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PsoriasisPhase 3TOGETHER-PsONCT06588283

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

A Phase 3 study testing Ixekizumab and Tirzepatide in people with Psoriasis and Obesity, run by Eli Lilly and Company at 72 sites in 2 countries.

Completed

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

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis, 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
281 participants
Where
72 sitesin 2 countries
Study dates
30 Sep 2024to 1 Jun 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

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 13Show 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 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.

Trial locations and contacts

72 sites in 2 countries.

72 sites in 2 countries

United States68 sites

  • Care Access - Arlington

    Arlington, Virginia, 22206

  • Tekton Research - Westlake Drive

    Austin, Texas, 78746

  • DelRicht Research

    Baton Rouge, Louisiana, 70809

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401

  • Bellevue Dermatology Clinic

    Bellevue, Washington, 98004

  • Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

    Birmingham, Alabama, 35203

  • Optima Research - Boardman

    Boardman, Ohio, 44512

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky, 42104

  • Dermatology of Seattle

    Burien, Washington, 98168

  • The Derm Institute of West Michigan

    Caledonia, Michigan, 49316

  • DeNova Research

    Chicago, Illinois, 60602

  • Columbia Dermatology & Aesthetics

    Columbia, South Carolina, 29212

  • Life Clinical Trials

    Coral Springs, Florida, 33071

  • Modern Research Associates, PLLC

    Dallas, Texas, 75231

  • Care Access - Danville

    Danville, Virginia, 24541

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • Red River Research Partners

    Fargo, North Dakota, 58103

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

  • NeoClinical Research

    Hialeah, Florida, 33016

  • Care Access - Hoboken

    Hoboken, New Jersey, 07030

  • Skin Care Research

    Hollywood, Florida, 33021

  • Encore Medical Research

    Hollywood, Florida, 33024

  • Onsite Clinical Solutions - Huntersville

    Huntersville, North Carolina, 28078

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256

  • Avance Clinical Trials

    Laguna Niguel, California, 92677

  • Care Access - Lake Charles (Bayou Pines)

    Lake Charles, Louisiana, 70601

  • Las Vegas Dermatology

    Las Vegas, Nevada, 89144

  • Tanner Clinic

    Layton, Utah, 84041

  • Metropolis Dermatology

    Los Angeles, California, 90017

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Dermatologists of Southwest Ohio

    Mason, Ohio, 45040

  • Deluxe Health Center

    Miami Lakes, Florida, 33014

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee, 37130

  • Oak Dermatology

    Naperville, Illinois, 60563

  • Equity Medical

    New York, New York, 10023

  • Mount Sinai Doctors - East 85th Street

    New York, New York, 10028

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502

  • Northridge Clinical Trials

    Northridge, California, 91325

  • MI Skin Innovations

    Northville, Michigan, 48167

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Cura Clinical Research - Oxnard

    Oxnard, California, 93030

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

  • Leading Edge Dermatology

    Plantation, Florida, 33317

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462

  • Oregon Medical Research Center

    Portland, Oregon, 97201

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire, 03801

  • Skin Cancer and Dermatology Institute - Reno

    Reno, Nevada, 89509

  • Dermatology and Skin Cancer Specialists, LLC

    Rockville, Maryland, 20850

  • Lawrence J. Green, MD, LLC

    Rockville, Maryland, 20850

  • Integrative Skin Science and Research - Location 2

    Sacramento, California, 95815

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • Therapeutics Clinical Research

    San Diego, California, 92123

  • International Clinical Research - Sanford

    Sanford, Florida, 32771

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260

  • DelRicht Research - Thompson's Station

    Smyrna, Tennessee, 37167

  • Nodal Medical Center

    Tampa, Florida, 33607

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

    Tampa, Florida, 33609

  • Yuma Clinical Trials

    Yuma, Arizona, 85365

Other trials in United States

Puerto Rico4 sites

  • SCB Research Center

    Bayamón, 00961

  • Office of Dr. Alma M. Cruz

    Carolina, 00985

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

  • 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 Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsO)

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.

Conditions
Psoriasis, Obesity
Being tested
Ixekizumab, Tirzepatide
Medical subject headings
Psoriasis, 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 NCT06588283
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 Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction

    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI score compared to baseline.

    Measured: Baseline to Week 36

Secondary outcomes (3)

  1. Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction

    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately, and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

    Measured: Baseline to Week 36

  2. Percentage of Participants Achieving PASI 100

    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately, and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

    Measured: Baseline to Week 36

  3. Percentage of Participants Achieving At Least 10% Weight Reduction

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

    Measured: Baseline 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 start30 Sep 2024
  3. Primary completion8 Jan 2026
  4. Study completion1 Jun 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
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588283
Sponsor's protocol ID
27243
Other IDs
I1F-MC-RHDC
Acronym
TOGETHER-PsO
Status last verified
Jun 2026
First submitted
4 Sep 2024
Last updated
17 Jun 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

  • Lebwohl M, Blauvelt A, Kartman CE, Leatherwood C, Gordon KB, Sattar N, Puig L, Merola JF, Siu K, Wang R, Sun L, Leung A, Somani N, Rueda MJ, Cardoso A, Genovese MC, Armstrong AW, Strober B. Ixekizumab With or Without Tirzepatide in Adults With Psoriasis and Overweight or Obesity: A Phase 3b Randomized Clinical Trial. JAMA Dermatol. 2026 Jul 1;162(7):709-719. doi: 10.1001/jamadermatol.2026.1753.

    PubMed 42139049

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ixekizumab and Tirzepatide in people with Psoriasis and Obesity, run by Eli Lilly and Company at 72 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 4 inclusion and 13 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 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 Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction (time frame: Baseline 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 NCT06588283, 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 17 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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