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)

NCT ID: NCT06857942

Last Updated: 2025-11-06

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

2025-03-19

Study Completion Date

2026-10-31

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 plaque PsO 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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Psoriasis 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 to receive ixekizumab and take tirzepatide 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 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.
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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Medical Dermatology Specialists

Phoenix, Arizona, United States

Site Status RECRUITING

First OC Dermatology Research Inc

Fountain Valley, California, United States

Site Status RECRUITING

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status RECRUITING

Metropolis Dermatology

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Northridge Clinical Trials

Northridge, California, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, United States

Site Status RECRUITING

NeoClinical Research

Hialeah, Florida, United States

Site Status RECRUITING

Skin Care Research

Hollywood, Florida, United States

Site Status RECRUITING

Encore Medical Research

Hollywood, Florida, United States

Site Status RECRUITING

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

Tampa, Florida, United States

Site Status RECRUITING

TruDerm & TruSpa

Wellington, Florida, United States

Site Status RECRUITING

Southeast Research Specialists

Douglasville, Georgia, United States

Site Status RECRUITING

Arlington Dermatology

Rolling Meadows, Illinois, United States

Site Status RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status RECRUITING

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Site Status RECRUITING

Equity Medical - Bowling Green

Bowling Green, Kentucky, United States

Site Status RECRUITING

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States

Site Status RECRUITING

Metro Boston Clinical Partners

Brighton, Massachusetts, United States

Site Status RECRUITING

David Fivenson, MD, PLC

Ann Arbor, Michigan, United States

Site Status RECRUITING

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Site Status RECRUITING

The Derm Institute of West Michigan

Caledonia, Michigan, United States

Site Status RECRUITING

Skin Cancer and Dermatology Institute - Reno

Reno, Nevada, United States

Site Status RECRUITING

Stracskin

Portsmouth, New Hampshire, United States

Site Status RECRUITING

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Site Status RECRUITING

Care Access - Hoboken

Hoboken, New Jersey, United States

Site Status RECRUITING

Equity Medical

New York, New York, United States

Site Status RECRUITING

Revival Research Institute, LLC

Cary, North Carolina, United States

Site Status RECRUITING

Onsite Clinical Solutions - Huntersville

Huntersville, North Carolina, United States

Site Status RECRUITING

Optima Research - Boardman

Boardman, Ohio, United States

Site Status RECRUITING

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status RECRUITING

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States

Site Status RECRUITING

Columbia Dermatology & Aesthetics

Columbia, South Carolina, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Myrtle Beach, South Carolina, United States

Site Status RECRUITING

DelRicht Research - Thompson's Station

Smyrna, Tennessee, United States

Site Status RECRUITING

Bellaire Dermatology Associates

Bellaire, Texas, United States

Site Status RECRUITING

Modern Research Associates, PLLC

Dallas, Texas, United States

Site Status RECRUITING

Center for Clinical Studies

Houston, Texas, United States

Site Status RECRUITING

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Site Status RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status RECRUITING

Center for Clinical Studies

Webster, Texas, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Layton, Utah, United States

Site Status RECRUITING

Tanner Clinic

Layton, Utah, United States

Site Status RECRUITING

Bellevue Dermatology Clinic

Bellevue, Washington, United States

Site Status RECRUITING

Dermatology of Seattle

Burien, Washington, United States

Site Status RECRUITING

Office of Dr. Alma M. Cruz

Carolina, , 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-RHDD

Identifier Type: OTHER

Identifier Source: secondary_id

27319

Identifier Type: -

Identifier Source: org_study_id