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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)

NCT06857942

RecruitingPhase 4

Sponsor: Eli Lilly and Company

Conditions: Psoriasis, Overweight or Obesity

Interventions: Tirzepatide

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (39)

Phoenix, Arizona, United States
Fountain Valley, California, United States
Fremont, California, United States
Los Angeles, California, United States
Northridge, California, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Hollywood, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Douglasville, Georgia, United States
Indianapolis, Indiana, United States
Plainfield, Indiana, United States
Bowling Green, Kentucky, United States
Rockville, Maryland, United States
Brighton, Massachusetts, United States
Ann Arbor, Michigan, United States
Caledonia, Michigan, United States
Reno, Nevada, United States
Portsmouth, New Hampshire, United States
East Windsor, New Jersey, United States
Hoboken, New Jersey, United States
New York, New York, United States
Cary, North Carolina, United States
Huntersville, North Carolina, United States
Boardman, Ohio, United States
Portland, Oregon, United States
Plymouth Meeting, Pennsylvania, United States
Columbia, South Carolina, United States
Smyrna, Tennessee, United States
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