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 5552301, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale 5552301, Arizona 5551752, 85392

Chandler 5289282, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler 5289282, Arizona 5551752, 85225

Flagstaff 5294810, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff 5294810, Arizona 5551752, 86001

Gilbert 5295903, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert 5295903, Arizona 5551752, 85297

Glendale 5295985, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale 5295985, Arizona 5551752, 85306

Mesa 5304391, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa 5304391, Arizona 5551752, 85210

Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

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

Phoenix 5308655, Arizona 5551752, 85032

Sun City 5316201, Arizona 5551752

Status

Recruiting

Address

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

Sun City 5316201, Arizona 5551752, 85351

Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson 5318313, Arizona 5551752, 85704

Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

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

Tucson 5318313, Arizona 5551752, 85748

Medvin Clinical Research - Apple Valley, Apple Valley 5324363, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Apple Valley

Apple Valley 5324363, California 5332921, 92307

Medvin Clinical Research - Covina, Covina 5340175, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Covina

Covina 5340175, California 5332921, 91722

Newport Huntington Medical Group, Huntington Beach 5358705, California 5332921

Status

Recruiting

Address

Newport Huntington Medical Group

Huntington Beach 5358705, California 5332921, 92648

Purushotham & Akther Kotha MD, Inc, La Mesa 5363990, California 5332921

Status

Recruiting

Address

Purushotham & Akther Kotha MD, Inc

La Mesa 5363990, California 5332921, 91942

Medvin Clinical Research - Riverside, Riverside 5387877, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Riverside

Riverside 5387877, California 5332921, 92508

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

Status

Recruiting

Address

Rheumatology Center of San Diego

San Diego 5391811, California 5332921, 92128

Santa Monica 5393212, California 5332921

Status

Not yet recruiting

Address

Providence Saint John's Medical Foundation

Santa Monica 5393212, California 5332921, 90404

Medvin Clinical Research - Temecula, Temecula 5401395, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Temecula

Temecula 5401395, California 5332921, 92592

Medvin Clinical Research - Tujunga, Tujunga 5403767, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Tujunga

Tujunga 5403767, California 5332921, 91042

Medvin Clinical Research - Whittier, Whittier 5409059, California 5332921

Status

Recruiting

Address

Medvin Clinical Research - Whittier

Whittier 5409059, California 5332921, 90602

Vida Clinical Research, Kissimmee 4160983, Florida 4155751

Status

Recruiting

Address

Vida Clinical Research

Kissimmee 4160983, Florida 4155751, 34741

Life Clinical Trials, Margate 4163407, Florida 4155751

Status

Recruiting

Address

Life Clinical Trials

Margate 4163407, Florida 4155751, 33063

CZ Rheumatology, Miami Beach 4164143, Florida 4155751

Status

Recruiting

Address

CZ Rheumatology

Miami Beach 4164143, Florida 4155751, 33140

Vitalia Medical Research, Palm Beach Gardens 4167519, Florida 4155751

Status

Recruiting

Address

Vitalia Medical Research

Palm Beach Gardens 4167519, Florida 4155751, 33410

International Center for Research, Tampa 4174757, Florida 4155751

Status

Recruiting

Address

International Center for Research

Tampa 4174757, Florida 4155751, 33614

Conquest Research, Winter Park 4178560, Florida 4155751

Status

Not yet recruiting

Address

Conquest Research

Winter Park 4178560, Florida 4155751, 32789

Atlanta Research Center for Rheumatology, Marietta 4207783, Georgia 4197000

Status

Recruiting

Address

Atlanta Research Center for Rheumatology

Marietta 4207783, Georgia 4197000, 30060

Satilla Rheumatology & Internal Medicine, Waycross 4229763, Georgia 4197000

Status

Recruiting

Address

Satilla Rheumatology & Internal Medicine

Waycross 4229763, Georgia 4197000, 31501

Great Lakes Clinical Trials - Ravenswood, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

Great Lakes Clinical Trials - Ravenswood

Chicago 4887398, Illinois 4896861, 60640

Greater Chicago Specialty Physicians, Schaumburg 4910713, Illinois 4896861

Status

Recruiting

Address

Greater Chicago Specialty Physicians

Schaumburg 4910713, Illinois 4896861, 60195

Arnold Arthritis & Rheumatology, Skokie 4911600, Illinois 4896861

Status

Recruiting

Address

Arnold Arthritis & Rheumatology

Skokie 4911600, Illinois 4896861, 60076

Willow Rheumatology and Wellness PLLC, Willowbrook 4916709, Illinois 4896861

Status

Recruiting

Address

Willow Rheumatology and Wellness PLLC

Willowbrook 4916709, Illinois 4896861, 60527

Lake Cumberland Rheumatology, New Albany 4262045, Indiana 4921868

Status

Recruiting

Address

Lake Cumberland Rheumatology

New Albany 4262045, Indiana 4921868, 47150

Accurate Clinical Research, Inc, Lake Charles 4330236, Louisiana 4331987

Status

Recruiting

Address

Accurate Clinical Research, Inc

Lake Charles 4330236, Louisiana 4331987, 70605

Klein & Associates, M.D., P.A., Cumberland 4352681, Maryland 4361885

Status

Recruiting

Address

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

Cumberland 4352681, Maryland 4361885, 21502

Klein & Associates, M.D., P.A., Hagerstown 4357141, Maryland 4361885

Status

Recruiting

Address

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

Hagerstown 4357141, Maryland 4361885, 21740

Saint Clair Shores 5010978, Michigan 5001836

Status

Recruiting

Address

Clinical Research Institute of Michigan, LLC

Saint Clair Shores 5010978, Michigan 5001836, 48081

Logan Health Rheumatology, Kalispell 5660340, Montana 5667009

Status

Recruiting

Address

Logan Health Rheumatology

Kalispell 5660340, Montana 5667009, 59901

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

Status

Recruiting

Address

University of Rochester Medical Center

Rochester 5134086, New York 5128638, 14642

Salisbury 4489985, North Carolina 4482348

Status

Recruiting

Address

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury 4489985, North Carolina 4482348, 28144

Middleburg Heights 5162851, Ohio 5165418

Status

Recruiting

Address

Paramount Medical Research & Consulting, LLC

Middleburg Heights 5162851, Ohio 5165418, 44130

Essential Medical Research, Tulsa 4553433, Oklahoma 4544379

Status

Recruiting

Address

Essential Medical Research

Tulsa 4553433, Oklahoma 4544379, 74137

West Tennessee Research Institute, Jackson 4632595, Tennessee 4662168

Status

Recruiting

Address

West Tennessee Research Institute

Jackson 4632595, Tennessee 4662168, 38305

Murfreesboro 4644312, Tennessee 4662168

Status

Recruiting

Address

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro 4644312, Tennessee 4662168, 37128

Colleyville 4682478, Texas 4736286

Status

Recruiting

Address

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville 4682478, Texas 4736286, 76034

Fort Worth 4691930, Texas 4736286

Status

Recruiting

Address

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

Fort Worth 4691930, Texas 4736286, 76109

Accurate Clinical Research, Inc, Houston 4699066, Texas 4736286

Status

Recruiting

Address

Accurate Clinical Research, Inc

Houston 4699066, Texas 4736286, 77089

Research Physicians Network, LLC, Houston 4699066, Texas 4736286

Status

Recruiting

Address

Research Physicians Network, LLC

Houston 4699066, Texas 4736286, 77089

Irving 4700168, Texas 4736286

Status

Recruiting

Address

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

Irving 4700168, Texas 4736286, 75039

Biopharma Informatic, LLC, Katy 4702732, Texas 4736286

Status

Recruiting

Address

Biopharma Informatic, LLC

Katy 4702732, Texas 4736286, 77494

SouthWest Rheumatology Research, LLC, Mesquite 4710826, Texas 4736286

Status

Not yet recruiting

Address

SouthWest Rheumatology Research, LLC

Mesquite 4710826, Texas 4736286, 75150

The Woodlands 4736476, Texas 4736286

Status

Recruiting

Address

Advanced Rheumatology of Houston - Woodlands

The Woodlands 4736476, Texas 4736286, 77382

DM Clinical Research - TRA, Tomball 4737094, Texas 4736286

Status

Recruiting

Address

DM Clinical Research - TRA

Tomball 4737094, Texas 4736286, 77375

Seattle Rheumatology Associates PLLC, Seattle 5809844, Washington 5815135

Status

Recruiting

Address

Seattle Rheumatology Associates PLLC

Seattle 5809844, Washington 5815135, 98104

Arthritis Northwest, PLLC, Spokane 5811696, Washington 5815135

Status

Recruiting

Address

Arthritis Northwest, PLLC

Spokane 5811696, Washington 5815135, 99204

International Sites

Reuviva Research Center, Guaynabo 4565119, Puerto Rico

Status

Recruiting

Address

Reuviva Research Center

Guaynabo 4565119, , 00968

Caribbean Medical Research Center, San Juan 4568127, Puerto Rico

Status

Recruiting

Address

Caribbean Medical Research Center

San Juan 4568127, , 00918