A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

February 9, 2026 updated by: Eli Lilly and Company

A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity 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 PsA and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Recruiting
        • Reuviva Research Center
        • Principal Investigator:
          • Ileana Vazquez-Otero
        • Contact:
          • Phone Number: 939-599-0382
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • CMRC Headlands, LLC
        • Principal Investigator:
          • Maria Chirino
  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
        • Principal Investigator:
          • Andrew Sharobeem
        • Contact:
          • Phone Number: 602-386-4971
      • Chandler, Arizona, United States, 85225
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
        • Contact:
          • Phone Number: 480-443-8400
        • Principal Investigator:
          • Amer Al-Khoudari
      • Flagstaff, Arizona, United States, 86001
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
        • Principal Investigator:
          • Alexander Hu
        • Contact:
          • Phone Number: 928-666-3772
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
        • Contact:
          • Phone Number: 480-443-8400
        • Principal Investigator:
          • Joonhee Lim
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
        • Principal Investigator:
          • Rajat Dhar
        • Contact:
          • Phone Number: 602-386-4969
      • Mesa, Arizona, United States, 85210
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
        • Principal Investigator:
          • Matthew Herrmann
        • Contact:
          • Phone Number: 480-626-6637
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
        • Principal Investigator:
          • Areena Swarup
        • Contact:
          • Phone Number: 480-626-6637
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
        • Principal Investigator:
          • Mona Amin
        • Contact:
          • Phone Number: 602-386-4970
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
        • Principal Investigator:
          • Romy Cabacungan
        • Contact:
          • Phone Number: 520-867-6906
      • Tucson, Arizona, United States, 85748
        • Recruiting
        • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
        • Principal Investigator:
          • Jawad Bilal
        • Contact:
          • Phone Number: 520-849-8753
    • California
      • Apple Valley, California, United States, 92307
        • Recruiting
        • Medvin Clinical Research - Apple Valley
        • Principal Investigator:
          • Diraj Karnani
        • Contact:
          • Phone Number: 909-581-8477
      • Covina, California, United States, 91722
        • Recruiting
        • Medvin Clinical Research - Covina
        • Principal Investigator:
          • Samy Metyas
        • Contact:
          • Phone Number: 626-869-5730
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Newport Huntington Medical Group
        • Contact:
          • Phone Number: 714-378-2440
        • Principal Investigator:
          • Christine Thai
      • La Mesa, California, United States, 91942
        • Recruiting
        • Purushotham & Akther Kotha MD, Inc
        • Principal Investigator:
          • Roshan Kotha
        • Contact:
          • Phone Number: 619-229-1995 x208
      • Riverside, California, United States, 92508
        • Recruiting
        • Medvin Clinical Research - Riverside
        • Principal Investigator:
          • Chandrakant Mehta
        • Contact:
          • Phone Number: 951-672-1866
      • San Diego, California, United States, 92128
        • Recruiting
        • Rheumatology Center of San Diego
        • Principal Investigator:
          • Tania Rivera
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Providence Saint John's Medical Foundation
        • Principal Investigator:
          • Orrin Troum
      • Temecula, California, United States, 92592
        • Recruiting
        • Medvin Clinical Research - Temecula
        • Principal Investigator:
          • Amal Mehta
        • Contact:
          • Phone Number: 951-652-5000
      • Tujunga, California, United States, 91042
        • Recruiting
        • Medvin Clinical Research - Tujunga
        • Contact:
          • Phone Number: 818-265-2250
        • Principal Investigator:
          • Dan La
      • Whittier, California, United States, 90602
        • Recruiting
        • Medvin Clinical Research - Whittier
        • Contact:
          • Phone Number: 562-758-6600
        • Principal Investigator:
          • Tien-I Su
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • Vida Clinical Research
        • Principal Investigator:
          • Nimesh Dayal
      • Margate, Florida, United States, 33063
        • Recruiting
        • LIFE Clinical Trials
        • Principal Investigator:
          • Jigar Shah
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • CZ Rheumatology
        • Principal Investigator:
          • Conrad Ziembinski
      • Palm Beach Gardens, Florida, United States, 33410
        • Recruiting
        • Vitalia Medical Research
        • Principal Investigator:
          • Clifford Stermer
        • Contact:
          • Phone Number: 561-559-1110
      • Tampa, Florida, United States, 33614
        • Recruiting
        • International Center for Research
        • Principal Investigator:
          • Julio Gonzalez-Paoli, MD
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Atlanta Research Center for Rheumatology
        • Contact:
          • Phone Number: 770-372-3962
        • Principal Investigator:
          • Roel Querubin
      • Waycross, Georgia, United States, 31501
        • Recruiting
        • Satilla Rheumatology & Internal Medicine
        • Contact:
          • Phone Number: 912-548-0710
        • Principal Investigator:
          • CHARLES GALEA
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials - Ravenswood
        • Contact:
          • Phone Number: 773-275-3500
        • Principal Investigator:
          • Manish Jain
      • Schaumburg, Illinois, United States, 60195
        • Recruiting
        • Greater Chicago Specialty Physicians
        • Principal Investigator:
          • Kamran Chaudhary
        • Contact:
          • Phone Number: 847-599-2492
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Arnold Arthritis & Rheumatology
        • Principal Investigator:
          • Erin Arnold
      • Willowbrook, Illinois, United States, 60527
        • Recruiting
        • Willow Rheumatology and Wellness PLLC
        • Contact:
          • Phone Number: 434-962-8466
        • Principal Investigator:
          • Angela Crowley
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Lake Cumberland Rheumatology
        • Principal Investigator:
          • Scott Lewis
        • Contact:
          • Phone Number: 502-495-3665
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Recruiting
        • Accurate Clinical Research, Inc
        • Principal Investigator:
          • Enrique Mendez
        • Contact:
          • Phone Number: 337-312-8018
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Recruiting
        • Klein & Associates, M.D., P.A.
        • Contact:
          • Phone Number: 301-724-4337
        • Principal Investigator:
          • Brandi Haas
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Klein & Associates, M.D., P.A.
        • Contact:
          • Phone Number: 301-791-6680
        • Principal Investigator:
          • Okechukwu Okoye
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Institute of Michigan, LLC
        • Principal Investigator:
          • Amar Majjhoo
    • Montana
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Rheumatology
        • Principal Investigator:
          • Roger Diegel
        • Contact:
          • Phone Number: 406-752-2010
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Principal Investigator:
          • Norman Madsen
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Onsite Clinical Solutions, LLC - Brenner Ave
        • Contact:
          • Phone Number: 800-785-3150
        • Principal Investigator:
          • Rakesh Patel
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research & Consulting, LLC
        • Contact:
          • Phone Number: 440-826-0742
        • Principal Investigator:
          • Isam Diab
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Recruiting
        • Essential Medical Research
        • Principal Investigator:
          • Debbie Gladd Foley
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • West Tennessee Research Institute
        • Contact:
          • Phone Number: 731-633-0145
        • Principal Investigator:
          • Jacob Aelion
      • Murfreesboro, Tennessee, United States, 37128
        • Recruiting
        • AARA Clinical Research - Murfreesboro Medical Clinic
        • Contact:
          • Phone Number: 480-626-6650
        • Principal Investigator:
          • Marcus Owen
    • Texas
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Precision Comprehensive Clinical Research Solutions - Colleyville
        • Principal Investigator:
          • Dhiman Basu
        • Contact:
          • Phone Number: 972-299-8399
      • Fort Worth, Texas, United States, 76109
        • Recruiting
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
        • Principal Investigator:
          • Himabindu Reddy
        • Contact:
          • Phone Number: 817-789-6770
      • Houston, Texas, United States, 77089
        • Recruiting
        • Accurate Clinical Research, Inc
        • Principal Investigator:
          • Philip Waller
        • Contact:
          • Phone Number: 281-481-8557
      • Houston, Texas, United States, 77089
        • Recruiting
        • Research Physicians Network, LLC
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Laila Hassan, MD
      • Irving, Texas, United States, 75039
        • Recruiting
        • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
        • Principal Investigator:
          • Shariq Chudhri,
      • Katy, Texas, United States, 77494
        • Recruiting
        • Biopharma Informatic, LLC
        • Contact:
          • Phone Number: 281-944-3610
        • Principal Investigator:
          • Kiran Farheen, MD
      • The Woodlands, Texas, United States, 77382
        • Recruiting
        • Advanced Rheumatology of Houston - Woodlands
        • Principal Investigator:
          • Tamar Brionez
        • Contact:
          • Phone Number: 936-681-4882
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research - TRA
        • Contact:
          • Phone Number: 281-517-0550
        • Principal Investigator:
          • Shaikh Ali
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Seattle Rheumatology Associates PLLC
        • Principal Investigator:
          • Philip Mease
      • Spokane Valley, Washington, United States, 99216
        • Recruiting
        • Arthritis Northwest, PLLC
        • Principal Investigator:
          • Sean LaSalle

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA.
  • 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, obstructive sleep apnea, or cardiovascular disease).
  • Who have been treated 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 or screening).

Exclusion Criteria:

  • Have currently received ixekizumab for more than 4 months or less than 2 months.
  • Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide).
  • Are currently enrolled in any other clinical study.
  • Have a known hypersensitivity to any component of tirzepatide.
  • Have a personal or family history of medullary thyroid cancer.
  • Have multiple endocrine neoplasia type 2.
  • Have type 1 diabetes mellitus.
  • Have a history of chronic or acute pancreatitis at any time before screening.
  • 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 unawareness within the 6 months before screening.
  • Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Time Frame: 12 Months
The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
12 Months
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Time Frame: 12 Months
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change of Weight from Baseline
Time Frame: Baseline, Month 6 and Baseline, Month 12
Mean percent change of weight from baseline.
Baseline, Month 6 and Baseline, Month 12
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Time Frame: Month 6 and Month 12
Percentage of participants achieving TJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Time Frame: Month 6 and Month 12
Percentage of participants achieving SJC ≤1.
Month 6 and Month 12
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Time Frame: Month 6 and Month 12
Percentage of participants achieving BSA ≤3%.
Month 6 and Month 12
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
Time Frame: Month 6 and Month 12
The PaGADA NRS is an 11-point scale from 0 to 10 that is anchored by 2 verbal descriptors, "very well" and "very poor." Higher scores represent a higher level of disease activity.
Month 6 and Month 12
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
Time Frame: Month 6 and Month 12
The Patient's Assessment of Arthritis Pain is a single-item, patient-reported outcome instrument, used to access the current severity of participants' joint pain in relation to their PsA on a horizontal VAS of 0 to 100 mm. The Patient's Assessment of Arthritis Pain is anchored by 2 verbal descriptors, "no pain" and "as severe as can imagine."
Month 6 and Month 12
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
Time Frame: Month 6 and Month 12
The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."
Month 6 and Month 12
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
Time Frame: Month 6 and Month 12
The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6 and Month 12
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
Time Frame: Month 6 and Month 12
FACIT-F is a patient-reported, 13-item questionnaire that specifically assess the self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses 0 ("not at all") to 4 ("very much") Likert scale to assess fatigue and its impact in the past 7 days. Total score ranges from 0 to 52, based on a rating of 5-point Likert scale. Scores for negatively worded items are reversed, such that higher scores are better (that is, less fatigue).
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
Time Frame: Month 6 and Month 12
The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
Time Frame: Month 6 and Month 12
The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Month 6 and Month 12
Percentage of Participants Achieving a HAQ-DI score ≤0.5
Time Frame: Month 6
The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Month 6
Percentage of Participants with ≥10% Weight Loss at Month 6
Time Frame: Month 6
Percentage of participants with ≥10% weight loss at month 6.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27350
  • I1F-MC-RHDE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan Description: 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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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