Current partner codePEPTIDESDE
NCT06588283·Phase 3·INTERVENTIONAL

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Status

Completed

Phase

Phase 3

Enrollment

281

Locations

72

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab. Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.

Interventions

Treatment arms and agents.

DRUG

Ixekizumab

Administered SC

DRUG

Tirzepatide

Administered SC.

Timeline

From registration to results.

  1. First posted

    Sep 19, 2024

  2. Study start

    Sep 30, 2024

  3. Primary completion

    Jan 8, 2026

  4. Study completion

    Jun 1, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jun 17, 2026

Outcomes

What the study measures.

Primary outcomes

Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction

Time frame · Baseline to Week 36

PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI score compared to baseline.

Secondary outcomes

Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction

Time frame · Baseline to Week 36

PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately, and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

Percentage of Participants Achieving PASI 100

Time frame · Baseline to Week 36

PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately, and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

Percentage of Participants Achieving At Least 10% Weight Reduction

Time frame · Baseline to Week 36

Percentage of Participants Who Achieved at Least a 10% Weight Reduction

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months. * Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12. * Have ≥10% body surface area (BSA) involvement. * Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to \<30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM). Exclusion Criteria: Medical Conditions * Have Type 1 Diabetes Mellitus (T1DM). * Have insulin-treated Type 2 Diabetes Mellitus (T2DM). * Have a prior or planned surgical treatment for obesity. * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2. * Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis). * Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions: * basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years. * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization. * Have serious disorder or illness other than PsO. * Have a history of chronic or acute pancreatitis. * Have any prior use of ixekizumab or tirzepatide. * Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.

Study locations

72 registered sites.

Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.

Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

Birmingham, Alabama, United States

Medical Dermatology Specialists

Phoenix, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Yuma Clinical Trials

Yuma, Arizona, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

First OC Dermatology Research Inc

Fountain Valley, California, United States

Avance Clinical Trials

Laguna Niguel, California, United States

Metropolis Dermatology

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Northridge Clinical Trials

Northridge, California, United States

Cura Clinical Research - Oxnard

Oxnard, California, United States

Integrative Skin Science and Research - Location 2

Sacramento, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Life Clinical Trials

Coral Springs, Florida, 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

Solutions Through Advanced Research

Jacksonville, Florida, United States

Deluxe Health Center

Miami Lakes, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Leading Edge Dermatology

Plantation, Florida, United States

International Clinical Research - Sanford

Sanford, Florida, United States

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.