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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last up to 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well adding tirzepatide to ixekizumab works for people with moderate-to-severe plaque psoriasis, a skin disease that causes thick, scaly patches. It is for people who also have obesity, or are overweight with at least one weight-related health problem. The study lasts up to 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have moderate-to-severe plaque psoriasis diagnosed by a skin doctor or another health care provider experienced in treating it.
  • Have a BMI of 30 or higher, or a BMI from 27 to below 30 with a weight-related health problem. BMI is a measure based on height and weight.
  • If your BMI is from 27 to below 30, have high blood pressure, unhealthy blood fat levels, type 2 diabetes, sleep apnea (breathing stops and starts during sleep), or heart or blood vessel disease.
  • Have started ixekizumab 2 to 4 months before the decision to add tirzepatide.
  • Be able to start tirzepatide within 30 days of that decision.

Who can't join

  • Have used ixekizumab for less than 2 months or more than 4 months.
  • Have ever used tirzepatide or another GLP-1 medicine, such as dulaglutide, liraglutide, or semaglutide.
  • Are currently in another clinical study.
  • Have a known allergy to tirzepatide or any of its ingredients.
  • You or a family member have had medullary thyroid cancer, or you have multiple endocrine neoplasia type 2, a condition that causes tumors in hormone-making glands.
  • Have type 1 diabetes; a history of dangerous acid buildup or extreme blood sugar levels called a hyperosmolar state or coma; or severe low blood sugar and trouble noticing low blood sugar in the past 6 months.
  • Have ever had pancreatitis (swelling of the pancreas), or severe stomach or bowel problems, including slow stomach emptying, acid reflux, indigestion, or ongoing nausea, constipation, or vomiting.
  • Have a history of diabetes-related eye disease involving abnormal blood vessel growth, damage to the central part of the retina, or other retinal damage needing urgent treatment. The retina is the light-sensing layer at the back of the eye.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (39)

AZ

CA

FL

GA

IN

KY

MA

MD

  • Dermatology and Skin Cancer Specialists, LLC · Rockville, MD 20850Benjamin Lockshin · Principal investigatorMore trials in Rockville

MI

NC

NH

NJ

NV

NY

OH

OR

PA

SC

TN

TX

UT

WA