HealthyPhase 1NCT04004988
A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants
A Phase 1 study testing Tirzepatide, Prefilled syringe (PFS) and Auto-injector (AI) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
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 given as a solution formulation via an autoinjector versus a conventional prefilled syringe. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tirzepatide, Prefilled syringe (PFS) and Auto-injector (AI)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Aug 2019to 16 Dec 2019
- 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 21 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 18.0 and 32.0 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 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.
About this study
Official title: A Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by an Autoinjector Versus Prefilled Syringe in Healthy Subjects
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 given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected.
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 about 14 weeks, including screening.
- Conditions
- Healthy
- Being tested
- Tirzepatide, Prefilled syringe (PFS), Auto-injector (AI)
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
Prefilled syringe (PFS)Device
PFS used to administer tirzepatide
Auto-injector (AI)Device
AI used to administer tirzepatide
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide Test | Experimental | Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods. Receives: Drug: Tirzepatide; Device: Auto-injector (AI) |
| Tirzepatide Reference | Experimental | Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods. Receives: Drug: Tirzepatide; Device: Prefilled syringe (PFS) |
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 (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.
Measured: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported
Measured: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start19 Aug 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004988
- Sponsor's protocol ID
- 17105
- Other IDs
- I8F-MC-GPGS
- Status last verified
- 1 Apr 2023
- First submitted
- 28 Jun 2019
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by an Autoinjector Versus Prefilled Syringe in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04004988
- Acronym / sponsor ID
- 17105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected.
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 about 14 weeks, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide Test | Experimental | Drug: Tirzepatide, Device: Auto-injector (AI)Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods. |
| Tirzepatide Reference | Experimental | Drug: Tirzepatide, Device: Prefilled syringe (PFS)Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods. |
Who may qualify
- Ages
- 21 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 18.0 and 32.0 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 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: LY3298176Administered SC | Drug | Tirzepatide Reference, Tirzepatide Test |
| Prefilled syringe (PFS)PFS used to administer tirzepatide | Device | Tirzepatide Reference |
| Auto-injector (AI)AI used to administer tirzepatide | Device | Tirzepatide Test |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)
Time frame: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide
Time frame: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, Prefilled syringe (PFS) and Auto-injector (AI) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 18 Apr 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 Singapore. 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 18 Apr 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 (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf) (time frame: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose). 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?
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 18 Apr 2023.