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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)

RECRUITINGPhase 4Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 4
SponsorEli Lilly and Company
Started2025-03-06
Est. completion2027-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations53 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

ArthritisOverweight or ObesityPsoriatic Arthritis

Interventions1

Locations53 sites

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, 85392
602-386-4971
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler, Arizona, 85225
480-443-8400
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona, 86001
928-666-3772
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert, Arizona, 85297
480-443-8400
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, 85306
602-386-4969

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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