HealthyPhase 1NCT04311424

Study of Tirzepatide in Healthy Participants

A Phase 1 study testing 14C Tirzepatide in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 14C Tirzepatide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited Kingdom
Study dates: 28 Jul 2020to 2 Oct 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Ltd
Leeds, West Yorkshire, LS2 9LH

Other trials in United Kingdom

About this study

Official title: Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects

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.

Conditions: Healthy
Being tested: 14C Tirzepatide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

14C TirzepatideDrug
Also called LY3298176
Administered SC.

Study groups in NCT04311424
Study group	Role	What they receive
14C Tirzepatide	Experimental	A single dose of [14C]-tirzepatide administered subcutaneously (SC). Receives: Drug: 14C Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 20202 Oct 2020

First posted17 Mar 2020
Study start28 Jul 2020
Primary completion2 Oct 2020
Study completion2 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04311424
Sponsor's protocol ID: 17378
Other IDs: I8F-MC-GPHX, 2019-003664-44, 2019
Status last verified: Jun 2022
First submitted: 16 Mar 2020
Last updated: 24 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Disposition of [14C]-Tirzepatide Following Subcutaneous Administration in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04311424
Acronym / sponsor ID: 17378
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 28 Jul 2020 (actual)
Primary completion: 2 Oct 2020 (actual)
Study completion: 2 Oct 2020 (actual)
First posted: 17 Mar 2020 (actual)
Results: Posted 24 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
14C Tirzepatide	Experimental	Drug: 14C TirzepatideA single dose of [14C]-tirzepatide administered subcutaneously (SC).

Who may qualify

Ages: 30 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
14C TirzepatideAlso: LY3298176Administered SC.	Drug	14C Tirzepatide

Primary outcome

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

6 secondary outcomes

Total Number of Metabolites
Time frame: Pre-dose and up to 63 days post-dose
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)
Time frame: 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
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
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
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
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

Results and safety

Results posted to the registry on 24 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
[14C]-Tirzepatide	6	6

Primary outcome: 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. Mean (Standard Deviation). Unit: Percentage of the total radioactive dose

Measure	[14C]-Tirzepatide n = 6
Value	49.56 (2.58)

Population analysed: All randomized participants who received at least one dose of study drug.

Primary outcome: 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. Mean (Standard Deviation). Unit: Percentage of the total radioactive dose

Measure	[14C]-Tirzepatide n = 6
Value	20.46 (2.05)

Population analysed: All randomized participants who received at least one dose of study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To Day 64. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
[14C]-Tirzepatide	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 14C Tirzepatide in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.