HealthyPhase 1NCT04050670

A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

A Phase 1 study testing Tirzepatide in people with Healthy, run by Eli Lilly and Company at 1 site 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 13 Sep 2019to 3 Apr 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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
Are agreeable to receiving study treatment by injections under the skin

Who cannot join

Have known allergies to tirzepatide or related compounds
Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
Have a prior history of malignant disease(s) in the past 5 years prior to screening
Smoke more than the equivalent of 10 cigarettes per day
Is a known user of drugs of abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Inc
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.

Conditions: Healthy
Being tested: Tirzepatide

What participants receive

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

TirzepatideDrug
Also called LY3298176
Tirzepatide administered SC

Study groups in NCT04050670
Study group	Role	What they receive
Tirzepatide - Upper Arm	Experimental	Participants received 5mg Tirzepatide by subcutaneous injection on upper arm. Receives: Drug: Tirzepatide
Tirzepatide - Thigh	Experimental	Participants received 5mg Tirzepatide by subcutaneous injection on thigh. Receives: Drug: Tirzepatide
Tirzepatide - Abdomen	Active comparator	Participants received 5mg Tirzepatide by subcutaneous injection on abdomen. Receives: Drug: Tirzepatide

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) was evaluated.
Measured: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
PK: Maximum Concentration (Cmax) of Tirzepatide
PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated.
Measured: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose

Timeline

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

13 Sep 20193 Apr 2020

First posted8 Aug 2019
Study start13 Sep 2019
Primary completion3 Apr 2020
Study completion3 Apr 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04050670
Sponsor's protocol ID: 17224
Other IDs: I8F-MC-GPHI
Status last verified: Apr 2023
First submitted: 7 Aug 2019
Last updated: 6 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices
ClinicalTrials.gov ID: NCT04050670
Acronym / sponsor ID: 17224
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 13 Sep 2019 (actual)
Primary completion: 3 Apr 2020 (actual)
Study completion: 3 Apr 2020 (actual)
First posted: 8 Aug 2019 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Tirzepatide - Upper Arm	Experimental	Drug: TirzepatideParticipants received 5mg Tirzepatide by subcutaneous injection on upper arm.
Tirzepatide - Thigh	Experimental	Drug: TirzepatideParticipants received 5mg Tirzepatide by subcutaneous injection on thigh.
Tirzepatide - Abdomen	Active comparator	Drug: TirzepatideParticipants received 5mg Tirzepatide by subcutaneous injection on abdomen.

Who may qualify

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

Key inclusion criteria (3 listed)

Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
Are agreeable to receiving study treatment by injections under the skin

Key exclusion criteria (6 listed)

Have known allergies to tirzepatide or related compounds
Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
Have a prior history of malignant disease(s) in the past 5 years prior to screening
Smoke more than the equivalent of 10 cigarettes per day

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: LY3298176Tirzepatide administered SC	Drug	Tirzepatide - Abdomen, Tirzepatide - Thigh, Tirzepatide - Upper Arm

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) was evaluated.
PK: Maximum Concentration (Cmax) of Tirzepatide
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated.

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
Sequence 1	18	18
Sequence 2	18	18
Sequence 3	18	18

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

Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: Hour * nanogram per milliliter (h*ng/mL)

Measure	Tirzepatide - Abdomen n = 54	Tirzepatide - Upper Arm n = 54	Tirzepatide - Thigh n = 53
Value	112000 (24)	111000 (21)	106000 (22)

Tirzepatide - Abdomen vs Tirzepatide - Thigh: Ratio of geometric least squares mean: 0.953 (90% CI 0.935 to 0.970), Linear mixed effects model
Tirzepatide - Abdomen vs Tirzepatide - Upper Arm: Ratio of geometric least squares mean: 0.990 (90% CI 0.972 to 1.01), Linear mixed effects model

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

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

Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram per Millilitre (ng/mL)

Measure	Tirzepatide - Abdomen n = 54	Tirzepatide - Upper Arm n = 54	Tirzepatide - Thigh n = 53
Value	603 (25)	556 (23)	520 (21)

Tirzepatide - Abdomen vs Tirzepatide - Thigh: Ratio of geometric least squares mean: 0.862 (90% CI 0.818 to 0.909), Linear mixed effects model
Tirzepatide - Abdomen vs Tirzepatide - Upper Arm: Ratio of geometric least squares mean: 0.921 (95% CI 0.874 to 0.971), Linear mixed effects model

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

Adverse events

Time frame: Up to 36 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tirzepatide - Abdomen	0 of 54 (0%)	37 of 54 (68.5%)	0 of 54
Tirzepatide - Upper Arm	0 of 54 (0%)	31 of 54 (57.4%)	0 of 54
Tirzepatide - Thigh	0 of 53 (0%)	23 of 53 (43.4%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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 Tirzepatide in people with Healthy, run by Eli Lilly and Company at 1 site 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 3 inclusion and 6 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 6 May 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 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 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?

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) (time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours 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 NCT04050670.

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 6 May 2023.