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 25, 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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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