← Trials/Trial dossier/NCT06857942

RecruitingPhase 4

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)

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

41

Recruiting sites

41

Enrollment

200

estimated

Study population

Obesity / overweight, Psoriasis / psoriatic arthritis

Key I/E criterion

Primary endpoints

Dermatology Life Quality Index (DLQI) (0,1)≥10% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06857942
Org study ID27319
Secondary IDI1F-MC-RHDDEli Lilly and Company

Timeline

Milestones

Study first posted2025-03-05actual
Study start2025-03-19actual
Last update posted2026-05-14actual
Primary completion2028-05estimated (month precision)
Study completion2028-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPsoriasis / psoriatic arthritis

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL
4
Other clinical outcomes
3
Weight & body composition
2

Weight & body composition

2 endpoints
Primary/protocol endpoint

Percentage of Participants Achieving at least 10% Weight Reduction

Time frame:12 months

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Mean Percent Change of Weight from Baseline

Time frame:Baseline, Month 6 and Baseline, Month 12

Body weight, % change

percent change from baseline, improvement

Patient-reported / QoL

4 endpoints
Primary/protocol endpoint

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1)

Time frame:12 months

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving DLQI ≤5

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2

Time frame:Month 6 and Month 12

PGI, change

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Achieving DLQI Score (0,1) and Least 10% Weight Reduction

Time frame:Month 6 and Month 12

threshold achievement, improvement

componentsdlqi threshold 0 1, ≥10% weight-loss responders

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint

Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target]

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal)

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1)

Time frame:Month 6 and Month 12

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.