TOGETHER AMPLIFY-PsA: Tirzepatide for Psoriatic Arthritis and Overweight/Obesity

This study is looking at how effective tirzepatide is when added to ixekizumab for people with active psoriatic arthritis (PsA) who are also overweight or have obesity. Tirzepatide is given as an injection under the skin. To join, you need to have active PsA and a Body Mass Index (BMI) of 27 or higher, along with at least one weight-related health issue. The study will measure if participants achieve better daily functioning (HAQ-DI score of 0.5 or less) and at least 10% weight loss after 12 months. This study plans to enroll 200 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 200 participants. The phase of the study is not specified.
What's involved
The study will last up to 12 months. You will receive tirzepatide administered as an injection under the skin.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 12 months of therapy.

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NCT06864026

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)

Recruiting
PHASE4Ages 18+InterventionalTreatment
Eli Lilly and Company
~200 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
55 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Measured over 12 Months
+1 more outcome measured
Psoriatic Arthritis
Overweight or Obesity
55 sites across 18 states
Arizona10
California10
Texas8
Florida5
Illinois4
Georgia2
Maryland2
Tennessee2
  • 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
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Eligibility criteria

Inclusion

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

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.
  • Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy12 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.

  • Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy12 Months

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