Clinical trial
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 · 1 countries · Registry ID NCT06857942
Recruiting nowPhase 4Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionPsoriasis, Overweight or Obesity
Full registry 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.
Treatments and study arms
Tirzepatide
Drug
Administered SC
Primary outcomes
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1)12 months
The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.
Percentage of Participants Achieving at least 10% Weight Reduction12 months
Percentage of participants achieving at least 10% weight reduction.
Study locations
39 locations were listed when this page was built. The first 40 are shown.
David Fivenson, MD, PLC🇺🇸 Ann Arbor, Michigan, United States
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David FivensonPrincipal Investigator
Bellaire Dermatology Associates🇺🇸 Bellaire, Texas, United States
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Craig TellerPrincipal Investigator
Bellevue Dermatology Clinic🇺🇸 Bellevue, Washington, United States
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Clive LiuPrincipal Investigator
Optima Research - Boardman🇺🇸 Boardman, Ohio, United States
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Patrick ShannonPrincipal Investigator
Equity Medical - Bowling Green🇺🇸 Bowling Green, Kentucky, United States
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James AllredPrincipal Investigator
Metro Boston Clinical Partners🇺🇸 Brighton, Massachusetts, United States
Mark AmsterPrincipal Investigator
Dermatology of Seattle🇺🇸 Burien, Washington, United States
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Elie LevyPrincipal Investigator
The Derm Institute of West Michigan🇺🇸 Caledonia, Michigan, United States
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Kristi HawleyPrincipal Investigator
Revival Research Institute, LLC🇺🇸 Cary, North Carolina, United States
Zain HusainPrincipal Investigator
Columbia Dermatology & Aesthetics🇺🇸 Columbia, South Carolina, United States
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Jessica BurgyPrincipal Investigator
Modern Research Associates, PLLC🇺🇸 Dallas, Texas, United States
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Jennifer CatherPrincipal Investigator
Southeast Research Specialists🇺🇸 Douglasville, Georgia, United States
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Firas George HougeirPrincipal Investigator
Psoriasis Treatment Center of Central New Jersey🇺🇸 East Windsor, New Jersey, United States
Alexa HetzelPrincipal Investigator
First OC Dermatology Research Inc🇺🇸 Fountain Valley, California, United States
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Vivian LaquerPrincipal Investigator
Center For Dermatology Clinical Research, Inc.🇺🇸 Fremont, California, United States
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Sunil DhawanPrincipal Investigator
NeoClinical Research🇺🇸 Hialeah, Florida, United States
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Martin Zaiac, MDPrincipal Investigator
Care Access - Hoboken🇺🇸 Hoboken, New Jersey, United States
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Adolfo Fernandez- ObregonPrincipal Investigator
Encore Medical Research🇺🇸 Hollywood, Florida, United States
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Jerome ObedPrincipal Investigator
Skin Care Research🇺🇸 Hollywood, Florida, United States
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Eduardo WeissPrincipal Investigator
Center for Clinical Studies🇺🇸 Houston, Texas, United States
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Stephen TyringPrincipal Investigator
Onsite Clinical Solutions - Huntersville🇺🇸 Huntersville, North Carolina, United States
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Nicole Seminara-ZambrzyckaPrincipal Investigator
Dawes Fretzin Clinical Research Group, LLC🇺🇸 Indianapolis, Indiana, United States
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Scott FretzinPrincipal Investigator
Metropolis Dermatology🇺🇸 Los Angeles, California, United States
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Yen (James) WangPrincipal Investigator
Equity Medical🇺🇸 New York, New York, United States
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Michael CameronPrincipal Investigator
Northridge Clinical Trials🇺🇸 Northridge, California, United States
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Navid EzraPrincipal Investigator
Austin Institute for Clinical Research🇺🇸 Pflugerville, Texas, United States
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Edward LainPrincipal Investigator
Medical Dermatology Specialists🇺🇸 Phoenix, Arizona, United States
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Lindsay AckermanPrincipal Investigator
The Indiana Clinical Trials Center, PC🇺🇸 Plainfield, Indiana, United States
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Scott GuenthnerPrincipal Investigator
Dermatology Associates of Plymouth Meeting🇺🇸 Plymouth Meeting, Pennsylvania, United States
Jonathan WolfePrincipal Investigator
Oregon Dermatology and Research Center🇺🇸 Portland, Oregon, United States
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Phoebe Rich, MDPrincipal Investigator
Stracskin🇺🇸 Portsmouth, New Hampshire, United States
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Abel JarellPrincipal Investigator
Skin Cancer and Dermatology Institute - Reno🇺🇸 Reno, Nevada, United States
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Michael HeaphyPrincipal Investigator
Dermatology and Skin Cancer Specialists, LLC🇺🇸 Rockville, Maryland, United States
Benjamin LockshinPrincipal Investigator
Texas Dermatology and Laser Specialists🇺🇸 San Antonio, Texas, United States
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John BrowningPrincipal Investigator
DelRicht Research - Thompson's Station🇺🇸 Smyrna, Tennessee, United States
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Pezhman ShoureshiPrincipal Investigator
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research🇺🇸 Tampa, Florida, United States
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Stephen LockwoodPrincipal Investigator
Center for Clinical Studies🇺🇸 Webster, Texas, United States
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PATRICIA LEEPrincipal Investigator