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NCT06857942PHASE4Recruiting

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)

Eli Lilly and Company

Start Date

3/19/2025

Completion Date

5/1/2028

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

Age Range: 18 years to No maximum

Inclusion Criteria: * Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner 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 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes mellitus, 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 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 receptor agonist (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, or nonproliferative 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 6 months before screening. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.

Interventions

DRUG

Tirzepatide

Interested in This Trial?

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Conditions

PsoriasisOverweight or Obesity

Locations

Medical Dermatology Specialists

Phoenix, Arizona 85006

United States

First OC Dermatology Research Inc

Fountain Valley, California 92708

United States

Center For Dermatology Clinical Research, Inc.

Fremont, California 94538

United States

Metropolis Dermatology

Los Angeles, California 90017

United States

Northridge Clinical Trials

Northridge, California 91325

United States

NeoClinical Research

Hialeah, Florida 33016

United States

Skin Care Research

Hollywood, Florida 33021

United States

Encore Medical Research

Hollywood, Florida 33024

United States

MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

Tampa, Florida 33607

United States

TruDerm & TruSpa

Wellington, Florida 33449

United States

Southeast Research Specialists

Douglasville, Georgia 30135

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

The Indiana Clinical Trials Center, PC

Plainfield, Indiana 46168

United States

Equity Medical - Bowling Green

Bowling Green, Kentucky 42104

United States

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland 20850

United States

Metro Boston Clinical Partners

Brighton, Massachusetts 02135

United States

David Fivenson, MD, PLC

Ann Arbor, Michigan 48103

United States

Great Lakes Research Group, Inc.

Bay City, Michigan 48706

United States

The Derm Institute of West Michigan

Caledonia, Michigan 49316

United States

Skin Cancer and Dermatology Institute - Reno

Reno, Nevada 89509

United States

Stracskin

Portsmouth, New Hampshire 03801

United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey 08520

United States

Care Access - Hoboken

Hoboken, New Jersey 07030

United States

Equity Medical

New York, New York 10023

United States

Revival Research Institute, LLC

Cary, North Carolina 27511

United States

Onsite Clinical Solutions - Huntersville

Huntersville, North Carolina 28078

United States

Optima Research - Boardman

Boardman, Ohio 44512

United States

Oregon Dermatology and Research Center

Portland, Oregon 97210

United States

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania 19462

United States

Columbia Dermatology & Aesthetics

Columbia, South Carolina 29212

United States

DelRicht Research - Thompson's Station

Smyrna, Tennessee 37167

United States

Bellaire Dermatology Associates

Bellaire, Texas 77401

United States

Modern Research Associates, PLLC

Dallas, Texas 75231

United States

Center for Clinical Studies

Houston, Texas 77004

United States

Austin Institute for Clinical Research

Pflugerville, Texas 78660

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas 78218

United States

Center for Clinical Studies

Webster, Texas 77598

United States

Tanner Clinic

Layton, Utah 84041

United States

Bellevue Dermatology Clinic

Bellevue, Washington 98104

United States

Dermatology of Seattle

Burien, Washington 98168

United States