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)

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.

Conditions

Psoriasis, Overweight or Obesity

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Study Overview

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Study Details

Study overview

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.

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

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)

Condition
Psoriasis
Intervention / Treatment

-

Contacts and Locations

Phoenix

Medical Dermatology Specialists, Phoenix, Arizona, United States, 85006

Scottsdale

Scottsdale Clinical Trials, Scottsdale, Arizona, United States, 85260

Fountain Valley

First OC Dermatology Research Inc, Fountain Valley, California, United States, 92708

Northridge

Northridge Clinical Trials, Northridge, California, United States, 91325

Fort Myers

Alliance for Multispecialty Research, LLC, Fort Myers, Florida, United States, 33912

Hialeah

NeoClinical Research, Hialeah, Florida, United States, 33016

Hollywood

Encore Medical Research, Hollywood, Florida, United States, 33024

Tampa

Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research, Tampa, Florida, United States, 33609

Douglasville

Southeast Research Specialists, Douglasville, Georgia, United States, 30135

Indianapolis

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States, 46250

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-10