Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

NCT ID: NCT06588296

Last Updated: 2026-01-21

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

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2026-04-30

Brief Summary

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The main purpose of this study is to demonstrate that when participants with psoriatic arthritis 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 psoriatic arthritis 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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Psoriatic Arthritis 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 signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and currently fulfilling the classification of Psoriatic Arthritis (CASPAR) criteria.
* Have active PsA, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints.
* 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 a serious disorder or illness other than PsA.
* Have a history of chronic or acute pancreatitis.
* Have any prior use of ixekizumab or tirzepatide.
* Diagnosis of other inflammatory arthritis, such as Rheumatoid Arthritis (RA), ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis.
* 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

Maximum Eligible Age

80 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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AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States

Site Status

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, United States

Site Status

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, United States

Site Status

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, United States

Site Status

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, United States

Site Status

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, United States

Site Status

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

Phoenix, Arizona, United States

Site Status

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

Sun City, Arizona, United States

Site Status

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona, United States

Site Status

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

Tucson, Arizona, United States

Site Status

Medvin Clinical Research - Apple Valley

Apple Valley, California, United States

Site Status

Medvin Clinical Research - Covina

Covina, California, United States

Site Status

Newport Huntington Medical Group

Huntington Beach, California, United States

Site Status

Purushotham & Akther Kotha MD, Inc

La Mesa, California, United States

Site Status

Medvin Clinical Research - Riverside

Riverside, California, United States

Site Status

Rheumatology Center of San Diego

San Diego, California, United States

Site Status

Medvin Clinical Research - Temecula

Temecula, California, United States

Site Status

Cohen Medical Centers

Thousand Oaks, California, United States

Site Status

Medvin Clinical Research - Tujunga

Tujunga, California, United States

Site Status

Medvin Clinical Research - Whittier

Whittier, California, United States

Site Status

Denver Arthritis Clinic

Denver, Colorado, United States

Site Status

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, United States

Site Status

NeoClinical Research

Hialeah, Florida, United States

Site Status

South Florida Rheumatology

Hollywood, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Vida Clinical Research

Kissimmee, Florida, United States

Site Status

Life Clinical Trials

Margate, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Vitalia Medical Research

Palm Beach Gardens, Florida, United States

Site Status

Sarasota Arthritis Center

Sarasota, Florida, United States

Site Status

Clinical Research of West Florida

Tampa, Florida, United States

Site Status

International Center for Research

Tampa, Florida, United States

Site Status

Conquest Research

Winter Park, Florida, United States

Site Status

Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia

Gainesville, Georgia, United States

Site Status

Atlanta Research Center for Rheumatology

Marietta, Georgia, United States

Site Status

St. Luke's Clinic

Boise, Idaho, United States

Site Status

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status

Greater Chicago Specialty Physicians

Schaumburg, Illinois, United States

Site Status

Arnold Arthritis & Rheumatology

Skokie, Illinois, United States

Site Status

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States

Site Status

Qualmedica Research, LLC

Evansville, Indiana, United States

Site Status

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Site Status

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States

Site Status

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

Cumberland, Maryland, United States

Site Status

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

Hagerstown, Maryland, United States

Site Status

NECCR PrimaCare Research

Fall River, Massachusetts, United States

Site Status

Advanced Rheumatology, PC

Okemos, Michigan, United States

Site Status

Saint Paul Rheumatology

Eagan, Minnesota, United States

Site Status

AARA Clinical Research - Kansas City Physician Partners - North

Kansas City, Missouri, United States

Site Status

Clinvest Headlands Llc

Springfield, Missouri, United States

Site Status

Arthritis Consultants, Inc.

St Louis, Missouri, United States

Site Status

Logan Health Research

Kalispell, Montana, United States

Site Status

Physician Research Collaboration, LLC

Lincoln, Nebraska, United States

Site Status

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, United States

Site Status

Inspire Santa Fe Medical Group

Santa Fe, New Mexico, United States

Site Status

St. Lawrence Health System

Canton, New York, United States

Site Status

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury, North Carolina, United States

Site Status

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Site Status

RAO Research LLC

Oklahoma City, Oklahoma, United States

Site Status

Essential Medical Research

Tulsa, Oklahoma, United States

Site Status

Summit Headlands

Portland, Oregon, United States

Site Status

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee, United States

Site Status

Tekton Research, LLC.

Austin, Texas, United States

Site Status

Accurate Clinical Management, LLC

Baytown, Texas, United States

Site Status

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville, Texas, United States

Site Status

Arthritis Care of Texas

Corpus Christi, Texas, United States

Site Status

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

Fort Worth, Texas, United States

Site Status

Accurate Clinical Research, Inc

Houston, Texas, United States

Site Status

Research Physicians Network, LLC

Houston, Texas, United States

Site Status

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

Irving, Texas, United States

Site Status

Biopharma Informatic, LLC

Katy, Texas, United States

Site Status

West Texas Clinical Research

Lubbock, Texas, United States

Site Status

Valley Arthritis Center

McAllen, Texas, United States

Site Status

SouthWest Rheumatology Research, LLC

Mesquite, Texas, United States

Site Status

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, United States

Site Status

DM Clinical Research - TRA

Tomball, Texas, United States

Site Status

Overlake Arthritis and Osteoporosis Center

Bellevue, Washington, United States

Site Status

Arthritis Northwest, PLLC

Spokane, Washington, United States

Site Status

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, United States

Site Status

Centro Reumatologico Caguas

Caguas, , Puerto Rico

Site Status

Reuviva Research Center

Guaynabo, , Puerto Rico

Site Status

GCM Medical Group, PSC - Hato Rey Site

San Juan, , Puerto Rico

Site Status

Caribbean Medical Research Center

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-RHDB

Identifier Type: OTHER

Identifier Source: secondary_id

27241

Identifier Type: -

Identifier Source: org_study_id

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