drugset / Trial / NCT06588296

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

NCT06588296 ↗

Phase 3 Completed 279 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

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 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
2024-09-24
Primary completion
2025-11-18
Completion
2026-04-23

Outcome

Met primary endpoint

paper The primary end point was achieved with significant improvements in the IXE + TZP arm (31.7%) compared to IXE alone (0.8%) (P < 0.001). PMID 41903163 ↗

release “At 36 weeks, the TOGETHER-PsA study met its primary endpoint of 50% improvement in psoriatic arthritis (PsA) activity” lilly.com ↗

release “Taltz and Zepbound used together provided comprehensive improvements in disease activity and patient-reported outcomes compared to Taltz monotherapy in TOGETHER-PsA study” lilly.com ↗

release “At the primary endpoint of 36 weeks, treatment with concomitant Taltz and Zepbound met the primary and all key secondary endpoints” lilly.com ↗

release “At 36 weeks, the TOGETHER-PsA study met its 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 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ixekizumab Monoclonal antibody — Subcutaneous
Subject Tirzepatide Peptide — Subcutaneous