Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
TOGETHER-PsA
Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)
2 other identifiers
interventional
279
2 countries
86
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2024
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
September 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJanuary 21, 2026
January 1, 2026
1.2 years
September 4, 2024
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments: 1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) 2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \_NRS) 3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS) 4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or 5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
Baseline up to Week 36
Secondary Outcomes (3)
Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction
Baseline up to Week 36
Percentage of Participants Achieving ACR50
Baseline up to Week 36
Percentage of Participants Achieving at Least a 10% Weight Reduction
Baseline up to Week 36
Study Arms (2)
Ixekizumab
EXPERIMENTALIxekizumab administered subcutaneous (SC).
Ixekizumab and Tirzepatide
EXPERIMENTALIxekizumab concomitantly administered with tirzepatide SC.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, 85392, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler, Arizona, 85225, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona, 86001, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert, Arizona, 85297, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, 85306, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa, Arizona, 85210, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix, Arizona, 85032, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City, Arizona, 85351, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
Tucson, Arizona, 85704, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson, Arizona, 85748, United States
Medvin Clinical Research - Apple Valley
Apple Valley, California, 92307, United States
Medvin Clinical Research - Covina
Covina, California, 91722, United States
Newport Huntington Medical Group
Huntington Beach, California, 92648, United States
Purushotham & Akther Kotha MD, Inc
La Mesa, California, 91942, United States
Medvin Clinical Research - Riverside
Riverside, California, 92508, United States
Rheumatology Center of San Diego
San Diego, California, 92128, United States
Medvin Clinical Research - Temecula
Temecula, California, 92592, United States
Cohen Medical Centers
Thousand Oaks, California, 91360, United States
Medvin Clinical Research - Tujunga
Tujunga, California, 91042, United States
Medvin Clinical Research - Whittier
Whittier, California, 90602, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765, United States
NeoClinical Research
Hialeah, Florida, 33016, United States
South Florida Rheumatology
Hollywood, Florida, 33021, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Vida Clinical Research
Kissimmee, Florida, 34741, United States
Life Clinical Trials
Margate, Florida, 33063, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Vitalia Medical Research
Palm Beach Gardens, Florida, 33410, United States
Sarasota Arthritis Center
Sarasota, Florida, 34239, United States
Clinical Research of West Florida
Tampa, Florida, 33606, United States
International Center for Research
Tampa, Florida, 33614, United States
Conquest Research
Winter Park, Florida, 32789, United States
Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
Gainesville, Georgia, 30501, United States
Atlanta Research Center for Rheumatology
Marietta, Georgia, 30060, United States
St. Luke's Clinic
Boise, Idaho, 83702, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Greater Chicago Specialty Physicians
Schaumburg, Illinois, 60195, United States
Arnold Arthritis & Rheumatology
Skokie, Illinois, 60076, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, 60527, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67207, United States
Accurate Clinical Research, Inc
Lake Charles, Louisiana, 70605, United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, 21502, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
NECCR PrimaCare Research
Fall River, Massachusetts, 02721, United States
Advanced Rheumatology, PC
Okemos, Michigan, 48864, United States
Saint Paul Rheumatology
Eagan, Minnesota, 55121, United States
AARA Clinical Research - Kansas City Physician Partners - North
Kansas City, Missouri, 64151, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Arthritis Consultants, Inc.
St Louis, Missouri, 63141, United States
Logan Health Research
Kalispell, Montana, 59901, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102, United States
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, 87505, United States
St. Lawrence Health System
Canton, New York, 13617, United States
Onsite Clinical Solutions, LLC - Brenner Ave
Salisbury, North Carolina, 28144, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
RAO Research LLC
Oklahoma City, Oklahoma, 73116, United States
Essential Medical Research
Tulsa, Oklahoma, 74137, United States
Summit Headlands
Portland, Oregon, 97210, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
AARA Clinical Research - Murfreesboro Medical Clinic
Murfreesboro, Tennessee, 37128, United States
Tekton Research, LLC.
Austin, Texas, 78745, United States
Accurate Clinical Management, LLC
Baytown, Texas, 77521, United States
Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville, Texas, 76034, United States
Arthritis Care of Texas
Corpus Christi, Texas, 78415, United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
Fort Worth, Texas, 76109, United States
Accurate Clinical Research, Inc
Houston, Texas, 77089, United States
Research Physicians Network, LLC
Houston, Texas, 77089, United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
Irving, Texas, 75039, United States
Biopharma Informatic, LLC
Katy, Texas, 77494, United States
West Texas Clinical Research
Lubbock, Texas, 79424, United States
Valley Arthritis Center
McAllen, Texas, 78501, United States
SouthWest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
Advanced Rheumatology of Houston - Woodlands
The Woodlands, Texas, 77382, United States
DM Clinical Research - TRA
Tomball, Texas, 77375, United States
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, 98004, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801, United States
Centro Reumatologico Caguas
Caguas, 00725, Puerto Rico
Reuviva Research Center
Guaynabo, 00968, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917, Puerto Rico
Caribbean Medical Research Center
San Juan, 00918, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
Related Publications (1)
Merola JF, Mease P, Kivitz A, Sattar N, Coates LC, Aletaha D, Kartman CE, Fischer P, Sun L, Martinez-Osuna P, Kronbergs A, Prajapati P, Cardoso A, Genovese MC, Ogdie A. Ixekizumab With Tirzepatide Achieved Greater Disease Control Than Ixekizumab Alone in Adults With Psoriatic Arthritis and Overweight or Obesity: Results From a Randomized Clinical Trial. Arthritis Rheumatol. 2026 Mar 28. doi: 10.1002/art.70134. Online ahead of print.
PMID: 41903163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 19, 2024
Study Start
September 24, 2024
Primary Completion
November 18, 2025
Study Completion
April 1, 2026
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.