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
- Aracaju, Brasília, Campinas, Caxias do Sul, Curitiba, Juiz de Fora, Porto Alegre, Ribeirão Preto, Salvador, Santo André, São Paulo, Vitória, and Votuporanga, BrazilSee the 15 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active Crohn's disease who also have obesity or overweight.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Moderately to severely active Crohn's disease, with a CDAI score of at least 220. A centrally read SES-CD score of at least 6 (ileal-colonic disease) or at least 4 (isolated ileal disease) is also needed.
- Earlier treatment
- Must have had an inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced Crohn's disease therapy.
- Biomarker or test result
- BMI of at least 30 kg/m², or BMI of at least 27 to under 30 kg/m² with at least 1 weight-related condition (hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea or cardiovascular disease).
Main reasons for not taking part
- Ulcerative colitis, unclassified inflammatory bowel disease or primary sclerosing cholangitis
- A stoma, ileoanal pouch or ostomy
- Type 1 diabetes or insulin-treated type 2 diabetes
- More than 5% body weight change in the past 3 months
- Current or recent acute, active infection
Read by machine on 9 November 2026.
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 Brazil
- NewData Clinical Research - AracajuAracaju, BrazilTaking people
- L2IP - Instituto de Pesquisas ClínicasBrasília, BrazilTaking people
- Loema Instituto de Pesquisa ClinicaCampinas, BrazilTaking people
- Fundação Universidade de Caxias do Sul (FUCS)Caxias do Sul, BrazilTaking people
- Centro Digestivo de CuritibaCuritiba, BrazilTaking people
- Galileo Medical ResearchJuiz de Fora, BrazilTaking people
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilTaking people
- Hospital de Clínicas de Ribeirão PretoRibeirão Preto, BrazilTaking people
- CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e NutriçãoSalvador, BrazilTaking people
- Pesquisare SaudeSanto André, BrazilTaking people
- CEPIC - Centro Paulista de Investigação ClínicaSão Paulo, BrazilTaking people
- Clínica Hepatogastro JKSão Paulo, BrazilTaking people
- CPQuali Pesquisa ClínicaSão Paulo, BrazilTaking people
- CEDOESVitória, BrazilTaking people
- Integral Pesquisa e EnsinoVotuporanga, BrazilTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.