HealthyPhase 1NCT05810597

A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

A Phase 1 study testing Tirzepatide, Single Dose Pen and Multi-use Prefilled Pen in people with Healthy, run by Eli Lilly and Company at 3 sites in United States.

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 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tirzepatide, Single Dose Pen and Multi-use Prefilled Pen
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 3 sitesUnited States
Study dates: 3 Apr 2023to 17 Jul 2023
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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening
Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
Are agreeable to receiving study treatment by injections under the skin
Are agreeable to following study contraception requirements

Who cannot join

Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Smoke more than the equivalent of 10 cigarettes per day
Is a known user of drugs of abuse

Trial locations and contacts

3 sites in 1 country.

United States3 sites

ICON
Salt Lake City, Utah, 84124
ICON Early Phase Services
San Antonio, Texas, 78209
Qps-Mra, Llc
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Bioequivalence Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants

The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.

Conditions: Healthy
Being tested: Tirzepatide, Single Dose Pen, Multi-use Prefilled Pen

What participants receive

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

TirzepatideDrug
Also called LY3298176
Administered SC
Single Dose PenDevice
Used to administer tirzepatide SC
Multi-use Prefilled PenDevice
Used to administer tirzepatide SC

Study groups in NCT05810597
Study group	Role	What they receive
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)	Experimental	Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. Receives: Drug: Tirzepatide; Device: Single Dose Pen; Device: Multi-use Prefilled Pen
Sequence 2: Tirzepatide by MUPFP / SDP	Experimental	Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations. Receives: Drug: Tirzepatide; Device: Single Dose Pen; Device: Multi-use Prefilled Pen

What is being measured

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide
PK: Cmax of Tirzepatide
Measured: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide
PK: AUC(0-t) of Tirzepatide
Measured: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide
PK: AUC(0-∞) of Tirzepatide
Measured: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

Timeline

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

3 Apr 202317 Jul 2023

First posted12 Apr 2023
Study start3 Apr 2023
Primary completion17 Jul 2023
Study completion17 Jul 2023

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05810597
Sponsor's protocol ID: 18698
Other IDs: I8F-MC-GPIP
Status last verified: 1 Jul 2024
First submitted: 31 Mar 2023
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
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?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants
ClinicalTrials.gov ID: NCT05810597
Acronym / sponsor ID: 18698
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 3 Apr 2023 (actual)
Primary completion: 17 Jul 2023 (actual)
Study completion: 17 Jul 2023 (actual)
First posted: 12 Apr 2023 (actual)
Results: Posted 15 Oct 2024

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)	Experimental	Drug: Tirzepatide, Device: Single Dose Pen, Device: Multi-use Prefilled PenParticipants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations.
Sequence 2: Tirzepatide by MUPFP / SDP	Experimental	Drug: Tirzepatide, Device: Single Dose Pen, Device: Multi-use Prefilled PenParticipants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening
Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
Are agreeable to receiving study treatment by injections under the skin
Are agreeable to following study contraception requirements

Key exclusion criteria (3 listed)

Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Smoke more than the equivalent of 10 cigarettes per day
Is a known user of drugs of abuse

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
TirzepatideAlso: LY3298176Administered SC	Drug	Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP), Sequence 2: Tirzepatide by MUPFP / SDP
Single Dose PenUsed to administer tirzepatide SC	Device	Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP), Sequence 2: Tirzepatide by MUPFP / SDP
Multi-use Prefilled PenUsed to administer tirzepatide SC	Device	Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP), Sequence 2: Tirzepatide by MUPFP / SDP

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: Cmax of Tirzepatide
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: AUC(0-t) of Tirzepatide
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
PK: AUC(0-∞) of Tirzepatide

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Tirzepatide by SDP / MUPFP	34	31
Sequence 2: Tirzepatide by MUPFP / SDP	31	31

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide

Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Tirzepatide (SDP) n = 65	Tirzepatide (MUPFP) n = 62
Value	647 (31)	524 (27)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide

Measure	Tirzepatide (SDP) n = 65	Tirzepatide (MUPFP) n = 62
Value	124000 (23)	118000 (22)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide

Measure	Tirzepatide (SDP) n = 65	Tirzepatide (MUPFP) n = 61
Value	126000 (22)	119000 (22)

Population analysed: All participants who received at least one dose of study drug and had evaluable data for this outcome.

Adverse events

Time frame: Baseline Up To 82 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tirzepatide (SDP)	0 of 65 (0%)	38 of 65 (58.5%)	0 of 65
Tirzepatide (MUPFP)	0 of 62 (0%)	28 of 62 (45.2%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tirzepatide, Single Dose Pen and Multi-use Prefilled Pen in people with Healthy, run by Eli Lilly and Company at 3 sites in United States.

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 5 inclusion and 3 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 15 Oct 2024). 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?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide (time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.). The study lists 3 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 NCT05810597.

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 15 Oct 2024.