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Search / Trial NCT06914895

A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

Launched by ELI LILLY AND COMPANY · Apr 4, 2025

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tirzepatide to see how well it works and how safe it is for adults who have type 1 diabetes and are overweight or obese. If you are interested in participating, you should be between 18 and 75 years old, have been using insulin for at least a year, and have an HbA1c level (a measure of blood sugar control) between 7.0% and 10.5%. You also need to have a body mass index (BMI) of 25 or higher and have maintained a stable weight for the last three months.

The study will last about 49 weeks. During this time, participants will receive either tirzepatide or a placebo (a treatment that looks like the medication but has no active ingredients) to compare the effects. It’s important to note that individuals who have had serious issues with blood sugar control, such as frequent hospital visits for high or low blood sugar, or those currently being treated for eye problems related to diabetes, may not be eligible to join. This trial is not yet recruiting participants, but if you meet the criteria and are interested, it could be a chance to help researchers learn more about managing type 1 diabetes and weight.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Have type 1 diabetes and on insulin treatment for at least one year prior to screening
  • Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
  • Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
  • Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study
  • Exclusion Criteria:
  • Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
  • Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  • Have had chronic or acute pancreatitis
  • Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

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

Springfield, Illinois, United States

Syracuse, New York, United States

Buenos Aires, , Argentina

Honolulu, Hawaii, United States

Barcelona, , Spain

Santander, Cantabria, Spain

Móstoles, Madrid, Spain

Osaka, , Japan

Milano, , Italy

Sevilla, , Spain

Woodstock, Georgia, United States

Leipzig, Sachsen, Germany

Barcelona, , Spain

Marseille, , France

Renton, Washington, United States

Barcelona, , Spain

Corbeil Essonnes, , France

Aurora, Colorado, United States

Atlanta, Georgia, United States

Rockville, Maryland, United States

Barcelona, Catalunya, Spain

Haifa, , Israel

Kofu, Yamanashi, Japan

Indianapolis, Indiana, United States

Tel Aviv, , Israel

Marseille, , France

Jerusalem, Yerushalayim, Israel

Kasugai, Aichi, Japan

Morehead City, North Carolina, United States

Manati, , Puerto Rico

Idaho Falls, Idaho, United States

Firenze, Toscana, Italy

Kure, Hiroshima, Japan

Oldenburg, Schleswig Holstein, Germany

Fukuoka, , Japan

Montpellier, Hérault, France

São Paulo, , Brazil

Essen, Nordrhein Westfalen, Germany

Guadalajara, Jalisco, Mexico

Kumamoto, , Japan

Oita, , Japan

Ramat Gan, Hamerkaz, Israel

Corbeil Essonnes, île De France, France

Haifa, ḥeifā, Israel

Guadalajara, Jalisco, Mexico

Bologna, , Italy

Toulon, , France

Las Vegas, Nevada, United States

Cordoba, Córdoba, Argentina

São Paulo, , Brazil

Münster, Nordrhein Westfalen, Germany

Ludwigshafen Am Rhein, Rheinland Pfalz, Germany

Pirna, Sachsen, Germany

Chuo Ku, Tokyo, Japan

Mito, Ibaraki, Japan

Bochum, Nordrhein Westfalen, Germany

Minneapolis, Minnesota, United States

Missoula, Montana, United States

Rosario, Santa Fe, Argentina

Fortaleza, Ceará, Brazil

Sao Paulo, São Paulo, Brazil

Las Vegas, Nevada, United States

Vitória, Espírito Santo, Brazil

Redmond, Washington, United States

Nagoya Shi, Aichi, Japan

Sapporo, Hokkaido, Japan

Naka, Ibaraki, Japan

Kamakura Shi, Kanagawa, Japan

Kashiwara, Osaka, Japan

Miyazaki, , Japan

Goiania, Goiás, Brazil

Petah Tikva, Hamerkaz, Israel

Austin, Texas, United States

Barcelona, Barcelona [Barcelona], Spain

Barcelona, Catalunya [Cataluña], Spain

Río Cuarto, , Argentina

Ushiku, Ibaraki, Japan

Santa Clarita, California, United States

Lima, Ohio, United States

Tel Aviv, Tell Abīb, Israel

Barcelona, Catalunya [Cataluña], Spain

Barcelona, Catalunya, Spain

Curitiba, Paraná, Brazil

Be'er Sheva, Hadarom, Israel

Beer Yaacov, Hamerkaz, Israel

Albany, New York, United States

New York, New York, United States

Ebina, Kanagawa, Japan

Kisarazu, Chiba, Japan

Shinjuku, Tokyo, Japan

São Paulo, , Brazil

Buffalo, New York, United States

Bad Mergentheim, , Germany

Córdoba, , Argentina

Torino, Piemonte, Italy

Ferrol, A Coruña [La Coruña], Spain

Fukuoka, , Japan

West Chester, Pennsylvania, United States

Strasbourg, Alsace, France

Norman, Oklahoma, United States

Mar Del Plata, Buenos Aires, Argentina

Santa Fe, , Argentina

Fortaleza, Ceará, Brazil

Le Creusot, Bourgogne, France

Vénissieux, Rhône Alpes, France

Lyon, , France

A Coruña, A Coruña [La Coruña], Spain

Roma, , Italy

Toulouse Cedex 9, Haute Garonne, France

Marseille, Bouches Du Rhône, France

Nantes Cedex 1, Loire Atlantique, France

Puebla, , Mexico

Herlev, Hovedstaden, Denmark

Dallas, Texas, United States

Ridgeland, Mississippi, United States

Río Cuarto, Córdoba, Argentina

Hamburg, , Germany

Monterrey, Nuevo León, Mexico

Karlsburg, Mecklenburg Vorpommern, Germany

Marseille, Bouches Du Rhône, France

Køge, , Denmark

Hachioji Shi, Tokyo, Japan

Sapporo, Hokkaido, Japan

Ciudad Autónoma De Buenos Aires, , Argentina

Padova, Veneto, Italy

Køge, Sjælland, Denmark

Petah Tikva, Hamerkaz, Israel

Vénissieux, , France

Decatur, Georgia, United States

Toulon, Provence Alpes Côte D'azur, France

Wylie, Texas, United States

Chihuahua, , Mexico

Sao Paulo, , Brazil

Bayamón, , Puerto Rico

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

A Coruña, , Spain

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Matsuyama, Ehime, Japan

Shizuoka City, Shizuoka, Japan

Pontoise, Val D'oise, France

Hacienda De Las Palmas, México, Mexico

Ciudad Autónoma De Buenos Aires, , Argentina

Catanzaro, , Italy

Pontoise, , France

Herning, Midtjylland, Denmark

Ciudad Autonoma De Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Santa Rosa, La Pampa, Argentina

Monterrey, Nuevo León, Mexico

Goleta, California, United States

Guadalajara, Jalisco, Mexico

West Des Moines, Iowa, United States

Covington, Kentucky, United States

Mckinney, Texas, United States

São Paulo, , Brazil

Hillerod, Hovedstaden, Denmark

Esbjerg, Syddanmark, Denmark

Caen, Basse Normandie, France

Lyon, Rhône Alpes, France

Bad Mergentheim, Baden Württemberg, Germany

Herzliya, Hamerkaz, Israel

Tel Aviv, Tell Abīb, Israel

Napoli, Campania, Italy

Nagoya, Aichi, Japan

Tama, Tokyo, Japan

Shimonoseki, Yamaguchi, Japan

Kumamoto, , Japan

Wakayama, , Japan

Tampico, Tamaulipas, Mexico

Ferrol, A Coruña, Spain

Esbjerg, Syddanmark, Denmark

Montpellier, , France

Cordoba, , Argentina

Fortaleza, , Brazil

Vitória, , Brazil

Ferrol, , Spain

Goiania, , Brazil

Curitiba, , Brazil

Buenos Aires, , Argentina

Fortaleza, , Brazil

Monterrey, , Mexico

Ciudad Autonoma De Buenos Aires, , Argentina

Hacienda De Las Palmas, , Mexico

Monterrey, , Mexico

Tel Aviv, , Israel

Patients applied

ML

1 patients applied

Trial Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Study Director

Eli Lilly and Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported