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PsoriasisPhase 4NCT06857942

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)

A Phase 4 study testing Tirzepatide in people with Psoriasis and Overweight or Obesity, run by Eli Lilly and Company at 38 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis, Overweight or Obesity
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
38 sitesUnited States
Study dates
19 Mar 2025to May 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

38 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

38 sites in 1 country

United States38 sites, 38 recruiting

  • David Fivenson, MD, PLC

    Ann Arbor, Michigan, 48103

    734-222-9630

    David Fivenson

    Recruiting

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401

    713-661-4383

    Craig Teller

    Recruiting

  • Bellevue Dermatology Clinic

    Bellevue, Washington, 98104

    425-455-2275

    Clive Liu

    Recruiting

  • Optima Research - Boardman

    Boardman, Ohio, 44512

    330-422-3234

    Patrick Shannon

    Recruiting

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky, 42104

    270-213-7777

    James Allred

    Recruiting

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135

    Mark Amster

    Recruiting

  • The Derm Institute of West Michigan

    Caledonia, Michigan, 49316

    616-326-0114

    Kristi Hawley

    Recruiting

  • Revival Research Institute, LLC

    Cary, North Carolina, 27511

    Zain Husain

    Recruiting

  • Columbia Dermatology & Aesthetics

    Columbia, South Carolina, 29212

    803-731-9600

    Jessica Burgy

    Recruiting

  • Modern Research Associates, PLLC

    Dallas, Texas, 75231

    214-361-2008

    Jennifer Cather

    Recruiting

  • Southeast Research Specialists

    Douglasville, Georgia, 30135

    678-702-3376

    Firas George Hougeir

    Recruiting

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey, 08520

    Alexa Hetzel

    Recruiting

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

    714-531-2966

    Vivian Laquer

    Recruiting

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California, 94538

    510-797-0140

    Sunil Dhawan

    Recruiting

  • NeoClinical Research

    Hialeah, Florida, 33016

    305-456-9062

    Martin Zaiac, MD

    Recruiting

  • Care Access - Hoboken

    Hoboken, New Jersey, 07030

    551-278-8680

    Adolfo Fernandez- Obregon

    Recruiting

  • Skin Care Research

    Hollywood, Florida, 33021

    954-674-3535

    Eduardo Weiss

    Recruiting

  • Encore Medical Research

    Hollywood, Florida, 33024

    954-400-1725

    Jerome Obed

    Recruiting

  • Center for Clinical Studies

    Houston, Texas, 77004

    713-528-8818

    Stephen Tyring

    Recruiting

  • Onsite Clinical Solutions - Huntersville

    Huntersville, North Carolina, 28078

    800-785-3150

    Nicole Seminara-Zambrzycka

    Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

    317-516-5030

    Scott Fretzin

    Recruiting

  • Tanner Clinic

    Layton, Utah, 84041

    Scott Checketts

    Recruiting

  • Metropolis Dermatology

    Los Angeles, California, 90017

    424-393-0005

    Yen (James) Wang

    Recruiting

  • Equity Medical

    New York, New York, 10023

    212-466-6550

    Michael Cameron

    Recruiting

  • Northridge Clinical Trials

    Northridge, California, 91325

    818-350-7482

    Navid Ezra

    Recruiting

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

    512-279-2545

    Edward Lain

    Recruiting

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006

    602-354-5770

    Lindsay Ackerman

    Recruiting

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana, 46168

    317-837-6082

    Scott Guenthner

    Recruiting

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462

    Jonathan Wolfe

    Recruiting

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

    503-226-3376

    Phoebe Rich, MD

    Recruiting

  • Stracskin

    Portsmouth, New Hampshire, 03801

    617-833-9995

    Abel Jarell

    Recruiting

  • Skin Cancer and Dermatology Institute - Reno

    Reno, Nevada, 89509

    775-336-3658

    Michael Heaphy

    Recruiting

  • Dermatology and Skin Cancer Specialists, LLC

    Rockville, Maryland, 20850

    Benjamin Lockshin

    Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

    210-852-2779

    John Browning

    Recruiting

  • DelRicht Research - Thompson's Station

    Smyrna, Tennessee, 37167

    629-895-1775

    Pezhman Shoureshi

    Recruiting

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

    Tampa, Florida, 33607

    813-948-7550

    Stephen Lockwood

    Recruiting

  • Center for Clinical Studies

    Webster, Texas, 77598

    281-333-2288

    PATRICIA LEE

    Recruiting

  • TruDerm & TruSpa

    Wellington, Florida, 33449

    Andleeb Usmani

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Tirzepatide
Medical subject headings
Psoriasis, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06857942
Study groupRoleWhat they receive
TirzepatideExperimentalParticipants will continue to receive ixekizumab and take tirzepatide subcutaneously (SC) as per label.
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. Percentage of Participants Achieving at least 10% Weight Reduction

    Percentage of participants achieving at least 10% weight reduction.

    Measured: 12 months

Secondary outcomes (7)

  1. 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.

    Measured: Month 6 and Month 12

  2. 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.

    Measured: Month 6 and Month 12

  3. 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).

    Measured: Month 6 and Month 12

  4. 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.

    Measured: Month 6 and Month 12

  5. 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.

    Measured: Month 6 and Month 12

  6. Mean Percent Change of Weight from Baseline

    Mean percent change of weight from baseline.

    Measured: Baseline, Month 6 and Baseline, Month 12

  7. 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.

    Measured: Month 6 and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start19 Mar 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06857942
Sponsor's protocol ID
27319
Other IDs
I1F-MC-RHDD
Status last verified
Nov 2026
First submitted
3 Mar 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tirzepatide in people with Psoriasis and Overweight or Obesity, run by Eli Lilly and Company at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06857942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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