Tirzepatide for Type 1 Diabetes and Obesity

(SURPASS-T1D-1 Trial)

Recruiting at147 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with type 1 diabetes who are also overweight or obese. Participants will be involved in the study for approximately 49 weeks.

Inclusion Criteria

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 an HbA1c value of 7.0% to 10.5% inclusive, at screening

Exclusion Criteria

Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization

I've been hospitalized twice for poor blood sugar control in the last 6 months.

I am being treated for diabetic eye problems.

Treatment Details

Interventions

• Tirzepatide (GLP-1 Receptor Agonist)

Trial Overview The study is testing the effectiveness and safety of a medication called Tirzepatide compared to a placebo, which has no active ingredients.

Participant Groups

Group I: Tirzepatide Dose 4 Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC

Group II: Tirzepatide Dose 3 Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC

Group III: Tirzepatide Dose 2 Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC

Group IV: Tirzepatide Dose 1 Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC)

Group V: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University