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)

Recruiting now · Phase 4

Conditions studied: Psoriasis, Overweight or Obesity

In brief

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.

Key facts

Study ID

NCT06857942

Run by

Eli Lilly and Company

People needed

200

Starts

2025-03-19

Expected to finish

2028-05-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Medical Dermatology Specialists — Phoenix, Arizona, United States (enrolling)
• First OC Dermatology Research Inc — Fountain Valley, California, United States (enrolling)
• Center For Dermatology Clinical Research, Inc. — Fremont, California, United States (enrolling)
• Metropolis Dermatology — Los Angeles, California, United States (enrolling)
• Northridge Clinical Trials — Northridge, California, United States (enrolling)
• NeoClinical Research — Hialeah, Florida, United States (enrolling)
• Skin Care Research — Hollywood, Florida, United States (enrolling)
• Encore Medical Research — Hollywood, Florida, United States (enrolling)
• MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research — Tampa, Florida, United States (enrolling)
• TruDerm & TruSpa — Wellington, Florida, United States (enrolling)
• Southeast Research Specialists — Douglasville, Georgia, United States (enrolling)
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (enrolling)
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States (enrolling)
• Equity Medical - Bowling Green — Bowling Green, Kentucky, United States (enrolling)
• Dermatology and Skin Cancer Specialists, LLC — Rockville, Maryland, United States (enrolling)
• Metro Boston Clinical Partners — Brighton, Massachusetts, United States (enrolling)
• David Fivenson, MD, PLC — Ann Arbor, Michigan, United States (enrolling)
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States (enrolling)
• The Derm Institute of West Michigan — Caledonia, Michigan, United States (enrolling)
• Skin Cancer and Dermatology Institute - Reno — Reno, Nevada, United States (enrolling)
• Stracskin — Portsmouth, New Hampshire, United States (enrolling)
• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States (enrolling)
• Care Access - Hoboken — Hoboken, New Jersey, United States (enrolling)
• Equity Medical — New York, New York, United States (enrolling)
• Revival Research Institute, LLC — Cary, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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