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)

Purpose

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.

Conditions

  • Psoriatic Arthritis
  • Overweight or Obesity

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide 		Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176

Recruiting Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona 85392
Contact:
602-386-4971

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler, Arizona 85225
Contact:
480-443-8400

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix, Arizona 85032
Contact:
480-626-6637

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson, Arizona 85748
Contact:
520-849-8753

Medvin Clinical Research - Tujunga
Tujunga, California 91042
Contact:
818-265-2250

Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville, Texas 76034
Contact:
972-299-8399

Accurate Clinical Research, Inc
Houston, Texas 77089
Contact:
281-481-8557

DM Clinical Research - TRA
Tomball, Texas 77375
Contact:
281-517-0550

CMRC Headlands, LLC
San Juan, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com