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 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 27350I1F-MC-RHDE
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 55

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy

  The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.

  12 Months

• Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy

  Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.

  12 Months

Secondary Outcomes (13)

• Percentage of Participants Achieving Tender Joint Count (TJC) ≤1

  Month 6 and Month 12

• Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1

  Month 6 and Month 12

• Percentage of Participants Achieving Body Surface Area (BSA) ≤3%

  Month 6 and Month 12

• Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2

  Month 6 and Month 12

• Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15

  Month 6 and Month 12

Study Arms (1)

Tirzepatide

EXPERIMENTAL

Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

Tirzepatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (55)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, 85392, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, 85225, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, 86001, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, 85297, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, 85306, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, 85210, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

Phoenix, Arizona, 85032, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

Sun City, Arizona, 85351, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona, 85704, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

Tucson, Arizona, 85748, United States

RECRUITING

Medvin Clinical Research - Apple Valley

Apple Valley, California, 92307, United States

RECRUITING

Medvin Clinical Research - Covina

Covina, California, 91722, United States

RECRUITING

Newport Huntington Medical Group

Huntington Beach, California, 92648, United States

RECRUITING

Purushotham & Akther Kotha MD, Inc

La Mesa, California, 91942, United States

RECRUITING

Medvin Clinical Research - Riverside

Riverside, California, 92508, United States

RECRUITING

Rheumatology Center of San Diego

San Diego, California, 92128, United States

RECRUITING

Providence Saint John's Medical Foundation

Santa Monica, California, 90404, United States

RECRUITING

Medvin Clinical Research - Temecula

Temecula, California, 92592, United States

RECRUITING

Medvin Clinical Research - Tujunga

Tujunga, California, 91042, United States

RECRUITING

Medvin Clinical Research - Whittier

Whittier, California, 90602, United States

RECRUITING

Vida Clinical Research

Kissimmee, Florida, 34741, United States

RECRUITING

Life Clinical Trials

Margate, Florida, 33063, United States

RECRUITING

CZ Rheumatology

Miami Beach, Florida, 33140, United States

RECRUITING

Vitalia Medical Research

Palm Beach Gardens, Florida, 33410, United States

RECRUITING

International Center for Research

Tampa, Florida, 33614, United States

RECRUITING

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060, United States

RECRUITING

Satilla Rheumatology & Internal Medicine

Waycross, Georgia, 31501, United States

RECRUITING

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640, United States

RECRUITING

Greater Chicago Specialty Physicians

Schaumburg, Illinois, 60195, United States

RECRUITING

Arnold Arthritis & Rheumatology

Skokie, Illinois, 60076, United States

RECRUITING

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, 60527, United States

RECRUITING

Lake Cumberland Rheumatology

New Albany, Indiana, 47150, United States

RECRUITING

Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605, United States

RECRUITING

Klein & Associates, M.D., P.A.

Cumberland, Maryland, 21502, United States

RECRUITING

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, 21740, United States

RECRUITING

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, 48081, United States

RECRUITING

Logan Health Rheumatology

Kalispell, Montana, 59901, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury, North Carolina, 28144, United States

RECRUITING

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

RECRUITING

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

RECRUITING

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee, 37128, United States

RECRUITING

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville, Texas, 76034, United States

RECRUITING

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth

Fort Worth, Texas, 76109, United States

RECRUITING

Accurate Clinical Research, Inc

Houston, Texas, 77089, United States

RECRUITING

Research Physicians Network, LLC

Houston, Texas, 77089, United States

RECRUITING

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving

Irving, Texas, 75039, United States

RECRUITING

Biopharma Informatic, LLC

Katy, Texas, 77494, United States

RECRUITING

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, 77382, United States

RECRUITING

DM Clinical Research - TRA

Tomball, Texas, 77375, United States

RECRUITING

Seattle Rheumatology Associates PLLC

Seattle, Washington, 98104, United States

RECRUITING

Arthritis Northwest, PLLC

Spokane Valley, Washington, 99216, United States

RECRUITING

Reuviva Research Center

Guaynabo, 00968, Puerto Rico

RECRUITING

CMRC Headlands, LLC

San Juan, 00918, Puerto Rico

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Psoriatic; Overweight; Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: March 6, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (53); PR (2)