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)

NCT ID: NCT06864026

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Arthritis Overweight or Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tirzepatide

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

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States

Site Status RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, United States

Site Status RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, United States

Site Status RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, United States

Site Status RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, United States

Site Status RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, United States

Site Status RECRUITING

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

Phoenix, Arizona, United States

Site Status RECRUITING

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

Sun City, Arizona, United States

Site Status RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona, United States

Site Status RECRUITING

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

Tucson, Arizona, United States

Site Status RECRUITING

Medvin Clinical Research - Apple Valley

Apple Valley, California, United States

Site Status RECRUITING

Medvin Clinical Research - Covina

Covina, California, United States

Site Status RECRUITING

Newport Huntington Medical Group

Huntington Beach, California, United States

Site Status RECRUITING

Purushotham & Akther Kotha MD, Inc

La Mesa, California, United States

Site Status RECRUITING

Medvin Clinical Research - Riverside

Riverside, California, United States

Site Status RECRUITING

Rheumatology Center of San Diego

San Diego, California, United States

Site Status RECRUITING

Providence Saint John's Medical Foundation

Santa Monica, California, United States

Site Status RECRUITING

Medvin Clinical Research - Temecula

Temecula, California, United States

Site Status RECRUITING

Medvin Clinical Research - Tujunga

Tujunga, California, United States

Site Status RECRUITING

Medvin Clinical Research - Whittier

Whittier, California, United States

Site Status RECRUITING

Vida Clinical Research

Kissimmee, Florida, United States

Site Status RECRUITING

Life Clinical Trials

Margate, Florida, United States

Site Status RECRUITING

CZ Rheumatology

Miami Beach, Florida, United States

Site Status RECRUITING

Vitalia Medical Research

Palm Beach Gardens, Florida, United States

Site Status RECRUITING

International Center for Research

Tampa, Florida, United States

Site Status RECRUITING

Atlanta Research Center for Rheumatology

Marietta, Georgia, United States

Site Status RECRUITING

Satilla Rheumatology & Internal Medicine

Waycross, Georgia, United States

Site Status RECRUITING

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status RECRUITING

Greater Chicago Specialty Physicians

Schaumburg, Illinois, United States

Site Status RECRUITING

Arnold Arthritis & Rheumatology

Skokie, Illinois, United States

Site Status RECRUITING

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States

Site Status RECRUITING

Lake Cumberland Rheumatology

New Albany, Indiana, United States

Site Status RECRUITING

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States

Site Status RECRUITING

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

Cumberland, Maryland, United States

Site Status RECRUITING

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

Hagerstown, Maryland, United States

Site Status RECRUITING

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States

Site Status RECRUITING

Logan Health Rheumatology

Kalispell, Montana, United States

Site Status RECRUITING

University of Rochester Medical Center

Rochester, New York, United States

Site Status RECRUITING

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury, North Carolina, United States

Site Status RECRUITING

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Site Status RECRUITING

Essential Medical Research

Tulsa, Oklahoma, United States

Site Status RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status RECRUITING

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee, United States

Site Status RECRUITING

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville, Texas, United States

Site Status RECRUITING

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

Fort Worth, Texas, United States

Site Status RECRUITING

Accurate Clinical Research, Inc

Houston, Texas, United States

Site Status RECRUITING

Research Physicians Network, LLC

Houston, Texas, United States

Site Status RECRUITING

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

Irving, Texas, United States

Site Status RECRUITING

Biopharma Informatic, LLC

Katy, Texas, United States

Site Status RECRUITING

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, United States

Site Status RECRUITING

DM Clinical Research - TRA

Tomball, Texas, United States

Site Status RECRUITING

Seattle Rheumatology Associates PLLC

Seattle, Washington, United States

Site Status RECRUITING

Arthritis Northwest, PLLC

Spokane Valley, Washington, United States

Site Status RECRUITING

Reuviva Research Center

Guaynabo, , Puerto Rico

Site Status RECRUITING

Caribbean Medical Research Center

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

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United States Puerto Rico

Central Contacts

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

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Related Links

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Other Identifiers

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I1F-MC-RHDE

Identifier Type: OTHER

Identifier Source: secondary_id

27350

Identifier Type: -

Identifier Source: org_study_id