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)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Psoriasis,Overweight or Obesity
Age
18+
Phase
PHASE4
Participants Needed
200
Est. Completion Date
May 31, 2028
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT06857942
Study Number
I1F-MC-RHDD
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