RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-03-19
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06857942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * 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).
  3. * Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide.
  4. * Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline/screening).
  1. * Have currently received ixekizumab for more than 4 months or less than 2 months.
  2. * Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide.
  3. * Are currently enrolled in any other clinical study.
  4. * Have a known hypersensitivity to tirzepatide or to any of its component.
  5. * Have a personal or family history of medullary thyroid cancer.
  6. * Have multiple endocrine neoplasia type 2.
  7. * Have type I diabetes mellitus.
  8. * Have a history of chronic or acute pancreatitis at any time before screening (Visit 1).
  9. * Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
  10. * Have a history of ketoacidosis or hyperosmolar state/coma.
  11. * Have a history of severe hypoglycemia and hypoglycemia unawareness within the 6 months before screening.
  12. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
clinical_inquiry_hub@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Medical Dermatology Specialists
Phoenix, Arizona, 85006
United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
United States
First OC Dermatology Research Inc
Fountain Valley, California, 92708
United States
Northridge Clinical Trials
Northridge, California, 91325
United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, 33912
United States
NeoClinical Research
Hialeah, Florida, 33016
United States
Encore Medical Research
Hollywood, Florida, 33024
United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, 33609
United States
Southeast Research Specialists
Douglasville, Georgia, 30135
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104
United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850
United States
David Fivenson, MD, PLC
Ann Arbor, Michigan, 48103
United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
United States
The Derm Institute of West Michigan
Caledonia, Michigan, 49316
United States
Skin Cancer and Dermatology Institute - Reno
Reno, Nevada, 89509
United States
Stracskin
Portsmouth, New Hampshire, 03801
United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
United States
Care Access - Hoboken
Hoboken, New Jersey, 07030
United States
Equity Medical
New York, New York, 10023
United States
Onsite Clinical Solutions - Huntersville
Huntersville, North Carolina, 28078
United States
Optima Research - Boardman
Boardman, Ohio, 44512
United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210
United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
United States
Columbia Dermatology & Aesthetics
Columbia, South Carolina, 29212
United States
DelRicht Research - Thompson's Station
Smyrna, Tennessee, 37167
United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401
United States
Modern Research Associates, PLLC
Dallas, Texas, 75231
United States
Center for Clinical Studies
Houston, Texas, 77004
United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
United States
Center for Clinical Studies
Webster, Texas, 77598
United States
Tanner Clinic
Layton, Utah, 84041
United States
Bellevue Dermatology Clinic
Bellevue, Washington, 98104
United States
Dermatology of Seattle
Burien, Washington, 98168
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-19
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-03-19
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Psoriasis
  • Overweight or Obesity