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NCT Number: 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)

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.

Recruiting

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Key information

Conditions

Psoriasis Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Dermatology Specialists, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

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

    Time frame: 12 months

    The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.

  2. Percentage of Participants Achieving at least 10% Weight Reduction

    Time frame: 12 months

    Percentage of participants achieving at least 10% weight reduction.

Secondary outcomes

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

    Time frame: Month 6 and Month 12

    The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area.

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

    Time frame: Month 6 and Month 12

    The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area.

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

    Time frame: Month 6 and Month 12

    The sPGA is an investigator-administered multi-item scale. It determines the participant's psoriasis (PsO) lesions, overall, at a given time point. Overall lesions are graded for plaque elevation, scaling, and erythema, on a range of clear (0), almost clear (1), mild (2), moderate (3), and severe (4).

  4. Percentage of Participants Achieving DLQI ≤5

    Time frame: Month 6 and Month 12

    The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.

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

    Time frame: Month 6 and Month 12

    The PatGA of Psoriasis is a patient-reported single-item scale. Patient Global Assessments allow for an overall evaluation of disease severity or global impact of the disease from the patient's perspective. Participants are asked to rank the severity of their PsO "today" by selecting a number on a 0-to-5 numeric rating scale, with 0 indicating clear/no PsO and 5 indicating severe PsO.

  6. Mean Percent Change of Weight from Baseline

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

    Mean percent change of weight from baseline.

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

    Time frame: Month 6 and Month 12

    The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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