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

Phase 3

Recruiting

• Conditions: Type 1 Diabetes; Obesity; Overweight
• Interventions: Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06914895
• 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 in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Study First Posted: 2025-04-06
• Study Start: 2025-04-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-05
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 905

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirzepatide Dose 1	Tirzepatide	Participants will receive tirzepatide subcutaneously (SC)
Tirzepatide Dose 2	Tirzepatide	Participants will receive tirzepatide SC
Tirzepatide Dose 3	Tirzepatide	Participants will receive tirzepatide SC
Tirzepatide Dose 4	Tirzepatide	Participants will receive tirzepatide 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 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
Percent Change from Baseline in Body Weight	Baseline, Week 40
Percentage of Participants with ≥5% Body Weight Reduction	Baseline, Week 40
Percentage of Participants with ≥10% Body Weight Reduction	Baseline, Week 40
Percentage of Participants with ≥15% Body Weight Reduction	Baseline, Week 40
Change from Baseline in Waist Circumference	Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 40
Percent Change from Baseline in Fasting Triglycerides	Baseline, Week 40
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol	Baseline, Week 40
Percent Change from Baseline in Total Daily Insulin Dose	Baseline, Week 40
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)	Baseline, Week 40
Change from Baseline in EQ-5D-5L	Baseline, Week 40
Change from Baseline in Body Weight	Baseline, Week 40

Trial Locations

Locations (148)

Sansum Diabetes Research Institute; 🇺🇸 Goleta, California, United States

Care Access - Santa Clarita; 🇺🇸 Santa Clarita, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

Orita Clinical Research; 🇺🇸 Decatur, Georgia, United States

North Georgia Clinical Research; 🇺🇸 Woodstock, Georgia, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

Rocky Mountain Clinical Research; 🇺🇸 Idaho Falls, Idaho, United States

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

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