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)

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06864026
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis, Overweight or Obesity
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Tirzepatide

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

Interventions

Drug: - Tirzepatide

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Avondale, Arizona

Status

Not yet recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, 85392

Chandler, Arizona

Status

Not yet recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, 85225

Flagstaff, Arizona

Status

Not yet recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, 86001

Gilbert, Arizona

Status

Not yet recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, 85297

Glendale, Arizona

Status

Not yet recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, 85306

Mesa, Arizona

Status

Not yet recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, 85210

Phoenix, Arizona

Status

Not yet recruiting

Address

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

Phoenix, Arizona, 85032

Sun City, Arizona

Status

Not yet recruiting

Address

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

Sun City, Arizona, 85351

Tucson, Arizona

Status

Not yet recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona, 85704

Tucson, Arizona

Status

Not yet recruiting

Address

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

Tucson, Arizona, 85748

Medvin Clinical Research - Apple Valley, Apple Valley, California

Status

Recruiting

Address

Medvin Clinical Research - Apple Valley

Apple Valley, California, 92307

Medvin Clinical Research - Covina, Covina, California

Status

Recruiting

Address

Medvin Clinical Research - Covina

Covina, California, 91722

Newport Huntington Medical Group, Huntington Beach, California

Status

Not yet recruiting

Address

Newport Huntington Medical Group

Huntington Beach, California, 92648

Purushotham & Akther Kotha MD, Inc, La Mesa, California

Status

Not yet recruiting

Address

Purushotham & Akther Kotha MD, Inc

La Mesa, California, 91942

Medvin Clinical Research - Riverside, Riverside, California

Status

Not yet recruiting

Address

Medvin Clinical Research - Riverside

Riverside, California, 92508

Rheumatology Center of San Diego, San Diego, California

Status

Not yet recruiting

Address

Rheumatology Center of San Diego

San Diego, California, 92128

Santa Monica, California

Status

Not yet recruiting

Address

Providence Saint John's Medical Foundation

Santa Monica, California, 90404

Medvin Clinical Research - Temecula, Temecula, California

Status

Not yet recruiting

Address

Medvin Clinical Research - Temecula

Temecula, California, 92592

Medvin Clinical Research - Tujunga, Tujunga, California

Status

Recruiting

Address

Medvin Clinical Research - Tujunga

Tujunga, California, 91042

Medvin Clinical Research - Whittier, Whittier, California

Status

Recruiting

Address

Medvin Clinical Research - Whittier

Whittier, California, 90602

CZ Rheumatology, Coral Springs, Florida

Status

Not yet recruiting

Address

CZ Rheumatology

Coral Springs, Florida, 33065

Life Clinical Trials, Margate, Florida

Status

Not yet recruiting

Address

Life Clinical Trials

Margate, Florida, 33063

Ocoee, Florida

Status

Not yet recruiting

Address

Advanced Clinical Research of Orlando - Ocoee

Ocoee, Florida, 34761

Vitalia Medical Research, Palm Beach Gardens, Florida

Status

Recruiting

Address

Vitalia Medical Research

Palm Beach Gardens, Florida, 33410

International Center for Research, Tampa, Florida

Status

Not yet recruiting

Address

International Center for Research

Tampa, Florida, 33614

Conquest Research, Winter Park, Florida

Status

Not yet recruiting

Address

Conquest Research

Winter Park, Florida, 32789

Atlanta Research Center for Rheumatology, Marietta, Georgia

Status

Not yet recruiting

Address

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060

Great Lakes Clinical Trials - Ravenswood, Chicago, Illinois

Status

Not yet recruiting

Address

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640

Greater Chicago Specialty Physicians, Schaumburg, Illinois

Status

Not yet recruiting

Address

Greater Chicago Specialty Physicians

Schaumburg, Illinois, 60195

Arnold Arthritis & Rheumatology, Skokie, Illinois

Status

Recruiting

Address

Arnold Arthritis & Rheumatology

Skokie, Illinois, 60076

Willow Rheumatology and Wellness PLLC, Willowbrook, Illinois

Status

Recruiting

Address

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, 60527

Lake Cumberland Rheumatology, New Albany, Indiana

Status

Recruiting

Address

Lake Cumberland Rheumatology

New Albany, Indiana, 47150

Accurate Clinical Research, Inc, Lake Charles, Louisiana

Status

Not yet recruiting

Address

Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605

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

Status

Recruiting

Address

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

Cumberland, Maryland, 21502

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

Status

Recruiting

Address

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

Hagerstown, Maryland, 21740

Logan Health Rheumatology, Kalispell, Montana

Status

Not yet recruiting

Address

Logan Health Rheumatology

Kalispell, Montana, 59901

University of Rochester Medical Center, Rochester, New York

Status

Not yet recruiting

Address

University of Rochester Medical Center

Rochester, New York, 14642

Salisbury, North Carolina

Status

Not yet recruiting

Address

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury, North Carolina, 28144

Middleburg Heights, Ohio

Status

Not yet recruiting

Address

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, 44130

Essential Medical Research, Tulsa, Oklahoma

Status

Not yet recruiting

Address

Essential Medical Research

Tulsa, Oklahoma, 74137

West Tennessee Research Institute, Jackson, Tennessee

Status

Recruiting

Address

West Tennessee Research Institute

Jackson, Tennessee, 38305

Murfreesboro, Tennessee

Status

Not yet recruiting

Address

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee, 37128

Colleyville, Texas

Status

Not yet recruiting

Address

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville, Texas, 76034

Fort Worth, Texas

Status

Not yet recruiting

Address

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

Fort Worth, Texas, 76109

Accurate Clinical Research, Inc, Houston, Texas

Status

Not yet recruiting

Address

Accurate Clinical Research, Inc

Houston, Texas, 77089

Research Physicians Network, LLC, Houston, Texas

Status

Recruiting

Address

Research Physicians Network, LLC

Houston, Texas, 77089

Irving, Texas

Status

Not yet recruiting

Address

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

Irving, Texas, 75039

Biopharma Informatic, LLC, Katy, Texas

Status

Recruiting

Address

Biopharma Informatic, LLC

Katy, Texas, 77494

SouthWest Rheumatology Research, LLC, Mesquite, Texas

Status

Not yet recruiting

Address

SouthWest Rheumatology Research, LLC

Mesquite, Texas, 75150

The Woodlands, Texas

Status

Recruiting

Address

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, 77382

DM Clinical Research - TRA, Tomball, Texas

Status

Recruiting

Address

DM Clinical Research - TRA

Tomball, Texas, 77375

Seattle Rheumatology Associates PLLC, Seattle, Washington

Status

Not yet recruiting

Address

Seattle Rheumatology Associates PLLC

Seattle, Washington, 98104

Arthritis Northwest, PLLC, Spokane, Washington

Status

Not yet recruiting

Address

Arthritis Northwest, PLLC

Spokane, Washington, 99204

International Sites

Reuviva Research Center, Guaynabo, Puerto Rico

Status

Recruiting

Address

Reuviva Research Center

Guaynabo, , 00969

Caribbean Medical Research Center, San Juan, Puerto Rico

Status

Recruiting

Address

Caribbean Medical Research Center

San Juan, , 00918