A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both (SURPASS-PEDS)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Type2 Diabetes; Glucose Metabolism Disorders; Diabetes Mellitus; Metabolic Disease; Diabetes Mellitus, Type 2; T2D; Endocrine System Diseases; T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: Placebo; Drug: Tirzepatide Dose 2; Drug: Tirzepatide Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05260021

17121

I8F-MC-GPGV (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.

The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

Enrollment: 99 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 10 to below 18 years at screening visit
• Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
• Have HbA1c >6.5% to ≤11% at screening
• Have body weight ≥50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region.

Exclusion criteria

• Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
• After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
• Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
• Had chronic or acute pancreatitis any time prior to study entry
• Female participants who are pregnant or breast feeding or intending to become pregnant.
• Using prescription or over the counter medications for weight loss within 90 days of the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 3 patient groups, including a placebo group

Tirzepatide Dose 1

Experimental group

Description:

Double-Blind: Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level

Treatment:

Drug: Tirzepatide Dose 1

Tirzepatide Dose 2

Experimental group

Description:

Double-Blind: Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level

Treatment:

Drug: Tirzepatide Dose 2

Placebo

Placebo Comparator group

Description:

Double-Blind: Participants receive placebo during the 30-week double-blind period. Open-Label: Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.

Treatment:

Drug: Tirzepatide Dose 1

Drug: Placebo