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Psoriatic ArthritisPhase 3TOGETHER-PsANCT06588296

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

A Phase 3 study testing Ixekizumab and Tirzepatide in people with Psoriatic Arthritis and Obesity, run by Eli Lilly and Company at 86 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Psoriatic Arthritis, Obesity
What is being tested?
Ixekizumab and Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
86 sitesin 2 countries
Study dates
24 Sep 2024to 23 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

86 sites in 2 countries.

86 sites in 2 countries

United States81 sites

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102

  • Medvin Clinical Research - Apple Valley

    Apple Valley, California, 92307

  • Tekton Research, LLC.

    Austin, Texas, 78745

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

    Avondale, Arizona, 85392

  • Accurate Clinical Management, LLC

    Baytown, Texas, 77521

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia, 25801

  • Overlake Arthritis and Osteoporosis Center

    Bellevue, Washington, 98004

  • St. Luke's Clinic

    Boise, Idaho, 83702

  • St. Lawrence Health System

    Canton, New York, 13617

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

    Chandler, Arizona, 85225

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • Precision Comprehensive Clinical Research Solutions - Colleyville

    Colleyville, Texas, 76034

  • Arthritis Care of Texas

    Corpus Christi, Texas, 78415

  • Medvin Clinical Research - Covina

    Covina, California, 91722

  • Klein & Associates, M.D., P.A.

    Cumberland, Maryland, 21502

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Saint Paul Rheumatology

    Eagan, Minnesota, 55121

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

    Flagstaff, Arizona, 86001

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

    Fort Worth, Texas, 76109

  • Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

    Gilbert, Arizona, 85297

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

    Glendale, Arizona, 85306

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland, 21740

  • NeoClinical Research

    Hialeah, Florida, 33016

  • South Florida Rheumatology

    Hollywood, Florida, 33021

  • Accurate Clinical Research, Inc

    Houston, Texas, 77089

  • Research Physicians Network, LLC

    Houston, Texas, 77089

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648

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

    Irving, Texas, 75039

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Logan Health Research

    Kalispell, Montana, 59901

  • AARA Clinical Research - Kansas City Physician Partners - North

    Kansas City, Missouri, 64151

  • Biopharma Informatic, LLC

    Katy, Texas, 77494

  • Vida Clinical Research

    Kissimmee, Florida, 34741

  • Purushotham & Akther Kotha MD, Inc

    La Mesa, California, 91942

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana, 70605

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • West Texas Clinical Research

    Lubbock, Texas, 79424

  • Life Clinical Trials

    Margate, Florida, 33063

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060

  • Valley Arthritis Center

    McAllen, Texas, 78501

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

    Mesa, Arizona, 85210

  • SouthWest Rheumatology Research, LLC

    Mesquite, Texas, 75150

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • AARA Clinical Research - Murfreesboro Medical Clinic

    Murfreesboro, Tennessee, 37128

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Advanced Rheumatology, PC

    Okemos, Michigan, 48864

  • RAO Research LLC

    Oklahoma City, Oklahoma, 73116

  • Vitalia Medical Research

    Palm Beach Gardens, Florida, 33410

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

    Phoenix, Arizona, 85032

  • Summit Headlands

    Portland, Oregon, 97210

  • Medvin Clinical Research - Riverside

    Riverside, California, 92508

  • Onsite Clinical Solutions, LLC - Brenner Ave

    Salisbury, North Carolina, 28144

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • Inspire Santa Fe Medical Group

    Santa Fe, New Mexico, 87505

  • Sarasota Arthritis Center

    Sarasota, Florida, 34239

  • Greater Chicago Specialty Physicians

    Schaumburg, Illinois, 60195

  • Arnold Arthritis & Rheumatology

    Skokie, Illinois, 60076

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • Clinvest Headlands Llc

    Springfield, Missouri, 65807

  • Arthritis Consultants, Inc.

    St Louis, Missouri, 63141

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

    Sun City, Arizona, 85351

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • International Center for Research

    Tampa, Florida, 33614

  • Medvin Clinical Research - Temecula

    Temecula, California, 92592

  • Advanced Rheumatology of Houston - Woodlands

    The Woodlands, Texas, 77382

  • Cohen Medical Centers

    Thousand Oaks, California, 91360

  • DM Clinical Research - TRA

    Tomball, Texas, 77375

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

    Tucson, Arizona, 85704

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

    Tucson, Arizona, 85748

  • Medvin Clinical Research - Tujunga

    Tujunga, California, 91042

  • Essential Medical Research

    Tulsa, Oklahoma, 74137

  • Medvin Clinical Research - Whittier

    Whittier, California, 90602

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Puerto Rico5 sites

  • Centro Reumatologico Caguas

    Caguas, 00725

  • Reuviva Research Center

    Guaynabo, 00968

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

  • Caribbean Medical Research Center

    San Juan, 00918

  • Mindful Medical Research

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Ixekizumab, Tirzepatide
Medical subject headings
Arthritis, Psoriatic, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxekizumabDrug

    Also called LY2439821

    Administered SC

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

Study groups in NCT06588296
Study groupRoleWhat they receive
IxekizumabExperimentalIxekizumab administered subcutaneous (SC).
Receives: Drug: Ixekizumab
Ixekizumab and TirzepatideExperimentalIxekizumab concomitantly administered with tirzepatide SC.
Receives: Drug: Ixekizumab; Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction

    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)

    Measured: Baseline up to Week 36

Secondary outcomes (3)

  1. Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction

    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)

    Measured: Baseline up to Week 36

  2. Percentage of Participants Achieving ACR50

    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)

    Measured: Baseline up to Week 36

  3. Percentage of Participants Achieving at Least a 10% Weight Reduction

    Percentage of Participants Who Achieved at Least a 10% Weight Reduction

    Measured: Baseline up to Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start24 Sep 2024
  3. Primary completion18 Nov 2025
  4. Study completion23 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588296
Sponsor's protocol ID
27241
Other IDs
I1F-MC-RHDB
Acronym
TOGETHER-PsA
Status last verified
May 2026
First submitted
4 Sep 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Merola JF, Mease P, Kivitz A, Sattar N, Coates LC, Aletaha D, Kartman CE, Fischer P, Sun L, Martinez-Osuna P, Kronbergs A, Prajapati P, Cardoso A, Genovese MC, Ogdie A. Ixekizumab With Tirzepatide Achieved Greater Disease Control Than Ixekizumab Alone in Adults With Psoriatic Arthritis and Overweight or Obesity: Results From a Randomized Clinical Trial. Arthritis Rheumatol. 2026 Mar 28. doi: 10.1002/art.70134. Online ahead of print.

    PubMed 41903163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ixekizumab and Tirzepatide in people with Psoriatic Arthritis and Obesity, run by Eli Lilly and Company at 86 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06588296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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