NCT06588283: TOGETHER-PsO

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)

Active, enrolled Phase 3 Last updated 16 January 2026

What this trial tests

Phase 3 trial testing Ixekizumab in Psoriasis in 250 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 September 2024

Primary endpoint
8 January 2026

1 May 2026

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	30 September 2024
Primary completion	8 January 2026
Estimated completion	1 May 2026
Sites	72 locations across United States, Puerto Rico

Drugs / interventions tested

• Ixekizumab (ixekizumab) — full drug profile →
• Tirzepatide (TIRZEPATIDE) — full drug profile →

Conditions studied

• Psoriasis — all drugs for Psoriasis →
• Obesity — all drugs for Obesity →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Psoriasis or Obesity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  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 t

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The potential role of GLP-1 receptor agonists in the management of psoriatic disease: a scoping review.
   Buonanno S, Gaggiano C, Terribili R, Cantarini L, et al · · 2025 · cited 4× · PMID 41266905 · DOI 10.1007/s00011-025-02140-2
2. Ixekizumab With or Without Tirzepatide in Adults With Psoriasis and Overweight or Obesity: A Phase 3b Randomized Clinical Trial.
   Lebwohl M, Blauvelt A, Kartman CE, Leatherwood C, et al · · 2026 · PMID 42139049 · DOI 10.1001/jamadermatol.2026.1753
3. Editorial: Exploring innovative therapies for rare inflammatory skin diseases.
   Niebel D, Miše J, Wenzel J. · · 2026 · PMID 41939760 · DOI 10.3389/fmed.2026.1822888
4. The role of the incretin GIP in inflammation.
   Rossi G, Bucciarelli L, Cimino V, Fiorina P. · · 2026 · PMID 41082103 · DOI 10.1007/s40618-025-02719-w