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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eli Lilly and Company
Study ID
NCT05260021
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 13, 2022
Status verified
Sep 2025
Primary completion
Jul 30, 2024
Completion
Jan 28, 2025

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide Dose 1
    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
  • Experimental: Tirzepatide Dose 2
    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
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg) [ Time Frame: Baseline, Week 30 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Center Of Excellence in Diabetes and EndocrinologySacramentoCalifornia95821-
Rady Children's HospitalSan DiegoCalifornia92123-
Touro University CaliforniaVallejoCalifornia94592-
Children's Hospital ColoradoAuroraColorado80045-
Nemours Children's Health - DelawareWilmingtonDelaware19803-
Qualmedica Research, LLCEvansvilleIndiana47715-
Indiana University Health University HospitalIndianapolisIndiana46202-
AA Medical Research CenterFlintMichigan48504-
Washington University School of MedicineSt LouisMissouri63110-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104-
Consano Clinical Research, LLCShavano ParkTexas78231-

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital Los Angeles· Los Angeles, CACenter Of Excellence in Diabetes and Endocrinology· Sacramento, CARady Children's Hospital· San Diego, CATouro University California· Vallejo, CAChildren's Hospital Colorado· Aurora, CONemours Children's Health - Delaware· Wilmington, DE

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