A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)

Launched by ELI LILLY AND COMPANY · Mar 3, 2025

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ClinConnect Summary

The TOGETHER AMPLIFY-PsO clinical trial is studying how effective a new medication called tirzepatide is when added to an existing treatment, ixekizumab, for people with moderate-to-severe plaque psoriasis (a skin condition that causes red, itchy patches) who are also overweight or obese. This study aims to see if using tirzepatide can help improve treatment outcomes for these individuals over a period of up to 12 months.

To be eligible for this trial, participants must have a diagnosis of moderate-to-severe plaque psoriasis and a body mass index (BMI) of 27 or higher, indicating they are overweight or obese. They should also have been on ixekizumab treatment for about three months before starting the study. Participants can expect regular check-ins and assessments during the trial to monitor their progress and any side effects. It’s important to note that certain medical conditions or previous treatments may exclude someone from participating, so potential candidates should review the eligibility criteria carefully.

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Eligibility criteria

• Inclusion Criteria:
• • Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant)
• • Have 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 mellitus, obstructive sleep apnea, or cardiovascular diseases).
• • Must have initiated treatment 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/screening).
• Exclusion Criteria:
• • Have currently received ixekizumab for more than 4 months or less than 2 months.
• • Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide.
• • Are currently enrolled in any other clinical study.
• • Other exclusions
• • Have a known hypersensitivity to tirzepatide or to any of its component.
• • Have a personal or family history of medullary thyroid cancer.
• • Have multiple endocrine neoplasia type 2.
• • Have type I diabetes mellitus.
• • Have a history of chronic or acute pancreatitis at any time before screening (Visit 1).
• • 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 and hypoglycemia unawareness within the 6 months before screening.
• • Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.