Last updated 29 days ago
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
350 patients around the world
Available in Brazil, Mexico
Eli Lilly and Company
7Research sites
350Patients around the world
This study is for people with
Obesity
Ulcerative colitis
Moderate/severe ulcerative colitis
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.Have obesity, body mass index (BMI) 30 kilograms per meter squared (kg/m2).Have overweight (BMI ≥27 kg/m2 to <30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions.Hypertension.Type 2 Diabetes Mellitus (T2DM).Dyslipidemia.Obstructive sleep apnea.Cardiovascular disease.Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1 inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.
- Have a current diagnosis of Crohn's disease.Have a current diagnosis of inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis).Have a current diagnosis of primary sclerosing cholangitis.Have had or will need bowel resection or intestinal or intra-abdominal surgery.Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.Have a current or recent acute, active infection.
Sites
Fundação Universidade de Caxias do Sul
Clínica Hepatogastro JK
Cedoes - Pesquisa e Diagnóstico
CPQuali Pesquisa Clínica
Clínica Loema
Boca Clinical Trials Mexico SC - CDMX
Centro de Investigación Clínica Chapultepec - Sanatorio La Luz
StudyCOMMIT-UC
SponsorEli Lilly and Company
Study typeInterventional
Conditions
ObesityModerate/severe ulcerative colitis
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06937086
