Clinical trial NCT06857942: A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
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 Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight in Clinical Practice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Overweight or Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.

The study will last up to 12 months.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant)
* Have 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 mellitus, obstructive sleep apnea, or cardiovascular diseases).
* Must have initiated treatment 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/screening).

Exclusion Criteria:

* Have currently received ixekizumab for more than 4 months or less than 2 months.
* Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide.
* Are currently enrolled in any other clinical study.

Other exclusions

* Have a known hypersensitivity to tirzepatide or to any of its component.
* Have a personal or family history of medullary thyroid cancer.
* Have multiple endocrine neoplasia type 2.
* Have type I diabetes mellitus.
* Have a history of chronic or acute pancreatitis at any time before screening (Visit 1).
* 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 and hypoglycemia unawareness within the 6 months before screening.
* Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.

Primary outcomes:
measure: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1)
timeFrame: 12 months
measure: Percentage of Participants Achieving at least 10% Weight Reduction
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target]
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal)
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1)
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving DLQI ≤5
timeFrame: Month 6 and Month 12
measure: Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2
timeFrame: Month 6 and Month 12
measure: Mean Percent Change of Weight from Baseline
timeFrame: Baseline, Month 6 and Baseline, Month 12
measure: Percentage of Participants Achieving DLQI Score (0,1) and Least 10% Weight Reduction
timeFrame: Month 6 and Month 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Rocklin
country: United States
facility: NorCal Clinical Research
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research - Location 3
state: California
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Hialeah
country: United States
facility: NeoClinical Research
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Tampa
country: United States
facility: Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
state: Florida
city: Douglasville
country: United States
facility: Southeast Research Specialists
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Bowling Green
country: United States
facility: Equity Medical - Bowling Green
state: Kentucky
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC
state: Maryland
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan
state: Michigan
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute - Reno
state: Nevada
city: Portsmouth
country: United States
facility: Stracskin
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Hoboken
country: United States
facility: Care Access - Hoboken
state: New Jersey
city: New York
country: United States
facility: Equity Medical
state: New York
city: Huntersville
country: United States
facility: Onsite Clinical Solutions - Huntersville
state: North Carolina
city: Boardman
country: United States
facility: Optima Research - Boardman
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Dermatology & Aesthetics
state: South Carolina
city: Myrtle Beach
country: United States
facility: Alliance for Multispecialty Research, LLC
state: South Carolina
city: Smyrna
country: United States
facility: DelRicht Research - Thompson's Station
state: Tennessee
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Bellevue
country: United States
facility: Bellevue Dermatology Clinic
state: Washington
city: Burien
country: United States
facility: Dermatology of Seattle
state: Washington
city: Carolina
country: Puerto Rico
facility: Office of Dr. Alma M. Cruz
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: