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Zepbound ® (tirzepatide) injection
2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 12.5 mg/ 15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What data are available for the TOGETHER AMPLIFY-PsA study conducted in adult participants with active psoriatic arthritis and obesity or overweight?
TOGETHER AMPLIFY-PsA is a phase 4 study assessing the effectiveness of tirzepatide following initiation of ixekizumab.
See important safety information, including boxed warning, in the attached prescribing information.
TOGETHER AMPLIFY-PsA Study
Study Design Overview
TOGETHER AMPLIFY-PsA (NCT06864026) is a phase 4 study designed to assess the effectiveness of tirzepatide following initiation of ixekizumab in adult participants with active psoriatic arthritis and overweight or obesity in clinical practice.1,2
This prospective, open-label, single-arm study will include the FDA-approved doses of ixekizumab and tirzepatide for 12 months of treatment with the primary endpoint assessment at 12 months.1,2
Inclusion Criteria
Patients enrolled in TOGETHER AMPLIFY-PsA study must
- be ≥18 years of age
- have a diagnosis of active psoriatic arthritis
- have BMI of ≥30 kg/m2 (obesity) or 27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular diseases)
- have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide, and
- be able to initiate tirzepatide (day 0) within 30 days of treatment decision (baseline/screening).1
Exclusion Criteria
Patients will be excluded from the TOGETHER AMPLIFY-PsA study if they
- have currently received ixekizumab for more than 4 months or less than 2 months
- had any exposure to tirzepatide or other GLP-1 RAs (eg, 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 (MTZ)
- have multiple endocrine neoplasia type 2 (MEN 2)
- have type 1 diabetes (T1D)
- 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, or
- have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.1
Primary Objectives
The primary objectives of the TOGETHER AMPLIFY-PsA study are to assess the percentage of participants achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 months of therapy, and at least a 10% weight loss at 12 months.1
Secondary Objectives
The secondary objectives will be assessed at months 6 and 12 that include the percentage of participants
- achieving tender joint count ≤1
- achieving swollen joint count ≤1
- achieving body surface area ≤3%
- achieving Patient Global Assessment of Disease Activity Numeric Rating Score of ≤2
- achieving Patient Pain Visual Analogue Scale ≤15
- achieving Physician Global Assessment of Disease Activity ≤2
- achieving HAQ-DI score ≤0.5 and at least a 10% weight loss
- with a Functional Assessment of Chronic Illness Therapy - Fatigue With ≥4-point increase from baseline
- with a Short-Form 36 (SF36) Physical Component Score Minimum Clinically Important Difference (MCID)
- with a SF36 Mental Component Score MCID
- achieving a HAQ-DI score ≤0.5 at month 6
- with ≥10% weight loss at month 6, and
- mean percent change of weight from baseline.1
TOGETHER AMPLIFY-PsA Completion Timeline
The study started in March 2025. Please refer to https://clinicaltrials.gov/study/NCT06864026 for the most up-to-date information.1
Contraindications
There are no known contraindications for the concomitant use of ixekizumab with tirzepatide.2
Drug-Drug Interactions
No drug-drug interaction studies have been conducted between ixekizumab and tirzepatide.2
Enclosed Prescribing Information
References
1A 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). ClinicalTrials.gov identifier: NCT06864026. Updated December 24, 2025. Accessed January 12, 2026. https://clinicaltrials.gov/study/NCT06864026
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: January 12, 2026