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Clinical Trials in the USA / NCT06857942
Recruiting Phase 4

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 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 4
Started
2025-03-19
Last updated
2026-09-04

Condition(s) studied

PsoriasisOverweight or Obesity

Investigational drug(s) / intervention(s)

Tirzepatide

Tirzepatide: Administered SC

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Medical Dermatology Specialists Phoenix Arizona Recruiting
First OC Dermatology Research Inc Fountain Valley California Recruiting
Center For Dermatology Clinical Research, Inc. Fremont California Recruiting
Metropolis Dermatology Los Angeles California Recruiting
Northridge Clinical Trials Northridge California Recruiting
NeoClinical Research Hialeah Florida Recruiting
Skin Care Research Hollywood Florida Recruiting
Encore Medical Research Hollywood Florida Recruiting
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research Tampa Florida Recruiting
TruDerm & TruSpa Wellington Florida Recruiting
Southeast Research Specialists Douglasville Georgia Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
The Indiana Clinical Trials Center, PC Plainfield Indiana Recruiting
Equity Medical - Bowling Green Bowling Green Kentucky Recruiting
Dermatology and Skin Cancer Specialists, LLC Rockville Maryland Recruiting
Metro Boston Clinical Partners Brighton Massachusetts Recruiting
David Fivenson, MD, PLC Ann Arbor Michigan Recruiting
The Derm Institute of West Michigan Caledonia Michigan Recruiting
Skin Cancer and Dermatology Institute - Reno Reno Nevada Recruiting
Stracskin Portsmouth New Hampshire Recruiting
Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey Recruiting
Care Access - Hoboken Hoboken New Jersey Recruiting
Equity Medical New York New York Recruiting
Revival Research Institute, LLC Cary North Carolina Recruiting
Onsite Clinical Solutions - Huntersville Huntersville North Carolina Recruiting
Optima Research - Boardman Boardman Ohio Recruiting
Oregon Dermatology and Research Center Portland Oregon Recruiting
Dermatology Associates of Plymouth Meeting Plymouth Meeting Pennsylvania Recruiting
Columbia Dermatology & Aesthetics Columbia South Carolina Recruiting
DelRicht Research - Thompson's Station Smyrna Tennessee Recruiting
Bellaire Dermatology Associates Bellaire Texas Recruiting
Modern Research Associates, PLLC Dallas Texas Recruiting
Center for Clinical Studies Houston Texas Recruiting
Austin Institute for Clinical Research Pflugerville Texas Recruiting
Texas Dermatology and Laser Specialists San Antonio Texas Recruiting
Center for Clinical Studies Webster Texas Recruiting
Tanner Clinic Layton Utah Recruiting
Bellevue Dermatology Clinic Bellevue Washington Recruiting
Dermatology of Seattle Burien Washington Recruiting

On this site

📄 Mounjaro (tirzepatide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06857942 on ClinicalTrials.gov ↗ ← All trials in the USA