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Trial · Interventional

CompletedPhase 3Registry data

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

Short name TOGETHER-PsA

NCTNCT06588296 (opens ClinicalTrials.gov in a new tab)Other id27241Other idI1F-MC-RHDB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
279 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

United States, Puerto Rico

Start
24 Sept 2024
Primary completion
18 Nov 2025
Completion
23 Apr 2026
First posted
19 Sept 2024
Last update posted
13 May 2026
Conditions
Psoriatic Arthritis · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 3

    TOGETHER-PsA

    NCT06588296

    24 Sept 2024 to 23 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • IxekizumabDrug
  • TirzepatideDrug

Arms2

  • Experimental

    Ixekizumab

    Ixekizumab administered subcutaneous (SC).

  • Experimental

    Ixekizumab and Tirzepatide

    Ixekizumab concomitantly administered with tirzepatide SC.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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)

Secondary outcomes(3)

  1. 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

    Registry description

    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)

  2. Percentage of Participants Achieving ACR50

    Time frame · Baseline up to Week 36

    Registry description

    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)

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

    Time frame · Baseline up to Week 36

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

9 results

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.

Merola et al. 2026Arthritis & rheumatology (Hoboken, N.J.)cited by 15

PMID 41903163PMC13619038DOI 10.1002/art.70134PUB-41903163

Free to read · publisher termsCC BY-NC9 results
Read at sourceSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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