drugset / Trial / NCT06588283

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

Phase 3 Completed 281 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

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 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.

Timeline

Start: 2024-09-30
Primary completion: 2026-01-08
Completion: 2026-06-01

Outcome

Met primary endpoint

paper 27.1% of participants simultaneously achieved PASI 100 and a 10% or greater weight reduction with ixekizumab plus tirzepatide vs 5.8% with ixekizumab PMID 42139049 ↗

paper risk difference [RD], 21.2%; 95% CI, 12.8%-29.7%; P < .001 PMID 42139049 ↗

release “At 36 weeks in the TOGETHER-PsO study, concomitant Taltz and Zepbound met primary endpoint of superiority vs. Taltz monotherapy” lilly.com ↗

release “At 36 weeks in the TOGETHER-PsO study, concomitant Taltz and Zepbound met primary endpoint” lilly.com ↗

release “At the previously reported Week 36 primary endpoint, Taltz and Zepbound showed statistically superior improvements in disease activity and metabolic outcomes” lilly.com ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixekizumab	Monoclonal antibody	—	Subcutaneous
Subject	Tirzepatide	Peptide	—	Subcutaneous