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14C Tirzepatide

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Mar 24, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

14C Tirzepatide · 1 trial · 1 indication

Phase 1 1
NCT04311424Study of Tirzepatide in Healthy ParticipantsHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
Study of Tirzepatide in Healthy Participants
Healthy
NCT043114246
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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 used for?

14C Tirzepatide is an investigational small molecule being studied in healthy participants. It is a radiolabeled form of tirzepatide used in a Phase 1 clinical trial to evaluate its pharmacokinetics and metabolism in the body. The drug is not approved for any medical condition and remains in clinical development.

Who makes 14C Tirzepatide?

14C Tirzepatide is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research on this investigational drug in healthy volunteers.

What phase is 14C Tirzepatide in?

14C Tirzepatide is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing.

What clinical trials is 14C Tirzepatide in?

14C Tirzepatide was studied in one completed Phase 1 clinical trial, registered as NCT04311424, titled "Study of Tirzepatide in Healthy Participants." The trial enrolled 6 healthy male participants aged 30 years and older in the United Kingdom and was uncontrolled, meaning there was no comparator group.

Is 14C Tirzepatide the same as tirzepatide?

14C Tirzepatide is a radiolabeled version of tirzepatide, where the carbon-14 isotope is incorporated into the molecule. This labeling allows researchers to track the drug's absorption, distribution, metabolism, and excretion in the body during early-phase clinical studies.