Tirzepatide for Obese Patients with Psoriatic Arthritis
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
Phase 4Interventional Study
Psoriatic ArthritisOverweight or Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for people with active psoriatic arthritis who are overweight or obese. Participants will add a medication called tirzepatide to their current treatment with ixekizumab for up to 12 months.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesMedullary thyroid cancerMultiple endocrine neoplasia type 2Pancreatitis
You may be able to join if
I have been diagnosed with active psoriatic arthritis.
I have a Body Mass Index of 27 or higher.
I have been treated with ixekizumab for about 3 months.
I have at least one weight-related health issue.
I can start tirzepatide within 30 days after the decision.
You may not be able to join if
I have been on ixekizumab for more than 4 months.
I have been on ixekizumab for less than 2 months.
I have used tirzepatide or other similar medications before.
I have a known allergy to tirzepatide.
I have a family history of medullary thyroid cancer.
I have a history of pancreatitis.
I have a history of severe hypoglycemia unawareness.
I have a history of severe gastrointestinal problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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)…
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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