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NCT06864026PHASE4Recruiting

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)

Eli Lilly and Company

Start Date

3/6/2025

Completion Date

11/1/2027

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 active PsA 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 active psoriatic arthritis (PsA) as defined by a rheumatologist or 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-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease). * Who have been treated 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 or screening). 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) receptor agonist (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, or nonproliferative 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 before screening. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

Interventions

DRUG

Tirzepatide

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Psoriatic ArthritisOverweight or Obesity

Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona 85392

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona 85225

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona 86001

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona 85297

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona 85306

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona 85210

United States

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

Phoenix, Arizona 85032

United States

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

Sun City, Arizona 85351

United States

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona 85704

United States

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

Tucson, Arizona 85748

United States

Medvin Clinical Research - Apple Valley

Apple Valley, California 92307

United States

Medvin Clinical Research - Covina

Covina, California 91722

United States

Newport Huntington Medical Group

Huntington Beach, California 92648

United States

Purushotham & Akther Kotha MD, Inc

La Mesa, California 91942

United States

Medvin Clinical Research - Riverside

Riverside, California 92508

United States

Rheumatology Center of San Diego

San Diego, California 92128

United States

Providence Saint John's Medical Foundation

Santa Monica, California 90404

United States

Medvin Clinical Research - Temecula

Temecula, California 92592

United States

Medvin Clinical Research - Tujunga

Tujunga, California 91042

United States

Medvin Clinical Research - Whittier

Whittier, California 90602

United States

Vida Clinical Research

Kissimmee, Florida 34741

United States

Life Clinical Trials

Margate, Florida 33063

United States

CZ Rheumatology

Miami Beach, Florida 33140

United States

Vitalia Medical Research

Palm Beach Gardens, Florida 33410

United States

International Center for Research

Tampa, Florida 33614

United States

Atlanta Research Center for Rheumatology

Marietta, Georgia 30060

United States

Satilla Rheumatology & Internal Medicine

Waycross, Georgia 31501

United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois 60640

United States

Greater Chicago Specialty Physicians

Schaumburg, Illinois 60195

United States

Arnold Arthritis & Rheumatology

Skokie, Illinois 60076

United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois 60527

United States

Lake Cumberland Rheumatology

New Albany, Indiana 47150

United States

Accurate Clinical Research, Inc

Lake Charles, Louisiana 70605

United States

Klein & Associates, M.D., P.A.

Cumberland, Maryland 21502

United States

Klein & Associates, M.D., P.A.

Hagerstown, Maryland 21740

United States

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan 48081

United States

Logan Health Rheumatology

Kalispell, Montana 59901

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury, North Carolina 28144

United States

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio 44130

United States

Essential Medical Research

Tulsa, Oklahoma 74137

United States

West Tennessee Research Institute

Jackson, Tennessee 38305

United States

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee 37128

United States

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville, Texas 76034

United States

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

Fort Worth, Texas 76109

United States

Accurate Clinical Research, Inc

Houston, Texas 77089

United States

Research Physicians Network, LLC

Houston, Texas 77089

United States

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

Irving, Texas 75039

United States

Biopharma Informatic, LLC

Katy, Texas 77494

United States

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas 77382

United States

DM Clinical Research - TRA

Tomball, Texas 77375

United States

Seattle Rheumatology Associates PLLC

Seattle, Washington 98104

United States

Arthritis Northwest, PLLC

Spokane Valley, Washington 99216

United States

Reuviva Research Center

Guaynabo, 00968

Puerto Rico

CMRC Headlands, LLC

San Juan, 00918

Puerto Rico