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)

Lilly

Status and phase

Enrolling

Phase 4

Conditions

Overweight or Obesity

Psoriatic Arthritis

Treatments

Drug: Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06864026

27350

I1F-MC-RHDE (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe PsA and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.