DRUG
Ixekizumab
Administered SC
Status
Completed
Phase
Phase 3
Enrollment
281
Locations
72
Results
Not posted
Publications
1
Study summary
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
DRUG
Administered SC
DRUG
Administered SC.
Timeline
First posted
Sep 19, 2024
Study start
Sep 30, 2024
Primary completion
Jan 8, 2026
Study completion
Jun 1, 2026
Results posted
Not reported
Registry updated
Jun 17, 2026
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.
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
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
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
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