NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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)

NCT06864026

RecruitingPhase 4

Sponsor: Eli Lilly and Company

Conditions: Psoriatic Arthritis, Overweight or Obesity

Interventions: Tirzepatide

Countries: United States, Puerto Rico

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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) 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.

Locations (55)

Avondale, Arizona, United States
Chandler, Arizona, United States
Flagstaff, Arizona, United States
Gilbert, Arizona, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Apple Valley, California, United States
Covina, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
Riverside, California, United States
San Diego, California, United States
Santa Monica, California, United States
Temecula, California, United States
Tujunga, California, United States
Whittier, California, United States
Kissimmee, Florida, United States
Margate, Florida, United States
Miami Beach, Florida, United States
Palm Beach Gardens, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Waycross, Georgia, United States
Chicago, Illinois, United States
Schaumburg, Illinois, United States
Skokie, Illinois, United States
+ 25 more on CT.gov