Combining ixekizumab and tirzepatide for treating psoriasis and obesity
Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsO)
This study is testing if using ixekizumab with tirzepatide can help adults with moderate to severe psoriasis who are also overweight or obese feel better and lose weight more effectively than just using ixekizumab alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | ixekizumab |
| Locations | 72 sites (Birmingham, Alabama and 71 other locations) |
| Trial ID | NCT06588283 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of administering ixekizumab alongside tirzepatide in adults suffering from moderate to severe plaque psoriasis and obesity or overweight. Participants will undergo up to 12 visits over a period of 61 weeks, which includes screening, treatment, and follow-up phases. The primary goal is to assess improvements in psoriasis symptoms and weight reduction compared to treatment with ixekizumab alone. The study focuses on individuals with specific weight-related comorbid conditions to determine the combined treatment's efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate-to-severe plaque psoriasis and obesity or overweight, specifically those with at least one weight-related comorbidity.
Not a fit: Patients with Type 1 Diabetes Mellitus, insulin-treated Type 2 Diabetes Mellitus, or those with certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved psoriasis management and weight loss for patients with these concurrent conditions.
How similar studies have performed: While the combination of these specific treatments is novel, previous studies have shown success with similar approaches in managing psoriasis and obesity.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 71 other locations
- Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology — Birmingham, Alabama, United States (Active_not_recruiting)
- Medical Dermatology Specialists — Phoenix, Arizona, United States (Active_not_recruiting)
- Scottsdale Clinical Trials — Scottsdale, Arizona, United States (Active_not_recruiting)
- Yuma Clinical Trials — Yuma, Arizona, United States (Recruiting)
- Johnson Dermatology — Fort Smith, Arkansas, United States (Active_not_recruiting)
- California Dermatology & Clinical Research Institute — Encinitas, California, United States (Active_not_recruiting)
- First OC Dermatology Research Inc — Fountain Valley, California, United States (Active_not_recruiting)
- Avance Clinical Trials — Laguna Niguel, California, United States (Active_not_recruiting)
- Metropolis Dermatology — Los Angeles, California, United States (Active_not_recruiting)
- Dermatology Research Associates — Los Angeles, California, United States (Active_not_recruiting)
- Northridge Clinical Trials — Northridge, California, United States (Active_not_recruiting)
- Cura Clinical Research - Oxnard — Oxnard, California, United States (Active_not_recruiting)
- Integrative Skin Science and Research - Location 2 — Sacramento, California, United States (Active_not_recruiting)
- Therapeutics Clinical Research — San Diego, California, United States (Active_not_recruiting)
- Life Clinical Trials — Coral Springs, Florida, United States (Active_not_recruiting)
- Alliance for Multispecialty Research, LLC — Fort Myers, Florida, United States (Active_not_recruiting)
- NeoClinical Research — Hialeah, Florida, United States (Active_not_recruiting)
- Skin Care Research — Hollywood, Florida, United States (Active_not_recruiting)
- Encore Medical Research — Hollywood, Florida, United States (Active_not_recruiting)
- Solutions Through Advanced Research — Jacksonville, Florida, United States (Active_not_recruiting)
- Deluxe Health Center — Miami Lakes, Florida, United States (Active_not_recruiting)
- Renstar Medical Research — Ocala, Florida, United States (Active_not_recruiting)
- Leading Edge Dermatology — Plantation, Florida, United States (Active_not_recruiting)
- International Clinical Research - Sanford — Sanford, Florida, United States (Active_not_recruiting)
- Nodal Medical Center — Tampa, Florida, United States (Active_not_recruiting)
- Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research — Tampa, Florida, United States (Active_not_recruiting)
- DeNova Research — Chicago, Illinois, United States (Active_not_recruiting)
- Oak Dermatology — Naperville, Illinois, United States (Active_not_recruiting)
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States (Active_not_recruiting)
- The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States (Active_not_recruiting)
- Equity Medical - Bowling Green — Bowling Green, Kentucky, United States (Active_not_recruiting)
- DelRicht Research — Baton Rouge, Louisiana, United States (Active_not_recruiting)
- Care Access - Lake Charles (Bayou Pines) — Lake Charles, Louisiana, United States (Active_not_recruiting)
- Dermatology and Skin Cancer Specialists, LLC — Rockville, Maryland, United States (Completed)
- Lawrence J. Green, MD, LLC — Rockville, Maryland, United States (Active_not_recruiting)
- Great Lakes Research Group, Inc. — Bay City, Michigan, United States (Active_not_recruiting)
- The Derm Institute of West Michigan — Caledonia, Michigan, United States (Active_not_recruiting)
- MI Skin Innovations — Northville, Michigan, United States (Active_not_recruiting)
- Las Vegas Dermatology — Las Vegas, Nevada, United States (Active_not_recruiting)
- Skin Cancer and Dermatology Institute - Reno — Reno, Nevada, United States (Active_not_recruiting)
- ActivMed Practices & Research, LLC. — Portsmouth, New Hampshire, United States (Active_not_recruiting)
- Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States (Active_not_recruiting)
- Care Access - Hoboken — Hoboken, New Jersey, United States (Active_not_recruiting)
- Equity Medical — New York, New York, United States (Active_not_recruiting)
- Mount Sinai Doctors - East 85th Street — New York, New York, United States (Active_not_recruiting)
- Onsite Clinical Solutions - Huntersville — Huntersville, North Carolina, United States (Active_not_recruiting)
- Red River Research Partners — Fargo, North Dakota, United States (Active_not_recruiting)
- Optima Research - Boardman — Boardman, Ohio, United States (Active_not_recruiting)
- Dermatologists of Southwest Ohio — Mason, Ohio, United States (Active_not_recruiting)
- Oregon Medical Research Center — Portland, Oregon, United States (Active_not_recruiting)
+22 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 3176154559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.