Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight (TOGETHER-PsA)

May 12, 2026 updated by: Eli Lilly and Company

Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Centro Reumatologico Caguas
      • Guaynabo, Puerto Rico, 00968
        • Reuviva Research Center
      • San Juan, Puerto Rico, 00918
        • Mindful Medical Research
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
      • San Juan, Puerto Rico, 00918
        • Caribbean Medical Research Center
  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
      • Chandler, Arizona, United States, 85225
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
      • Flagstaff, Arizona, United States, 86001
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
      • Gilbert, Arizona, United States, 85297
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
      • Glendale, Arizona, United States, 85306
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
      • Mesa, Arizona, United States, 85210
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
      • Phoenix, Arizona, United States, 85032
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
      • Sun City, Arizona, United States, 85351
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
      • Tucson, Arizona, United States, 85748
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
      • Tucson, Arizona, United States, 85704
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
    • California
      • Apple Valley, California, United States, 92307
        • Medvin Clinical Research - Apple Valley
      • Covina, California, United States, 91722
        • Medvin Clinical Research - Covina
      • Huntington Beach, California, United States, 92648
        • Newport Huntington Medical Group
      • La Mesa, California, United States, 91942
        • Purushotham & Akther Kotha MD, Inc
      • Riverside, California, United States, 92508
        • Medvin Clinical Research - Riverside
      • San Diego, California, United States, 92128
        • Rheumatology Center of San Diego
      • Temecula, California, United States, 92592
        • Medvin Clinical Research - Temecula
      • Thousand Oaks, California, United States, 91360
        • Cohen Medical Centers
      • Tujunga, California, United States, 91042
        • Medvin Clinical Research - Tujunga
      • Whittier, California, United States, 90602
        • Medvin Clinical Research - Whittier
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc. (Clearwater)
      • Hialeah, Florida, United States, 33016
        • Neoclinical Research
      • Hollywood, Florida, United States, 33021
        • South Florida Rheumatology
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Kissimmee, Florida, United States, 34741
        • Vida Clinical Research
      • Margate, Florida, United States, 33063
        • Life Clinical Trials
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Palm Beach Gardens, Florida, United States, 33410
        • Vitalia Medical Research
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Center
      • Tampa, Florida, United States, 33606
        • Clinical Research of West Florida
      • Tampa, Florida, United States, 33614
        • International Center for Research
      • Winter Park, Florida, United States, 32789
        • Conquest Research
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
      • Marietta, Georgia, United States, 30060
        • Atlanta Research Center for Rheumatology
    • Idaho
      • Boise, Idaho, United States, 83702
        • St. Luke's Clinic
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials - Ravenswood
      • Schaumburg, Illinois, United States, 60195
        • Greater Chicago Specialty Physicians
      • Skokie, Illinois, United States, 60076
        • Arnold Arthritis & Rheumatology
      • Willowbrook, Illinois, United States, 60527
        • Willow Rheumatology and Wellness PLLC
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Accurate Clinical Research, Inc
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Klein & Associates, M.D., P.A.
      • Hagerstown, Maryland, United States, 21740
        • Klein & Associates, M.D., P.A.
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research
    • Michigan
      • Okemos, Michigan, United States, 48864
        • Advanced Rheumatology, PC
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Saint Paul Rheumatology
    • Missouri
      • Kansas City, Missouri, United States, 64151
        • AARA Clinical Research - Kansas City Physician Partners - North
      • Springfield, Missouri, United States, 65807
        • Clinvest Headlands LLC
      • St Louis, Missouri, United States, 63141
        • Arthritis Consultants, Inc.
    • Montana
      • Kalispell, Montana, United States, 59901
        • Logan Health Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Center for Rheumatology
      • Santa Fe, New Mexico, United States, 87505
        • Inspire Santa Fe Medical Group
    • New York
      • Canton, New York, United States, 13617
        • St. Lawrence Health System
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Onsite Clinical Solutions, LLC - Brenner Ave
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • RAO Research LLC
      • Tulsa, Oklahoma, United States, 74137
        • Essential Medical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Headlands
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute
      • Murfreesboro, Tennessee, United States, 37128
        • AARA Clinical Research - Murfreesboro Medical Clinic
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, LLC.
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Management, LLC
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions - Colleyville
      • Corpus Christi, Texas, United States, 78415
        • Arthritis Care of Texas
      • Fort Worth, Texas, United States, 76109
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
      • Houston, Texas, United States, 77089
        • Research Physicians Network, LLC
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research, Inc
      • Irving, Texas, United States, 75039
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
      • Katy, Texas, United States, 77494
        • Biopharma Informatic, LLC
      • Lubbock, Texas, United States, 79424
        • West Texas Clinical Research
      • McAllen, Texas, United States, 78501
        • Valley Arthritis Center
      • Mesquite, Texas, United States, 75150
        • SouthWest Rheumatology Research, LLC
      • The Woodlands, Texas, United States, 77382
        • Advanced Rheumatology of Houston - Woodlands
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - TRA
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Arthritis and Osteoporosis Center
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology & Pulmonary Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ixekizumab
Ixekizumab administered subcutaneous (SC).
Drug: Ixekizumab
Administered SC
Other Names:
  • LY2439821
Experimental: Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
Drug: Ixekizumab
Administered SC
Other Names:
  • LY2439821
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
Time Frame: Baseline up to Week 36

ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments:

  1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
  2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
  3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
  4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
  5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
Baseline up to Week 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction
Time Frame: Baseline up to Week 36

ACR20 is defined as at least 20% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 20% in the number of TJC (0-68) and SJC (0-66) and an improvement of at least 20% in at least 3 of these 5 assessments:

  1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
  2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
  3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
  4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
  5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
Baseline up to Week 36
Percentage of Participants Achieving ACR50
Time Frame: Baseline up to Week 36

ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of TJC (0-68) and SJC (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments:

  1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
  2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
  3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
  4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
  5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
Baseline up to Week 36
Percentage of Participants Achieving at Least a 10% Weight Reduction
Time Frame: Baseline up to Week 36
Percentage of Participants Who Achieved at Least a 10% Weight Reduction
Baseline up to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Actual)

November 18, 2025

Study Completion (Actual)

April 23, 2026

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27241
  • I1F-MC-RHDB (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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