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14C Tirzepatide

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Mar 24, 2023

14C Tirzepatide development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2020

14C Tirzepatide target and mechanism

ModalitySmall molecule

Also known as LY3298176

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

14C Tirzepatide clinical trials

14C Tirzepatide · 1 trial · 1 indication

Phase 1 1
NCT04311424Study of Tirzepatide in Healthy ParticipantsHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
Study of Tirzepatide in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Pre-dose and up to 63 days post-dose

Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.

Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Pre-dose and up to 63 days post-dose

Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.

Secondary Endpoints

Total Number of Metabolites
Pre-dose and up to 63 days post-dose
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)
Pre-dose and up to 63 days post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide
Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
14C TirzepatideEXPERIMENTALA single dose of \[14C\]-tirzepatide administered subcutaneously (SC).

Interventions

NameTypeDescription
14C TirzepatideDRUGAdministered SC.
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Eligibility Criteria

Age Range30 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy males as determined by medical history, physical examination, and other screening procedures * Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening * Are willing to be available for the full duration of t...

Countries:United Kingdom
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Frequently asked questions about 14C Tirzepatide

What is 14C Tirzepatide?

14C Tirzepatide is a carbon-14 labeled version of tirzepatide, a small molecule therapeutic developed by Eli Lilly and Company. It is used in clinical research to study the absorption, distribution, metabolism, and excretion of tirzepatide in the body. The drug is in Phase 1 development.

Who makes 14C Tirzepatide?

14C Tirzepatide is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Eli Lilly is the sole developer listed for this asset.

What phase is 14C Tirzepatide in?

14C Tirzepatide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is 14C Tirzepatide in?

14C Tirzepatide has been studied in one completed Phase 1 trial, NCT04311424, titled "Study of Tirzepatide in Healthy Participants." The trial enrolled 6 healthy male participants aged 30 years and older in the United Kingdom. It was an uncontrolled study without randomization or double-blinding.

What is 14C Tirzepatide used for?

14C Tirzepatide is used as a research tool in clinical trials to investigate the pharmacokinetics of tirzepatide, including its metabolism and excretion. The specific therapeutic indications for this labeled version are undisclosed. The completed Phase 1 trial was conducted in healthy participants.