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 moderate-to-severe 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 5552301, Arizona 5551752 85392
Contact:
602-386-4971

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler 5289282, Arizona 5551752 85225
Contact:
480-443-8400

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff 5294810, Arizona 5551752 86001
Contact:
928-666-3772

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert 5295903, Arizona 5551752 85297
Contact:
480-443-8400

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale 5295985, Arizona 5551752 85306
Contact:
602-386-4969

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa 5304391, Arizona 5551752 85210
Contact:
480-626-6637

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix 5308655, Arizona 5551752 85032
Contact:
480-626-6637

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City 5316201, Arizona 5551752 85351
Contact:
602-386-4970

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
Tucson 5318313, Arizona 5551752 85704
Contact:
520-867-6906

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson 5318313, Arizona 5551752 85748
Contact:
520-849-8753

Medvin Clinical Research - Apple Valley
Apple Valley 5324363, California 5332921 92307
Contact:
909-581-8477

Medvin Clinical Research - Covina
Covina 5340175, California 5332921 91722
Contact:
626-869-5730

Newport Huntington Medical Group
Huntington Beach 5358705, California 5332921 92648
Contact:
714-378-2440

Purushotham & Akther Kotha MD, Inc
La Mesa 5363990, California 5332921 91942
Contact:
619-229-1995 x208

Medvin Clinical Research - Riverside
Riverside 5387877, California 5332921 92508
Contact:
951-672-1866

Rheumatology Center of San Diego
San Diego 5391811, California 5332921 92128

Providence Saint John's Medical Foundation
Santa Monica 5393212, California 5332921 90404

Medvin Clinical Research - Temecula
Temecula 5401395, California 5332921 92592
Contact:
951-652-5000

Medvin Clinical Research - Tujunga
Tujunga 5403767, California 5332921 91042
Contact:
818-265-2250

Medvin Clinical Research - Whittier
Whittier 5409059, California 5332921 90602
Contact:
562-758-6600

Vida Clinical Research
Kissimmee 4160983, Florida 4155751 34741

Life Clinical Trials
Margate 4163407, Florida 4155751 33063

CZ Rheumatology
Miami Beach 4164143, Florida 4155751 33140

Vitalia Medical Research
Palm Beach Gardens 4167519, Florida 4155751 33410
Contact:
561-559-1110

International Center for Research
Tampa 4174757, Florida 4155751 33614

Atlanta Research Center for Rheumatology
Marietta 4207783, Georgia 4197000 30060
Contact:
770-372-3962

Satilla Rheumatology & Internal Medicine
Waycross 4229763, Georgia 4197000 31501
Contact:
912-548-0710

Great Lakes Clinical Trials - Ravenswood
Chicago 4887398, Illinois 4896861 60640
Contact:
773-275-3500

Greater Chicago Specialty Physicians
Schaumburg 4910713, Illinois 4896861 60195
Contact:
847-599-2492

Arnold Arthritis & Rheumatology
Skokie 4911600, Illinois 4896861 60076

Willow Rheumatology and Wellness PLLC
Willowbrook 4916709, Illinois 4896861 60527
Contact:
434-962-8466

Lake Cumberland Rheumatology
New Albany 4262045, Indiana 4921868 47150
Contact:
502-495-3665

Accurate Clinical Research, Inc
Lake Charles 4330236, Louisiana 4331987 70605
Contact:
337-312-8018

Klein & Associates, M.D., P.A.
Cumberland 4352681, Maryland 4361885 21502
Contact:
301-724-4337

Klein & Associates, M.D., P.A.
Hagerstown 4357141, Maryland 4361885 21740
Contact:
301-791-6680

Clinical Research Institute of Michigan, LLC
Saint Clair Shores 5010978, Michigan 5001836 48081

Logan Health Rheumatology
Kalispell 5660340, Montana 5667009 59901
Contact:
406-752-2010

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642

Onsite Clinical Solutions, LLC - Brenner Ave
Salisbury 4489985, North Carolina 4482348 28144
Contact:
800-785-3150

Paramount Medical Research & Consulting, LLC
Middleburg Heights 5162851, Ohio 5165418 44130
Contact:
440-826-0742

Essential Medical Research
Tulsa 4553433, Oklahoma 4544379 74137

West Tennessee Research Institute
Jackson 4632595, Tennessee 4662168 38305
Contact:
731-633-0145

AARA Clinical Research - Murfreesboro Medical Clinic
Murfreesboro 4644312, Tennessee 4662168 37128
Contact:
480-626-6650

Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville 4682478, Texas 4736286 76034
Contact:
972-299-8399

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
Fort Worth 4691930, Texas 4736286 76109
Contact:
817-789-6770

Accurate Clinical Research, Inc
Houston 4699066, Texas 4736286 77089
Contact:
281-481-8557

Research Physicians Network, LLC
Houston 4699066, Texas 4736286 77089
Contact:
281-944-3610

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
Irving 4700168, Texas 4736286 75039

Biopharma Informatic, LLC
Katy 4702732, Texas 4736286 77494
Contact:
281-944-3610

Advanced Rheumatology of Houston - Woodlands
The Woodlands 4736476, Texas 4736286 77382
Contact:
936-681-4882

DM Clinical Research - TRA
Tomball 4737094, Texas 4736286 77375
Contact:
281-517-0550

Seattle Rheumatology Associates PLLC
Seattle 5809844, Washington 5815135 98104

Arthritis Northwest, PLLC
Spokane Valley 5811729, Washington 5815135 99216

Reuviva Research Center
Guaynabo 4565119, Puerto Rico 00968
Contact:
939-599-0382

CMRC Headlands, LLC
San Juan 4568127, 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