Recruiting

Tirzepatide & IxekizumabA 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)

Sponsor:

Eli Lilly and Company

Code:

NCT06857942

Conditions

Psoriasis

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 moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.

Conditions

Psoriasis

Overweight or Obesity

Study ID

NCT06857942

Start date

Mar 19, 2025

Status verified date

Sep, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

Participants will continue to receive ixekizumab and take tirzepatide subcutaneously (SC) as per label.

Interventions

Tirzepatide

Administered SC

Primary outcome measure

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) [ Time Frame: 12 months ]
Percentage of Participants Achieving at least 10% Weight Reduction [ 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

Medical Dermatology Specialists

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

602-354-5770

Principal Investigator:

Lindsay Ackerman

First OC Dermatology Research Inc

Recruiting

Fountain Valley, California, United States, 92708

Contacts

714-531-2966

Principal Investigator:

Vivian Laquer

Center For Dermatology Clinical Research, Inc.

Recruiting

Fremont, California, United States, 94538

Contacts

510-797-0140

Principal Investigator:

Sunil Dhawan

Metropolis Dermatology

Recruiting

Los Angeles, California, United States, 90017

Contacts

424-393-0005

Principal Investigator:

Yen (James) Wang

Northridge Clinical Trials

Recruiting

Northridge, California, United States, 91325

Contacts

818-350-7482

Principal Investigator:

Navid Ezra

NeoClinical Research

Recruiting

Hialeah, Florida, United States, 33016

Contacts

305-456-9062

Principal Investigator:

Martin Zaiac, MD

Skin Care Research

Recruiting

Hollywood, Florida, United States, 33021

Contacts

954-674-3535

Principal Investigator:

Eduardo Weiss

Encore Medical Research

Recruiting

Hollywood, Florida, United States, 33024

Contacts

954-400-1725

Principal Investigator:

Jerome Obed

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

Recruiting

Tampa, Florida, United States, 33607

Contacts

813-948-7550

Principal Investigator:

Stephen Lockwood

TruDerm & TruSpa

Recruiting

Wellington, Florida, United States, 33449

Principal Investigator:

Andleeb Usmani

Southeast Research Specialists

Recruiting

Douglasville, Georgia, United States, 30135

Contacts

678-702-3376

Principal Investigator:

Firas George Hougeir

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

317-516-5030

Principal Investigator:

Scott Fretzin

The Indiana Clinical Trials Center, PC

Recruiting

Plainfield, Indiana, United States, 46168

Contacts

317-837-6082

Principal Investigator:

Scott Guenthner

Equity Medical - Bowling Green

Recruiting

Bowling Green, Kentucky, United States, 42104

Contacts

270-213-7777

Principal Investigator:

James Allred

Dermatology and Skin Cancer Specialists, LLC

Recruiting

Rockville, Maryland, United States, 20850

Principal Investigator:

Benjamin Lockshin

Metro Boston Clinical Partners

Recruiting

Brighton, Massachusetts, United States, 02135

Principal Investigator:

Mark Amster

David Fivenson, MD, PLC

Recruiting

Ann Arbor, Michigan, United States, 48103

Contacts

734-222-9630

Principal Investigator:

David Fivenson

The Derm Institute of West Michigan

Recruiting

Caledonia, Michigan, United States, 49316

Contacts

616-326-0114

Principal Investigator:

Kristi Hawley

Skin Cancer and Dermatology Institute - Reno

Recruiting

Reno, Nevada, United States, 89509

Contacts

775-336-3658

Principal Investigator:

Michael Heaphy

Stracskin

Recruiting

Portsmouth, New Hampshire, United States, 03801

Contacts

617-833-9995

Principal Investigator:

Abel Jarell

Psoriasis Treatment Center of Central New Jersey

Recruiting

East Windsor, New Jersey, United States, 08520

Principal Investigator:

Alexa Hetzel

Care Access - Hoboken

Recruiting

Hoboken, New Jersey, United States, 07030

Contacts

551-278-8680

Principal Investigator:

Adolfo Fernandez- Obregon

Equity Medical

Recruiting

New York, New York, United States, 10023

Contacts

212-466-6550

Principal Investigator:

Michael Cameron

Revival Research Institute, LLC

Recruiting

Cary, North Carolina, United States, 27511

Principal Investigator:

Zain Husain

Onsite Clinical Solutions - Huntersville

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

800-785-3150

Principal Investigator:

Nicole Seminara-Zambrzycka

Optima Research - Boardman

Recruiting

Boardman, Ohio, United States, 44512

Contacts

330-422-3234

Principal Investigator:

Patrick Shannon

Oregon Dermatology and Research Center

Recruiting

Portland, Oregon, United States, 97210

Contacts

503-226-3376

Principal Investigator:

Phoebe Rich, MD

Dermatology Associates of Plymouth Meeting

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Principal Investigator:

Jonathan Wolfe

Columbia Dermatology & Aesthetics

Recruiting

Columbia, South Carolina, United States, 29212

Contacts

803-731-9600

Principal Investigator:

Jessica Burgy

DelRicht Research - Thompson's Station

Recruiting

Smyrna, Tennessee, United States, 37167

Contacts

629-895-1775

Principal Investigator:

Pezhman Shoureshi

Bellaire Dermatology Associates

Recruiting

Bellaire, Texas, United States, 77401

Contacts

713-661-4383

Principal Investigator:

Craig Teller

Modern Research Associates, PLLC

Recruiting

Dallas, Texas, United States, 75231

Contacts

214-361-2008

Principal Investigator:

Jennifer Cather

Center for Clinical Studies

Recruiting

Houston, Texas, United States, 77004

Contacts

713-528-8818

Principal Investigator:

Stephen Tyring

Austin Institute for Clinical Research

Recruiting

Pflugerville, Texas, United States, 78660

Contacts

512-279-2545

Principal Investigator:

Edward Lain

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Contacts

210-852-2779

Principal Investigator:

John Browning

Center for Clinical Studies

Recruiting

Webster, Texas, United States, 77598

Contacts

281-333-2288

Principal Investigator:

PATRICIA LEE

Tanner Clinic

Recruiting

Layton, Utah, United States, 84041

Principal Investigator:

Scott Checketts

Bellevue Dermatology Clinic

Recruiting

Bellevue, Washington, United States, 98104

Contacts

425-455-2275

Principal Investigator:

Clive Liu

Dermatology of Seattle

Recruiting

Burien, Washington, United States, 98168

Contacts

206-248-5020

Principal Investigator:

Elie Levy

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.