RECRUITING

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)

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Conditions

Psoriatic ArthritisOverweight or Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice.

Quick Facts

Study Start:2025-03-06
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06864026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA.
  2. * 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).
  3. * Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide.
  4. * Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).
  1. * Have currently received ixekizumab for more than 4 months or less than 2 months.
  2. * Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide).
  3. * Are currently enrolled in any other clinical study.
  4. * Have a known hypersensitivity to any component of tirzepatide.
  5. * Have a personal or family history of medullary thyroid cancer.
  6. * Have multiple endocrine neoplasia type 2.
  7. * Have type 1 diabetes mellitus.
  8. * Have a history of chronic or acute pancreatitis at any time before screening.
  9. * Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
  10. * Have a history of ketoacidosis or hyperosmolar state/coma.
  11. * Have a history of severe hypoglycemia unawareness within the 6 months before screening.
  12. * Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.

Contacts and Locations

Study Contact

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

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale, Arizona, 85392
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler, Arizona, 85225
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff, Arizona, 86001
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert, Arizona, 85297
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, 85306
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa, Arizona, 85210
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix, Arizona, 85032
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City, Arizona, 85351
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
Tucson, Arizona, 85704
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson, Arizona, 85748
United States
Medvin Clinical Research - Apple Valley
Apple Valley, California, 92307
United States
Medvin Clinical Research - Covina
Covina, California, 91722
United States
Newport Huntington Medical Group
Huntington Beach, California, 92648
United States
Purushotham & Akther Kotha MD, Inc
La Mesa, California, 91942
United States
Medvin Clinical Research - Riverside
Riverside, California, 92508
United States
Rheumatology Center of San Diego
San Diego, California, 92128
United States
Providence Saint John's Medical Foundation
Santa Monica, California, 90404
United States
Medvin Clinical Research - Temecula
Temecula, California, 92592
United States
Medvin Clinical Research - Tujunga
Tujunga, California, 91042
United States
Medvin Clinical Research - Whittier
Whittier, California, 90602
United States
CZ Rheumatology
Coral Springs, Florida, 33065
United States
Life Clinical Trials
Margate, Florida, 33063
United States
Advanced Clinical Research of Orlando - Ocoee
Ocoee, Florida, 34761
United States
Vitalia Medical Research
Palm Beach Gardens, Florida, 33410
United States
International Center for Research
Tampa, Florida, 33614
United States
Conquest Research
Winter Park, Florida, 32789
United States
Atlanta Research Center for Rheumatology
Marietta, Georgia, 30060
United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
United States
Greater Chicago Specialty Physicians
Schaumburg, Illinois, 60195
United States
Arnold Arthritis & Rheumatology
Skokie, Illinois, 60076
United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, 60527
United States
Lake Cumberland Rheumatology
New Albany, Indiana, 47150
United States
Accurate Clinical Research, Inc
Lake Charles, Louisiana, 70605
United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, 21502
United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740
United States
Logan Health Rheumatology
Kalispell, Montana, 59901
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Onsite Clinical Solutions, LLC - Brenner Ave
Salisbury, North Carolina, 28144
United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
United States
Essential Medical Research
Tulsa, Oklahoma, 74137
United States
West Tennessee Research Institute
Jackson, Tennessee, 38305
United States
AARA Clinical Research - Murfreesboro Medical Clinic
Murfreesboro, Tennessee, 37128
United States
Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville, Texas, 76034
United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
Fort Worth, Texas, 76109
United States
Accurate Clinical Research, Inc
Houston, Texas, 77089
United States
Research Physicians Network, LLC
Houston, Texas, 77089
United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
Irving, Texas, 75039
United States
Biopharma Informatic, LLC
Katy, Texas, 77494
United States
SouthWest Rheumatology Research, LLC
Mesquite, Texas, 75150
United States
Advanced Rheumatology of Houston - Woodlands
The Woodlands, Texas, 77382
United States
DM Clinical Research - TRA
Tomball, Texas, 77375
United States
Seattle Rheumatology Associates PLLC
Seattle, Washington, 98104
United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-06
Study Completion Date2027-01

Study Record Updates

Study Start Date2025-03-06
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Psoriatic Arthritis
  • Overweight or Obesity