Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

NCT ID: NCT06588283

Last Updated: 2026-01-20

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-05-31

Brief Summary

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The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab.

Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Detailed Description

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Conditions

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Psoriasis Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ixekizumab

Ixekizumab administered subcutaneous (SC).

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered SC

Ixekizumab and Tirzepatide

Ixekizumab concomitantly administered with tirzepatide SC.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered SC

Tirzepatide

Intervention Type DRUG

Administered SC.

Interventions

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Ixekizumab

Administered SC

Intervention Type DRUG

Tirzepatide

Administered SC.

Intervention Type DRUG

Other Intervention Names

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LY2439821 LY3298176

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months.
* Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12.
* Have ≥10% body surface area (BSA) involvement.
* Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to \<30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM).

Exclusion Criteria

Medical Conditions

* Have Type 1 Diabetes Mellitus (T1DM).
* Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
* Have a prior or planned surgical treatment for obesity.
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
* Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
* Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:

* basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
* cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
* Have serious disorder or illness other than PsO.
* Have a history of chronic or acute pancreatitis.
* Have any prior use of ixekizumab or tirzepatide.
* Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

Birmingham, Alabama, United States

Site Status

Medical Dermatology Specialists

Phoenix, Arizona, United States

Site Status

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Site Status

Yuma Clinical Trials

Yuma, Arizona, United States

Site Status

Johnson Dermatology

Fort Smith, Arkansas, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

First OC Dermatology Research Inc

Fountain Valley, California, United States

Site Status

Avance Clinical Trials

Laguna Niguel, California, United States

Site Status

Metropolis Dermatology

Los Angeles, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Northridge Clinical Trials

Northridge, California, United States

Site Status

Cura Clinical Research - Oxnard

Oxnard, California, United States

Site Status

Integrative Skin Science and Research - Location 2

Sacramento, California, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

Life Clinical Trials

Coral Springs, Florida, United States

Site Status

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, United States

Site Status

NeoClinical Research

Hialeah, Florida, United States

Site Status

Skin Care Research

Hollywood, Florida, United States

Site Status

Encore Medical Research

Hollywood, Florida, United States

Site Status

Solutions Through Advanced Research

Jacksonville, Florida, United States

Site Status

Deluxe Health Center

Miami Lakes, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Leading Edge Dermatology

Plantation, Florida, United States

Site Status

International Clinical Research - Sanford

Sanford, Florida, United States

Site Status

Nodal Medical Center

Tampa, Florida, United States

Site Status

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

Tampa, Florida, United States

Site Status

DeNova Research

Chicago, Illinois, United States

Site Status

Oak Dermatology

Naperville, Illinois, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Site Status

Equity Medical - Bowling Green

Bowling Green, Kentucky, United States

Site Status

DelRicht Research

Baton Rouge, Louisiana, United States

Site Status

Care Access - Lake Charles (Bayou Pines)

Lake Charles, Louisiana, United States

Site Status

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, United States

Site Status

Lawrence J. Green, MD, LLC

Rockville, Maryland, United States

Site Status

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Site Status

The Derm Institute of West Michigan

Caledonia, Michigan, United States

Site Status

MI Skin Innovations

Northville, Michigan, United States

Site Status

Las Vegas Dermatology

Las Vegas, Nevada, United States

Site Status

Skin Cancer and Dermatology Institute - Reno

Reno, Nevada, United States

Site Status

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, United States

Site Status

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Site Status

Care Access - Hoboken

Hoboken, New Jersey, United States

Site Status

Equity Medical

New York, New York, United States

Site Status

Mount Sinai Doctors - East 85th Street

New York, New York, United States

Site Status

Onsite Clinical Solutions - Huntersville

Huntersville, North Carolina, United States

Site Status

Red River Research Partners

Fargo, North Dakota, United States

Site Status

Optima Research - Boardman

Boardman, Ohio, United States

Site Status

Dermatologists of Southwest Ohio

Mason, Ohio, United States

Site Status

Oregon Medical Research Center

Portland, Oregon, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States

Site Status

Columbia Dermatology & Aesthetics

Columbia, South Carolina, United States

Site Status

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, United States

Site Status

DelRicht Research - Thompson's Station

Smyrna, Tennessee, United States

Site Status

Tekton Research - Westlake Drive

Austin, Texas, United States

Site Status

Bellaire Dermatology Associates

Bellaire, Texas, United States

Site Status

Modern Research Associates, PLLC

Dallas, Texas, United States

Site Status

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Care Access - Arlington

Arlington, Virginia, United States

Site Status

Care Access - Danville

Danville, Virginia, United States

Site Status

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Site Status

Bellevue Dermatology Clinic

Bellevue, Washington, United States

Site Status

Dermatology of Seattle

Burien, Washington, United States

Site Status

SCB Research Center

Bayamón, , Puerto Rico

Site Status

Office of Dr. Alma M. Cruz

Carolina, , Puerto Rico

Site Status

GCM Medical Group, PSC - Hato Rey Site

San Juan, , Puerto Rico

Site Status

Mindful Medical Research

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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I1F-MC-RHDC

Identifier Type: OTHER

Identifier Source: secondary_id

27243

Identifier Type: -

Identifier Source: org_study_id

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