A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
- Conditions
- Type 1 DiabetesObesityOverweight
- Interventions
- Drug: Placebo
- Registration Number
- NCT06962280
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 465
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will receive tirzepatide subcutaneously (SC) Placebo Placebo Participants will receive placebo SC
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percentage of Participants with ≥5% Body Weight Reduction Baseline, Week 40, Week 72 Percentage of Participants with ≥10% Body Weight Reduction Baseline, Week 40, Week 72 Percentage of Participants with ≥15% Body Weight Reduction Baseline, Week 40, Week 72 Change from Baseline in Waist Circumference Baseline, Week 40, Week 72 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 40, Week 72 Percent Change from Baseline in Total Daily Insulin Dose Baseline, Week 40, Week 72 Change from Baseline in EQ-5D-5L Baseline, Week 40, Week 72 Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L)) Inclusive, Per Day Within 30 days prior to Week 40, Within 30 days prior to Week 72 Change from Baseline in Body Weight Baseline, Week 40, Week 72 Percent Change from Baseline in Body Weight Baseline, Week 40, Week 72 Change from Baseline in HbA1c Baseline, Week 72 Percent Change from Baseline in Fasting Triglycerides Baseline, Week 40, Week 72 Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol Baseline, Week 40, Week 72 Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Baseline, Week 40, Week 72
Trial Locations
- Locations (81)
Kaiser Permanente Bonita Medical Offices
🇺🇸Bonita, California, United States
AMCR Institute
🇺🇸Escondido, California, United States
Mary & Dick Allen Diabetes Center
🇺🇸Newport Beach, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
HealthPartners Institute dba International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Clinvest Headlands Llc
🇺🇸Springfield, Missouri, United States
Scroll for more (71 remaining)Kaiser Permanente Bonita Medical Offices🇺🇸Bonita, California, United StatesPatricia WuPrincipal Investigator