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 Genders
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 - Flagstaff
Flagstaff, Arizona 86001
Contact:
602-926-9753

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert, Arizona 85297
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 - Sun City
Sun City, Arizona 85351
Contact:
602-386-4970

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

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

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

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

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

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

Rheumatology Center of San Diego
San Diego, California 92128

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

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

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

Vida Clinical Research
Kissimmee, Florida 34741

Life Clinical Trials
Margate, Florida 33063

CZ Rheumatology
Miami Beach, Florida 33140

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

International Center for Research
Tampa, Florida 33614

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

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

Arnold Arthritis & Rheumatology
Skokie, Illinois 60076

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

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

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

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

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

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

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

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

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

Essential Medical Research
Tulsa, Oklahoma 74137

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

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

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

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

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

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

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

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

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

Seattle Rheumatology Associates PLLC
Seattle, Washington 98104

Arthritis Northwest, PLLC
Spokane, Washington 99204

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

Caribbean Medical Research Center
San Juan, Puerto Rico 00918

More Details

NCT ID
NCT06864026
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
3176154559
clinical_inquiry_hub@lilly.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center