Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ixekizumab
Ixekizumab administered subcutaneous (SC).
  • Drug: Ixekizumab
    Administered SC
    Other names:
    • LY2439821
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
  • Drug: Ixekizumab
    Administered SC
    Other names:
    • LY2439821
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176

Recruiting Locations

More Details

NCT ID
NCT06588296
Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.