Trial · Interventional

CompletedPhase 1Results postedRegistry data

Study of Tirzepatide in Healthy Participants

NCTNCT04311424Other id17378Other idI8F-MC-GPHXOther id2019-003664-44Other id2019

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 6 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United Kingdom
Start: 28 Jul 2020
Primary completion: 2 Oct 2020
Completion: 2 Oct 2020
First posted: 17 Mar 2020
Last update posted: 24 Mar 2023
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20202021

Ph 1
Study of Tirzepatide in Healthy Participants
NCT04311424
28 Jul 2020 to 2 Oct 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 weeks, including screening.

Interventions

14C TirzepatideDrug

Arms1

Experimental
14C Tirzepatide
A single dose of \[14C\]-tirzepatide administered subcutaneously (SC).

Primary outcomes2

Outcomes the sponsor listed as primary.

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

Secondary outcomes(6)

Total Number of Metabolites
Time frame · Pre-dose and up to 63 days post-dose
Registry description
Total Number of Metabolites.
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)
Time frame · Pre-dose and up to 63 days post-dose
Registry description
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable).
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide
Time frame · Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
Registry description
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\[0-∞\]) of tirzepatide.
PK: Maximum Concentration (Cmax) of Tirzepatide
Time frame · Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
Registry description
PK: Maximum Concentration (Cmax) of tirzepatide.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity
Time frame · Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
Registry description
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC\[0-∞\]) of Total Radioactivity. Total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL).
PK: Maximum Concentration (Cmax) of Total Radioactivity
Time frame · Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose
Registry description
PK: Cmax of total radioactivity in plasma and whole blood. The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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

Group	Value (Percentage of the total radioactive dose)	Spread
[14C]-Tirzepatide	49.56	2.58

Primary outcomeMean· 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

Group	Value (Percentage of the total radioactive dose)	Spread
[14C]-Tirzepatide	20.46	2.05

Secondary and other outcome results(6)

Secondary outcomeNumber· Pre-dose and up to 63 days post-dose

Total Number of Metabolites

Group	Value (metabolites)
[14C]-Tirzepatide	4

Secondary outcomeMean· Pre-dose and up to 63 days post-dose

Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)

Group	Value (Percentage of the total radioactive dose)	Spread
[14C]-Tirzepatide	70.03	1.98

Secondary outcomeGeometric mean· Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide

Group	Value (nanogramhour per milliliter (ngh/mL))	Spread
[14C]-Tirzepatide	96100	13

Secondary outcomeGeometric mean· Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

PK: Maximum Concentration (Cmax) of Tirzepatide

Group	Value (ng/mL)	Spread
[14C]-Tirzepatide	453	29

Secondary outcomeGeometric mean· Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity

Group	Value (h*ng Eq/mL)	Spread
[14C]-Tirzepatide	87900	13

Secondary outcomeGeometric mean· Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

PK: Maximum Concentration (Cmax) of Total Radioactivity

Group	Value (ng Eq/mL)	Spread
[14C]-Tirzepatide	327	16

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
[14C]-TirzepatideParticipants received single dose of approximately 4.1 mg tirzepatide containing approximately 100 μCi of \[14C\]- tirzepatide administered as a subcutaneous injection.	0 / 6	0 / 6	6 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 30 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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 the study Exclusion Criteria: * Have known allergies to tirzepatide or related compounds * Have a medical condition or medical history that makes participation in the study unsafe or which may interfere in the interpretation of the results of the study * Have had exposure to significant radiation within 12 months prior to dosing (for example, multiple x-ray or computed tomography \[CT\] scans, barium meal, being employed in a job requiring radiation exposure monitoring) * Have participated in any clinical trial involving a radiolabeled substance within the past 12 months

PepBank is a research reference. Talk to a doctor before you use any peptide.