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)
A Phase 4, Prospective, Open-Label, Single Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight in Clinical Practice
Eli Lilly and Company
200 participants
Mar 19, 2025
INTERVENTIONAL
Conditions
Summary
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 plaque PsO and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.
Eligibility
Inclusion Criteria4
- 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 Criteria13
- 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.
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Interventions
Administered SC
Locations(43)
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NCT06857942