A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
Launched by ELI LILLY AND COMPANY · May 6, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called tirzepatide, which is being tested for its effectiveness and safety in adults with type 1 diabetes who are also overweight or obese. The goal is to see how well this treatment works over a longer period of about 20 months. The study is not yet recruiting participants, but it will include adults between the ages of 65 and 74 who have been using insulin for at least a year and have a certain level of blood sugar control, indicated by a test called HbA1c.
To participate, individuals must have a body mass index (BMI) of 25 or higher and have maintained a stable weight for at least three months before joining the study. However, people who have had serious issues with blood sugar control, such as needing to go to the hospital for very high or low blood sugar, or those who have certain eye conditions or have used weight loss medications recently, will not be eligible. Participants can expect regular check-ins and monitoring during the study, helping to ensure their safety and the effectiveness of the treatment being tested.
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
West Palm Beach, Florida, United States
Badalona, , Spain
Barcelona, , Spain
Badajoz, , Spain
Madrid, , Spain
Sevilla, , Spain
Marseille, , France
Tustin, California, United States
Corbeil Essonnes, , France
Aurora, Colorado, United States
Chapel Hill, North Carolina, United States
Escondido, California, United States
Thessaloniki, , Greece
Mexico City, Distrito Federal, Mexico
Thessaloniki, , Greece
Grenoble, , France
Chesterfield, Missouri, United States
Houston, Texas, United States
Madrid, Madrid, Comunidad De, Spain
Guadalajara, Jalisco, Mexico
Grenoble, Isère, France
Corbeil Essonnes, île De France, France
Guadalajara, Jalisco, Mexico
Mesquite, Texas, United States
Round Rock, Texas, United States
Córdoba, , Argentina
São Paulo, , Brazil
Krnov, Moravskoslezský Kraj, Czechia
Praha, Praha 4, Czechia
Paleo Faliro, Attikí (Region), Greece
Henderson, Nevada, United States
Minneapolis, Minnesota, United States
Sao Paulo, São Paulo, Brazil
Rosario, Santa Fe, Argentina
Badalona, Barcelona [Barcelona], Spain
Thessaloniki, Thessaloníki, Greece
Weslaco, Texas, United States
Calgary, Alberta, Canada
Barcelona, Catalunya [Cataluña], Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Chrudim Iii, Chrudim, Czechia
Guadalajara, Jalisco, Mexico
Praha, Praha 8, Czechia
Paris, , France
Granadero Baigorria, Santa Fe, Argentina
Le Creusot, Bourgogne, France
Vénissieux, Rhône Alpes, France
Athens, Attikí, Greece
Baia Mare, Maramureș, Romania
Galați, , Romania
Iași, , Romania
Brasov, Brașov, Romania
Rio De Janeiro, , Brazil
Toulouse Cedex 9, Haute Garonne, France
Marseille, Bouches Du Rhône, France
Godoy Cruz, Mendoza, Argentina
Puebla, , Mexico
Campinas, São Paulo, Brazil
Dallas, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Fortaleza, Ceará, Brazil
Brasilia, Distrito Federal, Brazil
Hranice, Olomoucký Kraj, Czechia
Curitiba, Paraná, Brazil
Goiânia, Goiás, Brazil
Monterrey, Nuevo León, Mexico
Springfield, Missouri, United States
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Vénissieux, , France
Athens, , Greece
Surrey, British Columbia, Canada
Sherbrooke, Quebec, Canada
Chihuahua, , Mexico
Sao Paulo, , Brazil
Thessaloniki, Kentrikí Makedonía, Greece
Sydney, Nova Scotia, Canada
Olomouc, , Czechia
San Antonio, Texas, United States
Newport Beach, California, United States
Monterrey, Nuevo León, Mexico
West Des Moines, Iowa, United States
Bois Guillaume, Haute Normandie, France
Tampico, Tamaulipas, Mexico
Bucharest, București, Romania
Bonita, California, United States
San Miguel De Tucuman, Tucumán, Argentina
Ottawa, Ontario, Canada
Montréal, Quebec, Canada
Targoviste, Dâmbovița, Romania
Bucharest, Ilfov, Romania
București, , Romania
Buenos Aires, , Argentina
Curitiba, , Brazil
Krnov, , Czechia
Praha, , Czechia
Paleo Faliro, , Greece
Baia Mare, , Romania
Campinas, , Brazil
Praha, , Czechia
Brasov, , Romania
Fortaleza, , Brazil
Hranice, , Czechia
Goiânia, , Brazil
Monterrey, , Mexico
Monterrey, , Mexico
San Miguel De Tucuman, , Argentina
Bucharest, , Romania
Targoviste, , Romania
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