Tests mirikizumab with or without tirzepatide in adults with Crohn's disease and excess weight
Tests mirikizumab alone or with tirzepatide in adults with Crohn's and excess weight.
Plain-language title generated from the registry record
Registry title: Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Key facts
- Where
- Bologna, Castellana Grotte, Milan, Padova, Pisa, Rho, Roma, and Rozzano, ItalySee the 9 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06937099, who can take part
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaBologna, ItalyTaking people
- Ospedale Specializzato in Gastroenterologia "Saverio de Bellis"Castellana Grotte, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Ospedale San RaffaeleMilan, ItalyTaking people
- Azienda Ospedale Universita PadovaPadova, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Ospedale Di CircoloRho, ItalyTaking people
- Fondazione Policlinico Universitario Agostino GemelliRoma, ItalyTaking people
- HumanitasRozzano, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06937099EU 2024-520210-21-00
- Record updated
- 4 November 2026
- Original description
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.Read full original descriptionShow less
A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.
The maximum duration of this study is up to 61 weeks.
Inclusion: Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD; Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to <30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:; hypertension; Type 2 diabetes mellitus (T2DM); dyslipidemia; obstructive sleep apnea, or; cardiovascular disease; Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline; Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment; Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline; Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy.
Exclusion: Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening; Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis; Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline; Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM; Have a current or recent acute, active infection; Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum; Currently have or are suspected to have an abscess; Have a stoma, ileoanal pouch, or ostomy; Have had more than 5% body weight change in the past 3 months.