TOGETHER-PsO

Active not recruitingPhase 3

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

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)

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

250

estimated

Study population

Obesity / overweight, Psoriasis / psoriatic arthritis

Key I/E criterion

•BMI ≥30

Primary endpoint

•Percentage of Participants Who Simultaneously Achieved Psoriasis Area (PASI 100 response, ≥10% weight-loss responders)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06588283

Org study ID27243

Secondary IDI1F-MC-RHDCEli Lilly and Company

Timeline

Milestones

Study first posted2024-09-19actual

Study start2024-09-30actual

Primary completion2026-01-08actual

Last update posted2026-01-20actual

Study completion2026-05estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightPsoriasis / psoriatic arthritis

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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).

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 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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percentage of Participants Achieving At Least 10% Weight Reduction

Time frame:Baseline to Week 36

≥10% weight-loss responders

threshold achievement, improvement

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

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

threshold achievement, improvement

componentsPASI 100 response, ≥10% weight-loss responders

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to Week 36

threshold achievement, improvement

components≥5% weight-loss responders, PASI75

Secondary/protocol endpoint

Percentage of Participants Achieving PASI 100

Time frame:Baseline to Week 36

threshold achievement, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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 May 15:e261753. doi: 10.1001/jamadermatol.2026.1753. Online ahead of print.
PMID42139049via clinicaltrials gov reference derived

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.