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
Condition(s) studied
PsoriasisOverweight or Obesity
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
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)
- 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 Reduction — 12 months
Percentage of participants achieving at least 10% weight reduction.
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 →More Eli Lilly and Company trials in the USA
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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