ClinicalTrials.gg
RecruitingNCT06857942Updated Nov 4, 2026

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 interventional study of Tirzepatide in Psoriasis and Overweight or Obesity, sponsored by Eli Lilly and Company. Recruiting at 38 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Updated Nov 4, 20261 site removedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Overweight or Obesity
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 200 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion 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 (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).

Exclusion criteria

Exclusion Criteria:

  • 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Tirzepatide

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

    Drug: Tirzepatide

Interventions

06

What researchers measure

Primary outcomes

  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.

    Time frame: 12 months

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

    Percentage of participants achieving at least 10% weight reduction.

    Time frame: 12 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: Month 6 and Month 12

  6. Mean Percent Change of Weight from Baseline

    Mean percent change of weight from baseline.

    Time frame: 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.

    Time frame: Month 6 and Month 12

07

Study locations

38 of 38 sites recruiting
  • Medical Dermatology Specialists
    Phoenix, Arizona 85006, United States
    Recruiting
    • · Contact602-354-5770
    • Lindsay Ackerman · Principal investigator
  • First OC Dermatology Research Inc
    Fountain Valley, California 92708, United States
    Recruiting
    • · Contact714-531-2966
    • Vivian Laquer · Principal investigator
  • Center For Dermatology Clinical Research, Inc.
    Fremont, California 94538, United States
    Recruiting
    • · Contact510-797-0140
    • Sunil Dhawan · Principal investigator
  • Metropolis Dermatology
    Los Angeles, California 90017, United States
    Recruiting
    • · Contact424-393-0005
    • Yen (James) Wang · Principal investigator
  • Northridge Clinical Trials
    Northridge, California 91325, United States
    Recruiting
    • · Contact818-350-7482
    • Navid Ezra · Principal investigator
  • NeoClinical Research
    Hialeah, Florida 33016, United States
    Recruiting
    • · Contact305-456-9062
    • Martin Zaiac, MD · Principal investigator
  • Skin Care Research
    Hollywood, Florida 33021, United States
    Recruiting
    • · Contact954-674-3535
    • Eduardo Weiss · Principal investigator
  • Encore Medical Research
    Hollywood, Florida 33024, United States
    Recruiting
    • · Contact954-400-1725
    • Jerome Obed · Principal investigator
  • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
    Tampa, Florida 33607, United States
    Recruiting
    • · Contact813-948-7550
    • Stephen Lockwood · Principal investigator
  • TruDerm & TruSpa
    Wellington, Florida 33449, United States
    Recruiting
    • Andleeb Usmani · Principal investigator
  • Southeast Research Specialists
    Douglasville, Georgia 30135, United States
    Recruiting
    • · Contact678-702-3376
    • Firas George Hougeir · Principal investigator
  • Dawes Fretzin Clinical Research Group, LLC
    Indianapolis, Indiana 46250, United States
    Recruiting
    • · Contact317-516-5030
    • Scott Fretzin · Principal investigator
  • The Indiana Clinical Trials Center, PC
    Plainfield, Indiana 46168, United States
    Recruiting
    • · Contact317-837-6082
    • Scott Guenthner · Principal investigator
  • Equity Medical - Bowling Green
    Bowling Green, Kentucky 42104, United States
    Recruiting
    • · Contact270-213-7777
    • James Allred · Principal investigator
  • Dermatology and Skin Cancer Specialists, LLC
    Rockville, Maryland 20850, United States
    Recruiting
    • Benjamin Lockshin · Principal investigator
  • Metro Boston Clinical Partners
    Brighton, Massachusetts 02135, United States
    Recruiting
    • Mark Amster · Principal investigator
  • David Fivenson, MD, PLC
    Ann Arbor, Michigan 48103, United States
    Recruiting
    • · Contact734-222-9630
    • David Fivenson · Principal investigator
  • The Derm Institute of West Michigan
    Caledonia, Michigan 49316, United States
    Recruiting
    • · Contact616-326-0114
    • Kristi Hawley · Principal investigator
  • Skin Cancer and Dermatology Institute - Reno
    Reno, Nevada 89509, United States
    Recruiting
    • · Contact775-336-3658
    • Michael Heaphy · Principal investigator
  • Stracskin
    Portsmouth, New Hampshire 03801, United States
    Recruiting
    • · Contact617-833-9995
    • Abel Jarell · Principal investigator
  • Psoriasis Treatment Center of Central New Jersey
    East Windsor, New Jersey 08520, United States
    Recruiting
    • Alexa Hetzel · Principal investigator
  • Care Access - Hoboken
    Hoboken, New Jersey 07030, United States
    Recruiting
    • · Contact551-278-8680
    • Adolfo Fernandez- Obregon · Principal investigator
  • Equity Medical
    New York, New York 10023, United States
    Recruiting
    • · Contact212-466-6550
    • Michael Cameron · Principal investigator
  • Revival Research Institute, LLC
    Cary, North Carolina 27511, United States
    Recruiting
    • Zain Husain · Principal investigator
  • Onsite Clinical Solutions - Huntersville
    Huntersville, North Carolina 28078, United States
    Recruiting
    • · Contact800-785-3150
    • Nicole Seminara-Zambrzycka · Principal investigator
  • Optima Research - Boardman
    Boardman, Ohio 44512, United States
    Recruiting
    • · Contact330-422-3234
    • Patrick Shannon · Principal investigator
  • Oregon Dermatology and Research Center
    Portland, Oregon 97210, United States
    Recruiting
    • · Contact503-226-3376
    • Phoebe Rich, MD · Principal investigator
  • Dermatology Associates of Plymouth Meeting
    Plymouth Meeting, Pennsylvania 19462, United States
    Recruiting
    • Jonathan Wolfe · Principal investigator
  • Columbia Dermatology & Aesthetics
    Columbia, South Carolina 29212, United States
    Recruiting
    • · Contact803-731-9600
    • Jessica Burgy · Principal investigator
  • DelRicht Research - Thompson's Station
    Smyrna, Tennessee 37167, United States
    Recruiting
    • · Contact629-895-1775
    • Pezhman Shoureshi · Principal investigator
  • Bellaire Dermatology Associates
    Bellaire, Texas 77401, United States
    Recruiting
    • · Contact713-661-4383
    • Craig Teller · Principal investigator
  • Modern Research Associates, PLLC
    Dallas, Texas 75231, United States
    Recruiting
    • · Contact214-361-2008
    • Jennifer Cather · Principal investigator
  • Center for Clinical Studies
    Houston, Texas 77004, United States
    Recruiting
    • · Contact713-528-8818
    • Stephen Tyring · Principal investigator
  • Austin Institute for Clinical Research
    Pflugerville, Texas 78660, United States
    Recruiting
    • · Contact512-279-2545
    • Edward Lain · Principal investigator
  • Texas Dermatology and Laser Specialists
    San Antonio, Texas 78218, United States
    Recruiting
    • · Contact210-852-2779
    • John Browning · Principal investigator
  • Center for Clinical Studies
    Webster, Texas 77598, United States
    Recruiting
    • · Contact281-333-2288
    • PATRICIA LEE · Principal investigator
  • Tanner Clinic
    Layton, Utah 84041, United States
    Recruiting
    • Scott Checketts · Principal investigator
  • Bellevue Dermatology Clinic
    Bellevue, Washington 98104, United States
    Recruiting
    • · Contact425-455-2275
    • Clive Liu · Principal investigator
08

References and documents

Related links

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

Data sharing details ↗ · vivli.org

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site removed
Show 1 removed
  • Dermatology of Seattle · Burien, United States
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    1 site removed
    Show 1 removed
    • Dermatology of Seattle · Burien, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06857942
Responsible party
Sponsor
First posted
Mar 5, 2025
Start date
Mar 19, 2025
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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