GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 4

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)

A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice.

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

200

estimated

Study population

Obesity / overweight, Psoriasis / psoriatic arthritis

Key I/E criterion

—

Primary endpoints

•Normalized Functioning Health Assessment Questionnaire - Disability Index•≥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 IDNCT06864026

Org study ID27350

Secondary IDI1F-MC-RHDEEli Lilly and Company

Timeline

Milestones

Study start2025-03-06actual

Study first posted2025-03-07actual

Last update posted2026-02-10actual

Primary completion2027-11estimated (month precision)

Study completion2027-11estimated (month precision)

Assets

Investigational agents

Tirzepatide

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 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.

Endpoints (15)

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

Weight & body composition

Other clinical outcomes

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

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

Time frame:12 Months

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants with ≥10% Weight Loss at Month 6

Time frame:Month 6

≥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

8 endpoints

Primary/protocol endpoint

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

Time frame:12 Months

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Month 6 and Month 12

PGI, change

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)

Time frame:Month 6 and Month 12

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID

Time frame:Month 6 and Month 12

SF-36 mental

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving a HAQ-DI score ≤0.5

Time frame:Month 6

threshold achievement, improvement

Other clinical outcomes

3 endpoints

Secondary/protocol endpoint

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

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Month 6 and Month 12

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Month 6 and Month 12

threshold achievement, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss

Time frame:Month 6 and Month 12

threshold achievement, improvement

componentshaq di threshold 0.5, ≥10% weight-loss responders

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.