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)

Launched by ELI LILLY AND COMPANY · Mar 4, 2025

Keywords

ClinConnect Summary

The TOGETHER AMPLIFY-PsA clinical trial is studying how effective the medication tirzepatide is when added to ixekizumab treatment for people with active psoriatic arthritis (PsA) who are also overweight or obese. Psoriatic arthritis is a type of arthritis that causes joint pain and skin problems. The study aims to find out if combining these two treatments can help manage symptoms better for patients. It will last for up to 12 months and is currently looking for participants.

To be eligible for this trial, participants must have a diagnosis of active psoriatic arthritis and a body mass index (BMI) of 27 or higher, along with at least one weight-related health issue, such as high blood pressure or diabetes. Additionally, participants should have been treated with ixekizumab for about three months before starting tirzepatide. Those who qualify can expect regular check-ups and assessments throughout the study to monitor their health and how well the treatments are working together. It's important to note that not everyone will qualify, as certain health conditions and prior treatments may exclude individuals from participating.

Gender

ALL

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.