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Набира участници Фаза 4 NCT06857942

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)

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Psoriasis Overweight or Obesity

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
Tirzepatide
DRUG
Места на провеждане 43
Puerto Rico (1)
Office of Dr. Alma M. Cruz
Carolina
САЩ (42)
David Fivenson, MD, PLC
Ann Arbor , Michigan
Great Lakes Research Group, Inc.
Bay City , Michigan
Bellaire Dermatology Associates
Bellaire , Texas
Bellevue Dermatology Clinic
Bellevue , Washington
Optima Research - Boardman
Boardman , Ohio
Equity Medical - Bowling Green
Bowling Green , Kentucky
Metro Boston Clinical Partners
Brighton , Massachusetts
Dermatology of Seattle
Burien , Washington
The Derm Institute of West Michigan
Caledonia , Michigan
Revival Research Institute, LLC
Cary , North Carolina
Columbia Dermatology & Aesthetics
Columbia , South Carolina
Modern Research Associates, PLLC
Dallas , Texas
Southeast Research Specialists
Douglasville , Georgia
Psoriasis Treatment Center of Central New Jersey
East Windsor , New Jersey
Alliance for Multispecialty Research, LLC
Fort Myers , Florida
First OC Dermatology Research Inc
Fountain Valley , California
Center For Dermatology Clinical Research, Inc.
Fremont , California
NeoClinical Research
Hialeah , Florida
Care Access - Hoboken
Hoboken , New Jersey
Skin Care Research
Hollywood , Florida
Encore Medical Research
Hollywood , Florida
Center for Clinical Studies
Houston , Texas
Onsite Clinical Solutions - Huntersville
Huntersville , North Carolina
Dawes Fretzin Clinical Research Group, LLC
Indianapolis , Indiana
Tanner Clinic
Layton , Utah
Metropolis Dermatology
Los Angeles , California
Alliance for Multispecialty Research, LLC
Myrtle Beach , South Carolina
Equity Medical
New York , New York
Northridge Clinical Trials
Northridge , California
Austin Institute for Clinical Research
Pflugerville , Texas
Medical Dermatology Specialists
Phoenix , Arizona
The Indiana Clinical Trials Center, PC
Plainfield , Indiana
Dermatology Associates of Plymouth Meeting
Plymouth Meeting , Pennsylvania
Oregon Dermatology and Research Center
Portland , Oregon
Stracskin
Portsmouth , New Hampshire
Skin Cancer and Dermatology Institute - Reno
Reno , Nevada
Dermatology and Skin Cancer Specialists, LLC
Rockville , Maryland
Texas Dermatology and Laser Specialists
San Antonio , Texas
DelRicht Research - Thompson's Station
Smyrna , Tennessee
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa , Florida
Center for Clinical Studies
Webster , Texas
TruDerm & TruSpa
Wellington , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
19.03.2025
Крайна дата
01.05.2028
Регистрационен номер
NCT06857942
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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