
    United States

    Active - Recruiting

  • Dermatology of Seattle

    Burien, Washington 98168
    United States

    Active - Recruiting

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