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 · NCT06857942 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
- ther 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
39 locations listed across 22 US states.
- Medical Dermatology Specialists - Phoenix, Arizona, United States
- First OC Dermatology Research Inc - Fountain Valley, California, United States
- Center For Dermatology Clinical Research, Inc. - Fremont, California, United States
- Metropolis Dermatology - Los Angeles, California, United States
- Northridge Clinical Trials - Northridge, California, United States
- NeoClinical Research - Hialeah, Florida, United States
- Skin Care Research - Hollywood, Florida, United States
- Encore Medical Research - Hollywood, Florida, United States
- MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research - Tampa, Florida, United States
- TruDerm & TruSpa - Wellington, Florida, United States
- Southeast Research Specialists - Douglasville, Georgia, United States
- Dawes Fretzin Clinical Research Group, LLC - Indianapolis, Indiana, United States
- The Indiana Clinical Trials Center, PC - Plainfield, Indiana, United States
- Equity Medical - Bowling Green - Bowling Green, Kentucky, United States
- Dermatology and Skin Cancer Specialists, LLC - Rockville, Maryland, United States
- Metro Boston Clinical Partners - Brighton, Massachusetts, United States
- David Fivenson, MD, PLC - Ann Arbor, Michigan, United States
- The Derm Institute of West Michigan - Caledonia, Michigan, United States
- Skin Cancer and Dermatology Institute - Reno - Reno, Nevada, United States
- Stracskin - Portsmouth, New Hampshire, United States
- Psoriasis Treatment Center of Central New Jersey - East Windsor, New Jersey, United States
- Care Access - Hoboken - Hoboken, New Jersey, United States
- Equity Medical - New York, New York, United States
- Revival Research Institute, LLC - Cary, North Carolina, United States
- Onsite Clinical Solutions - Huntersville - Huntersville, North Carolina, United States
- Optima Research - Boardman - Boardman, Ohio, United States
- Oregon Dermatology and Research Center - Portland, Oregon, United States
- Dermatology Associates of Plymouth Meeting - Plymouth Meeting, Pennsylvania, United States
- Columbia Dermatology & Aesthetics - Columbia, South Carolina, United States
- DelRicht Research - Thompson's Station - Smyrna, Tennessee, United States
- Bellaire Dermatology Associates - Bellaire, Texas, United States
- Modern Research Associates, PLLC - Dallas, Texas, United States
- Center for Clinical Studies - Houston, Texas, United States
- Austin Institute for Clinical Research - Pflugerville, Texas, United States
- Texas Dermatology and Laser Specialists - San Antonio, Texas, United States
- Center for Clinical Studies - Webster, Texas, United States
- Tanner Clinic - Layton, Utah, United States
- Bellevue Dermatology Clinic - Bellevue, Washington, United States
- Dermatology of Seattle - Burien, Washington, United States