Recruiting

Tirzepatide & IxekizumabA 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)

Sponsor:

Eli Lilly and Company

Code:

NCT06864026

Conditions

Psoriatic Arthritis

Overweight or Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief 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.

Conditions

Psoriatic Arthritis

Overweight or Obesity

Study ID

NCT06864026

Start date

Mar 6, 2025

Status verified date

Jun, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.

Interventions

Tirzepatide

Administered SC

Primary outcome measure

Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy [ Time Frame: 12 Months ]
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Recruiting

Avondale, Arizona, United States, 85392

Contacts

602-386-4971

Principal Investigator:

Andrew Sharobeem

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Recruiting

Chandler, Arizona, United States, 85225

Contacts

480-443-8400

Principal Investigator:

Amer Al-Khoudari

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Recruiting

Flagstaff, Arizona, United States, 86001

Contacts

928-666-3772

Principal Investigator:

Alexander Hu

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

480-443-8400

Principal Investigator:

Joonhee Lim

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Recruiting

Glendale, Arizona, United States, 85306

Contacts

602-386-4969

Principal Investigator:

Rajat Dhar

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Recruiting

Mesa, Arizona, United States, 85210

Contacts

480-626-6637

Principal Investigator:

Matthew Herrmann

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

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

480-626-6637

Principal Investigator:

Areena Swarup

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

Recruiting

Sun City, Arizona, United States, 85351

Contacts

602-386-4970

Principal Investigator:

Mona Amin

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Recruiting

Tucson, Arizona, United States, 85704

Contacts

520-867-6906

Principal Investigator:

Romy Cabacungan

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

Recruiting

Tucson, Arizona, United States, 85748

Contacts

520-849-8753

Principal Investigator:

Jawad Bilal

Medvin Clinical Research - Apple Valley

Recruiting

Apple Valley, California, United States, 92307

Contacts

909-581-8477

Principal Investigator:

Diraj Karnani

Medvin Clinical Research - Covina

Recruiting

Covina, California, United States, 91722

Contacts

626-869-5730

Principal Investigator:

Samy Metyas

Newport Huntington Medical Group

Recruiting

Huntington Beach, California, United States, 92648

Contacts

714-378-2440

Principal Investigator:

Christine Thai

Purushotham & Akther Kotha MD, Inc

Recruiting

La Mesa, California, United States, 91942

Contacts

619-229-1995 x208

Principal Investigator:

Roshan Kotha

Medvin Clinical Research - Riverside

Recruiting

Riverside, California, United States, 92508

Contacts

(951) 672-1866

Principal Investigator:

Chandrakant Mehta

Rheumatology Center of San Diego

Recruiting

San Diego, California, United States, 92128

Principal Investigator:

Tania Rivera

Providence Saint John's Medical Foundation

Recruiting

Santa Monica, California, United States, 90404

Principal Investigator:

Orrin Troum

Medvin Clinical Research - Temecula

Recruiting

Temecula, California, United States, 92592

Contacts

9516525000

Principal Investigator:

Amal Mehta

Medvin Clinical Research - Tujunga

Recruiting

Tujunga, California, United States, 91042

Contacts

8182652250

Principal Investigator:

DAN LA

Medvin Clinical Research - Whittier

Recruiting

Whittier, California, United States, 90602

Contacts

5627586600

Principal Investigator:

Tien-I Su

Vida Clinical Research

Recruiting

Kissimmee, Florida, United States, 34741

Principal Investigator:

Nimesh Dayal

Life Clinical Trials

Recruiting

Margate, Florida, United States, 33063

Principal Investigator:

Jigar Shah

CZ Rheumatology

Recruiting

Miami Beach, Florida, United States, 33140

Principal Investigator:

Conrad Ziembinski

Vitalia Medical Research

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Contacts

5615591110

Principal Investigator:

Clifford Stermer

International Center for Research

Recruiting

Tampa, Florida, United States, 33614

Principal Investigator:

Julio Gonzalez-Paoli, MD

Atlanta Research Center for Rheumatology

Recruiting

Marietta, Georgia, United States, 30060

Contacts

7703723962

Principal Investigator:

Roel Querubin

Satilla Rheumatology & Internal Medicine

Recruiting

Waycross, Georgia, United States, 31501

Contacts

9125480710

Principal Investigator:

CHARLES GALEA

Great Lakes Clinical Trials - Ravenswood

Recruiting

Chicago, Illinois, United States, 60640

Contacts

7732753500

Principal Investigator:

Manish Jain

Greater Chicago Specialty Physicians

Recruiting

Schaumburg, Illinois, United States, 60195

Contacts

8475992492

Principal Investigator:

Kamran Chaudhary

Arnold Arthritis & Rheumatology

Recruiting

Skokie, Illinois, United States, 60076

Principal Investigator:

Erin Arnold

Willow Rheumatology and Wellness PLLC

Recruiting

Willowbrook, Illinois, United States, 60527

Contacts

4349628466

Principal Investigator:

Angela Crowley

Lake Cumberland Rheumatology

Recruiting

New Albany, Indiana, United States, 47150

Contacts

5024953665

Principal Investigator:

Scott Lewis

Accurate Clinical Research, Inc

Recruiting

Lake Charles, Louisiana, United States, 70605

Contacts

337-312-8018

Principal Investigator:

Enrique Mendez

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

Recruiting

Cumberland, Maryland, United States, 21502

Contacts

301-724-4337

Principal Investigator:

Brandi Haas

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

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

301-791-6680

Principal Investigator:

Okechukwu Okoye

Clinical Research Institute of Michigan, LLC

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Principal Investigator:

Amar Majjhoo

Logan Health Rheumatology

Recruiting

Kalispell, Montana, United States, 59901

Contacts

406-752-2010

Principal Investigator:

Roger Diegel

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Norman Madsen

Onsite Clinical Solutions, LLC - Brenner Ave

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

800-785-3150

Principal Investigator:

Rakesh Patel

Paramount Medical Research & Consulting, LLC

Recruiting

Middleburg Heights, Ohio, United States, 44130

Contacts

440-826-0742

Principal Investigator:

Isam Diab

Essential Medical Research

Recruiting

Tulsa, Oklahoma, United States, 74137

Principal Investigator:

Debbie Gladd Foley

West Tennessee Research Institute

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

731-633-0145

Principal Investigator:

Jacob Aelion

AARA Clinical Research - Murfreesboro Medical Clinic

Recruiting

Murfreesboro, Tennessee, United States, 37128

Contacts

480-626-6650

Principal Investigator:

Marcus Owen

Precision Comprehensive Clinical Research Solutions - Colleyville

Recruiting

Colleyville, Texas, United States, 76034

Contacts

9722998399

Principal Investigator:

Dhiman Basu

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

Recruiting

Fort Worth, Texas, United States, 76109

Contacts

817-789-6770

Principal Investigator:

Himabindu Reddy

Accurate Clinical Research, Inc

Recruiting

Houston, Texas, United States, 77089

Contacts

281-481-8557

Principal Investigator:

Philip Waller

Research Physicians Network, LLC

Recruiting

Houston, Texas, United States, 77089

Contacts

281-944-3610

Principal Investigator:

Laila Hassan, MD

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

Recruiting

Irving, Texas, United States, 75039

Principal Investigator:

Shariq Chudhri,

Biopharma Informatic, LLC

Recruiting

Katy, Texas, United States, 77494

Contacts

(281) 944-3610

Principal Investigator:

Kiran Farheen, MD

Advanced Rheumatology of Houston - Woodlands

Recruiting

The Woodlands, Texas, United States, 77382

Contacts

936-681-4882

Principal Investigator:

Tamar Brionez

DM Clinical Research - TRA

Recruiting

Tomball, Texas, United States, 77375

Contacts

281-517-0550

Principal Investigator:

Shaikh Ali

Seattle Rheumatology Associates PLLC

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Philip Mease

Arthritis Northwest, PLLC

Recruiting

Spokane Valley, Washington, United States, 99216

Principal Investigator:

Sean LaSalle

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-06-11.