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A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

NCT06864026 · Eli Lilly and Company
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Official title
A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice.
About this study
The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.
Eligibility criteria
Inclusion Criteria: * Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA. * Body Mass Index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m2 to \<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease). * Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide. * Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening). Exclusion Criteria: * Have currently received ixekizumab for more than 4 months or less than 2 months. * Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide). * Are currently enrolled in any other clinical study. * Have a known hypersensitivity to any component of tirzepatide. * Have a personal or family history of medullary thyroid cancer. * Have multiple endocrine neoplasia type 2. * Have type 1 diabetes mellitus. * Have a history of chronic or acute pancreatitis at any time before screening. * Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment. * Have a history of ketoacidosis or hyperosmolar state/coma. * Have a history of severe hypoglycemia unawareness within the 6 months before screening. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.
Study design
Enrollment target: 200 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-06
Estimated completion: 2027-11
Last updated: 2026-09-08
Interventions
Drug: Tirzepatide
Primary outcomes
  • Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy (12 Months)
  • Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy (12 Months)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (55)
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - AvondaleRecruiting
Avondale, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - ChandlerRecruiting
Chandler, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - FlagstaffActive Not Recruiting
Flagstaff, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - GilbertCompleted
Gilbert, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - GlendaleActive Not Recruiting
Glendale, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - MesaActive Not Recruiting
Mesa, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PVRecruiting
Phoenix, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun CityActive Not Recruiting
Sun City, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - TucsonActive Not Recruiting
Tucson, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson SoutheastRecruiting
Tucson, Arizona, United States
Medvin Clinical Research - Apple ValleyActive Not Recruiting
Apple Valley, California, United States
Medvin Clinical Research - CovinaCompleted
Covina, California, United States
Newport Huntington Medical GroupActive Not Recruiting
Huntington Beach, California, United States
Purushotham & Akther Kotha MD, IncActive Not Recruiting
La Mesa, California, United States
Medvin Clinical Research - RiversideActive Not Recruiting
Riverside, California, United States
Rheumatology Center of San DiegoActive Not Recruiting
San Diego, California, United States
Providence Saint John's Medical FoundationActive Not Recruiting
Santa Monica, California, United States
Medvin Clinical Research - TemeculaActive Not Recruiting
Temecula, California, United States
Medvin Clinical Research - TujungaRecruiting
Tujunga, California, United States
Medvin Clinical Research - WhittierActive Not Recruiting
Whittier, California, United States
Vida Clinical ResearchActive Not Recruiting
Kissimmee, Florida, United States
Life Clinical TrialsActive Not Recruiting
Margate, Florida, United States
CZ RheumatologyActive Not Recruiting
Miami Beach, Florida, United States
Vitalia Medical ResearchActive Not Recruiting
Palm Beach Gardens, Florida, United States
International Center for ResearchCompleted
Tampa, Florida, United States
Atlanta Research Center for RheumatologyActive Not Recruiting
Marietta, Georgia, United States
Satilla Rheumatology & Internal MedicineActive Not Recruiting
Waycross, Georgia, United States
Great Lakes Clinical Trials - RavenswoodActive Not Recruiting
Chicago, Illinois, United States
Greater Chicago Specialty PhysiciansActive Not Recruiting
Schaumburg, Illinois, United States
Arnold Arthritis & RheumatologyActive Not Recruiting
Skokie, Illinois, United States
Willow Rheumatology and Wellness PLLCActive Not Recruiting
Willowbrook, Illinois, United States
Lake Cumberland RheumatologyActive Not Recruiting
New Albany, Indiana, United States
Accurate Clinical Research, IncCompleted
Lake Charles, Louisiana, United States
Klein & Associates, M.D., P.A.Active Not Recruiting
Cumberland, Maryland, United States
Klein & Associates, M.D., P.A.Active Not Recruiting
Hagerstown, Maryland, United States
Clinical Research Institute of Michigan, LLCActive Not Recruiting
Saint Clair Shores, Michigan, United States
Logan Health RheumatologyActive Not Recruiting
Kalispell, Montana, United States
University of Rochester Medical CenterActive Not Recruiting
Rochester, New York, United States
Onsite Clinical Solutions, LLC - Brenner AveActive Not Recruiting
Salisbury, North Carolina, United States
Paramount Medical Research & Consulting, LLCActive Not Recruiting
Middleburg Heights, Ohio, United States
Essential Medical ResearchActive Not Recruiting
Tulsa, Oklahoma, United States
West Tennessee Research InstituteActive Not Recruiting
Jackson, Tennessee, United States
AARA Clinical Research - Murfreesboro Medical ClinicActive Not Recruiting
Murfreesboro, Tennessee, United States
Precision Comprehensive Clinical Research Solutions - ColleyvilleRecruiting
Colleyville, Texas, United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort WorthActive Not Recruiting
Fort Worth, Texas, United States
Accurate Clinical Research, IncRecruiting
Houston, Texas, United States
Research Physicians Network, LLCActive Not Recruiting
Houston, Texas, United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - IrvingActive Not Recruiting
Irving, Texas, United States
Biopharma Informatic, LLCActive Not Recruiting
Katy, Texas, United States
Advanced Rheumatology of Houston - WoodlandsActive Not Recruiting
The Woodlands, Texas, United States
DM Clinical Research - TRARecruiting
Tomball, Texas, United States
Seattle Rheumatology Associates PLLCActive Not Recruiting
Seattle, Washington, United States
Arthritis Northwest, PLLCActive Not Recruiting
Spokane Valley, Washington, United States
Reuviva Research CenterCompleted
Guaynabo, Puerto Rico
CMRC Headlands, LLCRecruiting
San Juan, Puerto Rico
A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA) · TrialPath