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Psoriatic ArthritisPhase 4NCT06864026

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)

A Phase 4 study testing Tirzepatide in people with Psoriatic Arthritis and Overweight or Obesity, run by Eli Lilly and Company at 55 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 active PsA 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
Psoriatic Arthritis, 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
55 sitesin 2 countries
Study dates
6 Mar 2025to Aug 2027
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 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

United States53 sites

  • Medvin Clinical Research - Apple Valley

    Apple Valley, California, 92307

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

    Avondale, Arizona, 85392

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

    Chandler, Arizona, 85225

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

  • Precision Comprehensive Clinical Research Solutions - Colleyville

    Colleyville, Texas, 76034

  • Medvin Clinical Research - Covina

    Covina, California, 91722

  • Klein & Associates, M.D., P.A.

    Cumberland, Maryland, 21502

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

    Flagstaff, Arizona, 86001

  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth

    Fort Worth, Texas, 76109

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

    Gilbert, Arizona, 85297

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

    Glendale, Arizona, 85306

  • Klein & Associates, M.D., P.A.

    Hagerstown, Maryland, 21740

  • Accurate Clinical Research, Inc

    Houston, Texas, 77089

  • Research Physicians Network, LLC

    Houston, Texas, 77089

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648

  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving

    Irving, Texas, 75039

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Logan Health Rheumatology

    Kalispell, Montana, 59901

  • Biopharma Informatic, LLC

    Katy, Texas, 77494

  • Vida Clinical Research

    Kissimmee, Florida, 34741

  • Purushotham & Akther Kotha MD, Inc

    La Mesa, California, 91942

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana, 70605

  • Life Clinical Trials

    Margate, Florida, 33063

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

    Mesa, Arizona, 85210

  • CZ Rheumatology

    Miami Beach, Florida, 33140

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • AARA Clinical Research - Murfreesboro Medical Clinic

    Murfreesboro, Tennessee, 37128

  • Lake Cumberland Rheumatology

    New Albany, Indiana, 47150

  • Vitalia Medical Research

    Palm Beach Gardens, Florida, 33410

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

    Phoenix, Arizona, 85032

  • Medvin Clinical Research - Riverside

    Riverside, California, 92508

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081

  • Onsite Clinical Solutions, LLC - Brenner Ave

    Salisbury, North Carolina, 28144

  • Rheumatology Center of San Diego

    San Diego, California, 92128

  • Providence Saint John's Medical Foundation

    Santa Monica, California, 90404

  • Greater Chicago Specialty Physicians

    Schaumburg, Illinois, 60195

  • Seattle Rheumatology Associates PLLC

    Seattle, Washington, 98104

  • Arnold Arthritis & Rheumatology

    Skokie, Illinois, 60076

  • Arthritis Northwest, PLLC

    Spokane Valley, Washington, 99216

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

    Sun City, Arizona, 85351

  • International Center for Research

    Tampa, Florida, 33614

  • Medvin Clinical Research - Temecula

    Temecula, California, 92592

  • Advanced Rheumatology of Houston - Woodlands

    The Woodlands, Texas, 77382

  • DM Clinical Research - TRA

    Tomball, Texas, 77375

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

    Tucson, Arizona, 85704

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

    Tucson, Arizona, 85748

  • Medvin Clinical Research - Tujunga

    Tujunga, California, 91042

  • Essential Medical Research

    Tulsa, Oklahoma, 74137

  • Satilla Rheumatology & Internal Medicine

    Waycross, Georgia, 31501

  • Medvin Clinical Research - Whittier

    Whittier, California, 90602

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

Other trials in United States

Puerto Rico2 sites

  • Reuviva Research Center

    Guaynabo, 00968

  • CMRC Headlands, LLC

    San Juan, 00918

Other trials in Puerto Rico

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 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 active PsA 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
Arthritis, Psoriatic, Overweight, Obesity

What participants receive

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

Study groups in NCT06864026
Study groupRoleWhat they receive
TirzepatideExperimentalParticipants will continue on ixekizumab and take tirzepatide administered 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 Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy

    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.

    Measured: 12 Months

  2. Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy

    Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.

    Measured: 12 Months

Secondary outcomes (13)

  1. Percentage of Participants Achieving Tender Joint Count (TJC) ≤1

    Percentage of participants achieving TJC ≤1.

    Measured: Month 6 and Month 12

  2. Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1

    Percentage of participants achieving SJC ≤1.

    Measured: Month 6 and Month 12

  3. Percentage of Participants Achieving Body Surface Area (BSA) ≤3%

    Percentage of participants achieving BSA ≤3%.

    Measured: Month 6 and Month 12

  4. Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2

    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.

    Measured: Month 6 and Month 12

  5. Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15

    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."

    Measured: Month 6 and Month 12

  6. Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2

    The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."

    Measured: Month 6 and Month 12

  7. Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss

    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.

    Measured: Month 6 and Month 12

  8. Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline

    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).

    Measured: Month 6 and Month 12

  9. Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)

    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.

    Measured: Month 6 and Month 12

  10. Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID

    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.

    Measured: Month 6 and Month 12

  11. Percentage of Participants Achieving a HAQ-DI score ≤0.5

    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.

    Measured: Month 6

  12. Percentage of Participants with ≥10% Weight Loss at Month 6

    Percentage of participants with ≥10% weight loss at month 6.

    Measured: Month 6

  13. Mean Percent Change of Weight from Baseline

    Mean percent change of weight from baseline.

    Measured: Baseline, Month 6 and Baseline, 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 posted7 Mar 2025
  2. Study start6 Mar 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (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
NCT06864026
Sponsor's protocol ID
27350
Other IDs
I1F-MC-RHDE
Status last verified
Sep 2026
First submitted
3 Mar 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tirzepatide in people with Psoriatic Arthritis and Overweight or Obesity, run by Eli Lilly and Company at 55 sites in 2 countries.

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 12 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Puerto Rico. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 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 NCT06864026.

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 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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