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14C Tirzepatide

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04311424Study of Tirzepatide in Healthy ParticipantsPHASE1 COMPLETED 6 — — Jul 28, 2020Oct 2, 2020Mar 24, 20231 United Kingdom
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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 — 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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