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Search / Trial NCT06937099

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Launched by ELI LILLY AND COMPANY · Apr 18, 2025

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a treatment combining two medications, mirikizumab and tirzepatide, for adults who have Crohn's disease that is moderately to severely active, along with obesity or being overweight. The study aims to see how this combination compares to mirikizumab alone. Participants will be involved for up to 61 weeks, during which they will receive either the combination treatment or a placebo (a non-active treatment).

To be eligible for this trial, participants must have been diagnosed with Crohn's disease for at least three months and have a body mass index (BMI) indicating obesity or being overweight, along with certain related health conditions like high blood pressure or diabetes. They should also have had insufficient response to previous treatments for Crohn's disease. Those with other specific health issues, such as certain types of infections or surgeries, may not be able to participate. If eligible, participants can expect regular check-ups and monitoring throughout the study to assess their condition and the treatment's effects.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Have had a diagnosis of Crohn's disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria.
  • * 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 of these 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.
  • Have a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
  • * Have an inadequate response to, loss of response to, or intolerance to:
  • at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
  • at least one advanced therapy for CD (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrin antibodies, Janus kinase (JAK) inhibitors such as upadacitinib, or anti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).
  • Exclusion Criteria:
  • Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
  • 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 a history of more than 3 small bowel resections, 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 history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
  • Have had more than 5% body weight change in the past 3 months
  • Have a current or recent acute, active infection.

About Eli Lilly And Company

Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.

Locations

Saint Louis, Missouri, United States

Copenhagen, , Denmark

Lebanon, New Hampshire, United States

Chicago, Illinois, United States

Madrid, , Spain

Vancouver, British Columbia, Canada

Hannover, , Germany

Milwaukee, Wisconsin, United States

Gijón, Asturias, Spain

Brussels, , Belgium

Milano, , Italy

Sevilla, , Spain

Porto Alegre, Rio Grande Do Sul, Brazil

Barcelona, , Spain

Usti Nad Labem, , Czechia

Bucuresti, , Romania

Barcelona, , Spain

Paris, , France

Orlando, Florida, United States

Utrecht, , Netherlands

Graz, Steiermark, Austria

Potsdam, Brandenburg, Germany

Budapest, , Hungary

Beverly Hills, California, United States

Leuven, Vlaams Brabant, Belgium

Eskisehir, , Turkey

Galdakao, Bizkaia, Spain

San Antonio, Texas, United States

Madrid, , Spain

Heraklion, , Greece

Indianapolis, Indiana, United States

Oviedo, Asturias, Spain

Szeged, Csongrád, Hungary

Tel Aviv, , Israel

Durango, , Mexico

Rotterdam, Zuid Holland, Netherlands

Nijmegen, Gelderland, Netherlands

Idaho Falls, Idaho, United States

Thessaloniki, , Greece

Leipzig, Sachsen, Germany

Timisoara, , Romania

Ioannina, , Greece

Athens, , Greece

Shreveport, Louisiana, United States

Roma, Lazio, Italy

české Budějovice, , Czechia

Szeged, , Hungary

Jerusalem, Yerushalayim, Israel

Veracruz, , Mexico

Milano, Lombardia, Italy

Santo André, , Brazil

València, , Spain

Piotrkow Trybunalski, , Poland

Guadalajara, Jalisco, Mexico

Pisa, Toscana, Italy

La Roche Sur Yon, , France

Izmit, Kocaeli, Turkey

Northridge, California, United States

Mersin, , Turkey

Halle (Saale), Sachsen Anhalt, Germany

Kortrijk, West Vlaanderen, Belgium

Sunrise, Florida, United States

Tyler, Texas, United States

São Paulo, , Brazil

Aarhus, Midtjylland, Denmark

Le Kremlin Bicêtre, Paris, France

Rotterdam, Zuid Holland, Netherlands

Ramat Gan, Hamerkaz, Israel

Dothan, Alabama, United States

Orlando, Florida, United States

Edmonton, Alberta, Canada

București, , Romania

Bursa, , Turkey

Rho, Milano, Italy

Lubbock, Texas, United States

Toulouse, Haute Garonne, France

Marseille, Bouches Du Rhône, France

Chevy Chase, Maryland, United States

Usti Nad Labem, ústí Nad Labem, Czechia

São Paulo, , Brazil

Merida, Yucatán, Mexico

Morelia, , Mexico

San Antonio, Texas, United States

Vienna, Wien, Austria

Brussels, Bruxelles Capitale, Région De, Belgium

Liège, , Belgium

Aalborg, Nordjylland, Denmark

Vejle, Syddanmark, Denmark

Frankfurt, Hessen, Germany

Vitória, Espírito Santo, Brazil

Szczecin, Zachodniopomorskie, Poland

Rouen, Haute Normandie, France

Santo André, São Paulo, Brazil

Haifa, Hatsafon, Israel

Rozzano, Lombardia, Italy

Barcelona, Barcelona [Barcelona], Spain

Athens, Attikí, Greece

Pamplona, Navarra, Spain

Copenhagen, Hovedstaden, Denmark

La Roche Sur Yon, Vendée, France

Petah Tikva, Hamerkaz, Israel

Tel Aviv, Tell Abīb, Israel

Constanta, Constanța, Romania

Votuporanga, São Paulo, Brazil

Holon, Hamerkaz, Israel

Liege, Liège, Belgium

Ioannina, Ioánnina, Greece

Antalya, , Turkey

Ribeirão Preto, São Paulo, Brazil

Innsbruck, Tirol, Austria

Nice, Alpes Maritimes, France

Craiova, Dolj, Romania

New York, New York, United States

Heraklion, Krítí, Greece

London, Ontario, Canada

Toulouse Cedex 9, Haute Garonne, France

Anaheim, California, United States

Neuilly Sur Seine, Hauts De Seine, France

Piotrkow Trybunalski, łódzkie, Poland

Rzeszów, Podkarpackie, Poland

Votuporanga, , Brazil

San Juan, , Puerto Rico

Szekszárd, Tolna, Hungary

Prague, Praha 9, Czechia

Marseille, , France

Ciudad Madero, Tamaulipas, Mexico

Barcelona, Barcelona [Barcelona], Spain

Campinas, São Paulo, Brazil

Bologna, Emilia Romagna, Italy

Chihuahua, , Mexico

New Albany, Indiana, United States

Padova, Veneto, Italy

Tacoma, Washington, United States

Montpellier, Languedoc Roussillon, France

Banska Bystrica, Banskobystrický Kraj, Slovakia

Cordova, Tennessee, United States

São Paulo, , Brazil

Timisoara, Timiș, Romania

Salvador, Bahia, Brazil

Juriquilla, Querétaro, Mexico

New Bedford, Massachusetts, United States

Frankfurt Am Main, Hessen, Germany

İzmir, , Turkey

Zagreb, Grad Zagreb, Croatia

Lublin, Lubelskie, Poland

Ashdod, Hadarom, Israel

Istanbul, , Turkey

Constanta, , Romania

Thessaloniki, Kentrikí Makedonía, Greece

Puebla, , Mexico

Bucuresti, București, Romania

Guadalajara, Jalisco, Mexico

Guadajalara, Jalisco, Mexico

Athens, Attikí, Greece

Amsterdam, Noord Holland, Netherlands

Caxias Do Sul, Rio Grande Do Sul, Brazil

Brasília, Distrito Federal, Brazil

Westlake, Ohio, United States

Belgrade, Beograd, Serbia

Bialystok, Podlaskie, Poland

Liege, , Belgium

Warszawa, Mazowieckie, Poland

Louisville, Kentucky, United States

Palermo, Sicilia, Italy

Aguascalientes, , Mexico

Morelia, Michoacán, Mexico

Aalst, Oost Vlaanderen, Belgium

Miami, Florida, United States

Wroclaw, Dolnośląskie, Poland

Bratislava, , Slovakia

Providence, Rhode Island, United States

Aracaju, Sergipe, Brazil

Vancouver, British Columbia, Canada

Brno, Brno Město, Czechia

české Budějovice, Jihočeský Kraj, Czechia

Turnov, Liberecký Kraj, Czechia

Ostrava, Moravskoslezský Kraj, Czechia

Prague, Praha 4, Czechia

Hradec Králové, , Czechia

échirolles, Isère, France

Montfermeil, Paris, France

Saint Priest En Jarez, Rhône Alpes, France

Grevenbroich, Nordrhein Westfalen, Germany

Zerifin, Hamerkaz, Israel

Castellana Grotte, Puglia, Italy

Monterrey, Nuevo León, Mexico

Mexico City, , Mexico

Zamość, Lubelskie, Poland

Warsaw, Mazowieckie, Poland

Warszawa, Mazowieckie, Poland

Poznan, Wielkopolskie, Poland

Poznań, Wielkopolskie, Poland

Bacau, Bacău, Romania

Kosice, Košický Kraj, Slovakia

Presov, , Slovakia

Hatay, , Turkey

Wroclaw, , Poland

New Iberia, Louisiana, United States

Miami, Florida, United States

Yonkers, New York, United States

Juiz De Fora, Minas Gerais, Brazil

Curitiba, Paraná, Brazil

London, Ontario, Canada

Nantes, Pays De La Loire, France

Banska Bystrica, , Slovakia

Ribeirão Preto, , Brazil

Prague, , Czechia

Vitória, , Brazil

Campinas, , Brazil

Merida, , Mexico

Juriquilla, , Mexico

Athens, , Greece

Curitiba, , Brazil

Brno, , Czechia

Turnov, , Czechia

Ostrava, , Czechia

Prague, , Czechia

échirolles, , France

Saint Priest En Jarez, , France

Monterrey, , Mexico

Bacau, , Romania

Kosice, , Slovakia

Los Alamitos, California, United States

Pensacola, Florida, United States

Fayetteville, North Carolina, United States

Philadelphia, Pennsylvania, United States

Greenville, South Carolina, United States

Gorna Oryahovitsa, Veliko Tarnovo, Bulgaria

Montreal, Quebec, Canada

Tlalnepantla De Baz, , Mexico

Sofia, , Bulgaria

Muratpasa, Antalya, Turkey

Patients applied

0 patients applied

Trial Officials

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

Study Director

Eli Lilly and Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported