A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight (SURPASS-T1D-1)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight; Type 1 Diabetes; Obesity

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06914895

I8F-MC-GPJA (Other Identifier)

27285

2024-519684-17-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 905 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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905 participants in 5 patient groups, including a placebo group

Tirzepatide Dose 1

Experimental group

Description:

Participants will receive tirzepatide subcutaneously (SC)

Treatment:

Drug: Tirzepatide

Tirzepatide Dose 2

Experimental group

Description:

Participants will receive tirzepatide SC

Treatment:

Drug: Tirzepatide

Tirzepatide Dose 3

Experimental group

Description:

Participants will receive tirzepatide SC

Treatment:

Drug: Tirzepatide

Tirzepatide Dose 4

Experimental group

Description:

Participants will receive tirzepatide SC

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo