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 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 27319I1F-MC-RHDD
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 43

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.

Conditions

Psoriasis; Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target]

  Month 6 and Month 12

• Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal)

  Month 6 and Month 12

• Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1)

  Month 6 and Month 12

• Percentage of Participants Achieving DLQI ≤5

  Month 6 and Month 12

• Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2

  Month 6 and Month 12

Study Arms (1)

Tirzepatide

EXPERIMENTAL

Participants will continue to receive ixekizumab and take tirzepatide subcutaneously (SC) as per label.

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

Tirzepatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (43)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

RECRUITING

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

RECRUITING

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

RECRUITING

Metropolis Dermatology

Los Angeles, California, 90017, United States

RECRUITING

Northridge Clinical Trials

Northridge, California, 91325, United States

RECRUITING

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, 33912, United States

RECRUITING

NeoClinical Research

Hialeah, Florida, 33016, United States

RECRUITING

Skin Care Research

Hollywood, Florida, 33021, United States

RECRUITING

Encore Medical Research

Hollywood, Florida, 33024, United States

RECRUITING

MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

Tampa, Florida, 33607, United States

RECRUITING

TruDerm & TruSpa

Wellington, Florida, 33449, United States

RECRUITING

Southeast Research Specialists

Douglasville, Georgia, 30135, United States

RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

RECRUITING

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

RECRUITING

Equity Medical - Bowling Green

Bowling Green, Kentucky, 42104, United States

RECRUITING

Dermatology and Skin Cancer Specialists, LLC

Rockville, Maryland, 20850, United States

RECRUITING

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

RECRUITING

David Fivenson, MD, PLC

Ann Arbor, Michigan, 48103, United States

RECRUITING

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

RECRUITING

The Derm Institute of West Michigan

Caledonia, Michigan, 49316, United States

RECRUITING

Skin Cancer and Dermatology Institute - Reno

Reno, Nevada, 89509, United States

RECRUITING

Stracskin

Portsmouth, New Hampshire, 03801, United States

RECRUITING

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

RECRUITING

Care Access - Hoboken

Hoboken, New Jersey, 07030, United States

RECRUITING

Equity Medical

New York, New York, 10023, United States

RECRUITING

Revival Research Institute, LLC

Cary, North Carolina, 27511, United States

RECRUITING

Onsite Clinical Solutions - Huntersville

Huntersville, North Carolina, 28078, United States

RECRUITING

Optima Research - Boardman

Boardman, Ohio, 44512, United States

RECRUITING

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

RECRUITING

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Columbia Dermatology & Aesthetics

Columbia, South Carolina, 29212, United States

RECRUITING

Alliance for Multispecialty Research, LLC

Myrtle Beach, South Carolina, 29588, United States

RECRUITING

DelRicht Research - Thompson's Station

Smyrna, Tennessee, 37167, United States

RECRUITING

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

RECRUITING

Modern Research Associates, PLLC

Dallas, Texas, 75231, United States

RECRUITING

Center for Clinical Studies

Houston, Texas, 77004, United States

RECRUITING

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Center for Clinical Studies

Webster, Texas, 77598, United States

RECRUITING

Tanner Clinic

Layton, Utah, 84041, United States

RECRUITING

Bellevue Dermatology Clinic

Bellevue, Washington, 98104, United States

RECRUITING

Dermatology of Seattle

Burien, Washington, 98168, United States

RECRUITING

Office of Dr. Alma M. Cruz

Carolina, 00985, Puerto Rico

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis; Overweight; Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 5, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Locations

US (42); PR (1)