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Clinical Trial NCT06857942 for Psoriasis, Overweight or Obesity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Eli Lilly and CompanyA 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) Phase 4 200
Clinical Trial NCT06857942 is designed to study Treatment for Psoriasis, Overweight or Obesity. It is a Phase 4 interventional study that is recruiting, having started on March 19, 2025, with plans to enroll 200 participants. Led by Eli Lilly and Company, it is expected to complete by May 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 19, 2026.
Brief 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.
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
Conditions
PsoriasisOverweight or ObesityOther Study IDs
- 27319
- I1F-MC-RHDD (Other Identifier) (Eli Lilly and Company)
NCT ID Number
Start Date (Actual)
2025-03-19
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-05
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTirzepatide Participants will continue to receive ixekizumab and take tirzepatide subcutaneously (SC) as per label. | Tirzepatide Administered SC |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) | 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. | 12 months |
Percentage of Participants Achieving at least 10% Weight Reduction | Percentage of participants achieving at least 10% weight reduction. | 12 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target] | The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area. | Month 6 and Month 12 |
Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal) | The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area. | Month 6 and Month 12 |
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1) | The sPGA is an investigator-administered multi-item scale. It determines the participant's psoriasis (PsO) lesions, overall, at a given time point. Overall lesions are graded for plaque elevation, scaling, and erythema, on a range of clear (0), almost clear (1), mild (2), moderate (3), and severe (4). | Month 6 and Month 12 |
Percentage of Participants Achieving DLQI ≤5 | 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. | Month 6 and Month 12 |
Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2 | The PatGA of Psoriasis is a patient-reported single-item scale. Patient Global Assessments allow for an overall evaluation of disease severity or global impact of the disease from the patient's perspective. Participants are asked to rank the severity of their PsO "today" by selecting a number on a 0-to-5 numeric rating scale, with 0 indicating clear/no PsO and 5 indicating severe PsO. | Month 6 and Month 12 |
Mean Percent Change of Weight from Baseline | Mean percent change of weight from baseline. | Baseline, Month 6 and Baseline, Month 12 |
Percentage of Participants Achieving DLQI Score (0,1) and Least 10% Weight Reduction | 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. | Month 6 and Month 12 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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).
- 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.
Eli Lilly and Company362 active studies to exploreStudy Central Contact
Contact: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, [email protected]
Contact: Physicians interested in becoming principal investigators please contact, [email protected]
43 Study Locations in 2 Countries
Arizona
Medical Dermatology Specialists, Phoenix, Arizona, 85006, United States
Contact, 602-354-5770
Lindsay Ackerman, Principal Investigator
Recruiting
California
First OC Dermatology Research Inc, Fountain Valley, California, 92708, United States
Contact, 714-531-2966
Vivian Laquer, Principal Investigator
Recruiting
Center For Dermatology Clinical Research, Inc., Fremont, California, 94538, United States
Contact, 510-797-0140
Sunil Dhawan, Principal Investigator
Recruiting
Metropolis Dermatology, Los Angeles, California, 90017, United States
Contact, 424-393-0005
Yen (James) Wang, Principal Investigator
Recruiting
Northridge Clinical Trials, Northridge, California, 91325, United States
Contact, 818-350-7482
Navid Ezra, Principal Investigator
Recruiting
Florida
Alliance for Multispecialty Research, LLC, Fort Myers, Florida, 33912, United States
Contact, 239-936-4421
Anais Badia, Principal Investigator
Recruiting
NeoClinical Research, Hialeah, Florida, 33016, United States
Contact, 305-456-9062
Martin Zaiac, MD, Principal Investigator
Recruiting
Skin Care Research, Hollywood, Florida, 33021, United States
Contact, 954-674-3535
Eduardo Weiss, Principal Investigator
Recruiting
Encore Medical Research, Hollywood, Florida, 33024, United States
Contact, 954-400-1725
Jerome Obed, Principal Investigator
Recruiting
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research, Tampa, Florida, 33609, United States
Stephen Lockwood, Principal Investigator
Recruiting
TruDerm & TruSpa, Wellington, Florida, 33449, United States
Andleeb Usmani, Principal Investigator
Recruiting
Georgia
Southeast Research Specialists, Douglasville, Georgia, 30135, United States
Contact, 678-702-3376
Firas George Hougeir, Principal Investigator
Recruiting
Indiana
Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, 46250, United States
Contact, 317-516-5030
Scott Fretzin, Principal Investigator
Recruiting
The Indiana Clinical Trials Center, PC, Plainfield, Indiana, 46168, United States
Contact, 317-837-6082
Scott Guenthner, Principal Investigator
Recruiting
Kentucky
Equity Medical - Bowling Green, Bowling Green, Kentucky, 42104, United States
Contact, 270-213-7777
James Allred, Principal Investigator
Recruiting
Maryland
Dermatology and Skin Cancer Specialists, LLC, Rockville, Maryland, 20850, United States
Benjamin Lockshin, Principal Investigator
Recruiting
Massachusetts
Metro Boston Clinical Partners, Brighton, Massachusetts, 02135, United States
Mark Amster, Principal Investigator
Recruiting
Michigan
David Fivenson, MD, PLC, Ann Arbor, Michigan, 48103, United States
Contact, 734-222-9630
David Fivenson, Principal Investigator
Recruiting
Great Lakes Research Group, Inc., Bay City, Michigan, 48706, United States
Contact, 989-895-9100
Brent Boyce, Principal Investigator
Recruiting
The Derm Institute of West Michigan, Caledonia, Michigan, 49316, United States
Contact, 616-326-0114
Kristi Hawley, Principal Investigator
Recruiting
Nevada
Skin Cancer and Dermatology Institute - Reno, Reno, Nevada, 89509, United States
Contact, 775-336-3658
Michael Heaphy, Principal Investigator
Recruiting
New Hampshire
Stracskin, Portsmouth, New Hampshire, 03801, United States
Contact, 617-833-9995
Abel Jarell, Principal Investigator
Recruiting
New Jersey
Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey, 08520, United States
Alexa Hetzel, Principal Investigator
Recruiting
Care Access - Hoboken, Hoboken, New Jersey, 07030, United States
Contact, 551-278-8680
Adolfo Fernandez- Obregon, Principal Investigator
Recruiting
New York
Equity Medical, New York, New York, 10023, United States
Contact, 212-466-6550
Michael Cameron, Principal Investigator
Recruiting
North Carolina
Revival Research Institute, LLC, Cary, North Carolina, 27511, United States
Zain Husain, Principal Investigator
Recruiting
Onsite Clinical Solutions - Huntersville, Huntersville, North Carolina, 28078, United States
Contact, 800-785-3150
Nicole Seminara-Zambrzycka, Principal Investigator
Recruiting
Ohio
Optima Research - Boardman, Boardman, Ohio, 44512, United States
Contact, 330-422-3234
Patrick Shannon, Principal Investigator
Recruiting
Oregon
Oregon Dermatology and Research Center, Portland, Oregon, 97210, United States
Contact, 503-226-3376
Phoebe Rich, MD, Principal Investigator
Recruiting
Pennsylvania
Dermatology Associates of Plymouth Meeting, Plymouth Meeting, Pennsylvania, 19462, United States
Jonathan Wolfe, Principal Investigator
Recruiting
South Carolina
Columbia Dermatology & Aesthetics, Columbia, South Carolina, 29212, United States
Contact, 803-731-9600
Jessica Burgy, Principal Investigator
Recruiting
Alliance for Multispecialty Research, LLC, Myrtle Beach, South Carolina, 29588, United States
Brandon Coakley, Principal Investigator
Recruiting
Tennessee
DelRicht Research - Thompson's Station, Smyrna, Tennessee, 37167, United States
Contact, 504-336-2667
Pezhman Shoureshi, Principal Investigator
Recruiting
Texas
Bellaire Dermatology Associates, Bellaire, Texas, 77401, United States
Contact, 713-661-4383
Craig Teller, Principal Investigator
Recruiting
Modern Research Associates, PLLC, Dallas, Texas, 75231, United States
Contact, 214-361-2008
Jennifer Cather, Principal Investigator
Recruiting
Center for Clinical Studies, Houston, Texas, 77004, United States
Contact, 713-528-8818
Stephen Tyring, Principal Investigator
Recruiting
Austin Institute for Clinical Research, Pflugerville, Texas, 78660, United States
Contact, 512-279-2545
Edward Lain, Principal Investigator
Recruiting
Texas Dermatology and Laser Specialists, San Antonio, Texas, 78218, United States
Contact, 210-852-2779
John Browning, Principal Investigator
Recruiting
Center for Clinical Studies, Webster, Texas, 77598, United States
Contact, 281-333-2288
PATRICIA LEE, Principal Investigator
Recruiting
Utah
Tanner Clinic, Layton, Utah, 84041, United States
Scott Checketts, Principal Investigator
Recruiting
Washington
Bellevue Dermatology Clinic, Bellevue, Washington, 98104, United States
Contact, 425-455-2275
Clive Liu, Principal Investigator
Recruiting
Dermatology of Seattle, Burien, Washington, 98168, United States
Contact, 206-248-5020
Elie Levy, Principal Investigator
Recruiting
Office of Dr. Alma M. Cruz, Carolina, 00985, Puerto Rico
Contact, 7877691954
Alma M. Cruz-Santana, Principal Investigator
Recruiting