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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

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) (NCT06857942) is a Phase 4 interventional studying Psoriasis and Overweight or Obesity, sponsored by Eli Lilly and Company. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Psoriasis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Tirzepatide

Administered SC

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Medical Dermatology Specialists
Phoenix, Arizona, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
Metropolis Dermatology
Los Angeles, California, United States
Northridge Clinical Trials
Northridge, California, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States
NeoClinical Research
Hialeah, Florida, United States
Skin Care Research
Hollywood, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
TruDerm & TruSpa
Wellington, Florida, United States
Southeast Research Specialists
Douglasville, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
David Fivenson, MD, PLC
Ann Arbor, Michigan, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
The Derm Institute of West Michigan
Caledonia, Michigan, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06857942), the sponsor (Eli Lilly and Company), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06857942 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06857942?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06857942?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06857942. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06857942. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.