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Tirzepatide Dose 1

Phase 3

Type2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 26, 2025

Target and mechanism

Molecular targetGLP1R, GIPR
Target classAgonist
ModalitySmall molecule

Also known as Tirzepatide

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

Tirzepatide Dose 1 · 1 trial · 8 indications

Phase 3 1
NCT05260021A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or BothType2 Diabetes
COMPLETED99 Analytics
PHASE3COMPLETED
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
Type2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

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

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)

Secondary Endpoints

Change From Baseline in HbA1c (Individual Doses)
Baseline, Week 30
Percentage of Participants Who Achieve ≤6.5% of HbA1c
Week 30
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)
Baseline, Week 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tirzepatide Dose 1EXPERIMENTALDouble-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
Tirzepatide Dose 2EXPERIMENTALDouble-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
PlaceboPLACEBO_COMPARATORDouble-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.

Interventions

NameTypeDescription
Tirzepatide Dose 1DRUGAdministered SC
Tirzepatide Dose 2DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range10 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites51

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%...

Countries:United StatesAustraliaBrazilFranceIndiaIsraelItalyMexicoUnited Kingdom
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Frequently asked questions about Tirzepatide Dose 1

What is Tirzepatide used for?

Tirzepatide is being studied for use in obesity, overweight, obstructive sleep apnea, type 1 diabetes, hepatic insufficiency, and renal insufficiency. It is also being investigated in a master protocol for metabolic dysfunction-associated steatotic liver disease. The drug is currently in Phase 2 development for these conditions.

What does Tirzepatide target?

Tirzepatide is a peptide-based small molecule. It is being developed by Eli Lilly and Company for metabolic and weight-related conditions. The drug is in clinical trials for obesity, overweight, and other indications, with ongoing studies in adults and adolescents.

Who makes Tirzepatide?

Eli Lilly and Company (NYSE: LLY) is developing Tirzepatide. The company is conducting clinical trials of the drug across multiple indications, including obesity, overweight, and metabolic dysfunction-associated steatotic liver disease. Tirzepatide is currently in Phase 2 development.

What phase is Tirzepatide in?

Tirzepatide is in Phase 2 development. While some of its clinical trials are in Phase 3, the overall development stage for the drug is listed as Phase 2. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is Tirzepatide in?

Tirzepatide is being studied in several trials, including NCT05556512, a Phase 3 study on morbidity and mortality in adults with obesity, and NCT06075667, a Phase 3 study in adolescents with obesity or overweight. It is also part of NCT07165028, a master protocol in metabolic dysfunction-associated steatotic liver disease.

Is Tirzepatide the same as LY3298176?

Yes, Tirzepatide is also known as LY3298176. Clinical trials such as NCT03482024, a study in participants with impaired kidney function, use the LY3298176 name for the drug. Both names refer to the same investigational compound developed by Eli Lilly.