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)

Recruiting now · Phase 4

Conditions studied: Psoriatic Arthritis, Overweight or Obesity

In brief

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.

Key facts

Study ID

NCT06864026

Run by

Eli Lilly and Company

People needed

200

Starts

2025-03-06

Expected to finish

2027-11-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler — Chandler, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff — Flagstaff, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert — Gilbert, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa — Mesa, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV — Phoenix, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City — Sun City, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson — Tucson, Arizona, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast — Tucson, Arizona, United States (enrolling)
• Medvin Clinical Research - Apple Valley — Apple Valley, California, United States (enrolling)
• Medvin Clinical Research - Covina — Covina, California, United States (enrolling)
• Newport Huntington Medical Group — Huntington Beach, California, United States (enrolling)
• Purushotham & Akther Kotha MD, Inc — La Mesa, California, United States (enrolling)
• Medvin Clinical Research - Riverside — Riverside, California, United States (enrolling)
• Rheumatology Center of San Diego — San Diego, California, United States (enrolling)
• Providence Saint John's Medical Foundation — Santa Monica, California, United States (enrolling)
• Medvin Clinical Research - Temecula — Temecula, California, United States (enrolling)
• Medvin Clinical Research - Tujunga — Tujunga, California, United States (enrolling)
• Medvin Clinical Research - Whittier — Whittier, California, United States (enrolling)
• Vida Clinical Research — Kissimmee, Florida, United States (enrolling)
• Life Clinical Trials — Margate, Florida, United States (enrolling)
• CZ Rheumatology — Miami Beach, Florida, United States (enrolling)
• Vitalia Medical Research — Palm Beach Gardens, Florida, United States (enrolling)
• International Center for Research — Tampa, Florida, United States (enrolling)
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale — Avondale, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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