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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 · Eli Lilly and Company
In plain English
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Official title
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
About this 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.
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.
Study design
Enrollment target: 200 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-19
Estimated completion: 2028-05
Last updated: 2026-04-17
Interventions
Drug: Tirzepatide
Primary outcomes
- • Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) (12 months)
- • Percentage of Participants Achieving at least 10% Weight Reduction (12 months)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (43)
Medical Dermatology SpecialistsRecruiting
Phoenix, Arizona, United States
First OC Dermatology Research IncRecruiting
Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc.Recruiting
Fremont, California, United States
Metropolis DermatologyRecruiting
Los Angeles, California, United States
Northridge Clinical TrialsRecruiting
Northridge, California, United States
Alliance for Multispecialty Research, LLCRecruiting
Fort Myers, Florida, United States
NeoClinical ResearchRecruiting
Hialeah, Florida, United States
Skin Care ResearchRecruiting
Hollywood, Florida, United States
Encore Medical ResearchRecruiting
Hollywood, Florida, United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical ResearchRecruiting
Tampa, Florida, United States
TruDerm & TruSpaRecruiting
Wellington, Florida, United States
Southeast Research SpecialistsRecruiting
Douglasville, Georgia, United States
Dawes Fretzin Clinical Research Group, LLCRecruiting
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PCRecruiting
Plainfield, Indiana, United States
Equity Medical - Bowling GreenRecruiting
Bowling Green, Kentucky, United States
Dermatology and Skin Cancer Specialists, LLCRecruiting
Rockville, Maryland, United States
Metro Boston Clinical PartnersRecruiting
Brighton, Massachusetts, United States
David Fivenson, MD, PLCRecruiting
Ann Arbor, Michigan, United States
Great Lakes Research Group, Inc.Recruiting
Bay City, Michigan, United States
The Derm Institute of West MichiganRecruiting
Caledonia, Michigan, United States
Skin Cancer and Dermatology Institute - RenoRecruiting
Reno, Nevada, United States
StracskinRecruiting
Portsmouth, New Hampshire, United States
Psoriasis Treatment Center of Central New JerseyRecruiting
East Windsor, New Jersey, United States
Care Access - HobokenRecruiting
Hoboken, New Jersey, United States
Equity MedicalRecruiting
New York, New York, United States
Revival Research Institute, LLCRecruiting
Cary, North Carolina, United States
Onsite Clinical Solutions - HuntersvilleRecruiting
Huntersville, North Carolina, United States
Optima Research - BoardmanRecruiting
Boardman, Ohio, United States
Oregon Dermatology and Research CenterRecruiting
Portland, Oregon, United States
Dermatology Associates of Plymouth MeetingRecruiting
Plymouth Meeting, Pennsylvania, United States
Columbia Dermatology & AestheticsRecruiting
Columbia, South Carolina, United States
Alliance for Multispecialty Research, LLCRecruiting
Myrtle Beach, South Carolina, United States
DelRicht Research - Thompson's StationRecruiting
Smyrna, Tennessee, United States
Bellaire Dermatology AssociatesRecruiting
Bellaire, Texas, United States
Modern Research Associates, PLLCRecruiting
Dallas, Texas, United States
Center for Clinical StudiesRecruiting
Houston, Texas, United States
Austin Institute for Clinical ResearchRecruiting
Pflugerville, Texas, United States
Texas Dermatology and Laser SpecialistsRecruiting
San Antonio, Texas, United States
Center for Clinical StudiesRecruiting
Webster, Texas, United States
Tanner ClinicRecruiting
Layton, Utah, United States
Bellevue Dermatology ClinicRecruiting
Bellevue, Washington, United States
Dermatology of SeattleRecruiting
Burien, Washington, United States
Office of Dr. Alma M. CruzRecruiting
Carolina, Puerto Rico