HealthyPhase 1NCT03375463

A Study of Tirzepatide (LY3298176) in Healthy Participants

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.

Trial summary

This study has four parts. Each participant will enroll in one part. Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Read more about this study

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?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 19 Dec 2017to 27 Dec 2018
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

Overtly healthy males or females, as determined by medical history and physical examination
Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product
Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state
Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive

Who cannot join

Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening
Have a history of heart block, or a pulse rate (PR) interval greater than (>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects

This study has four parts. Each participant will enroll in one part.

Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it.

Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein.

Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution.

Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation.

This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study.

Conditions: Healthy
Being tested: Tirzepatide, Placebo

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
TirzepatideDrug
Also called LY3298176
Administered IV
PlaceboDrug
Administered SC
TirzepatideDrug
Also called LY3298176
Administered IV

Study groups in NCT03375463
Study group	Role	What they receive
5 mg Tirzepatide SC (Solution)-Part A	Experimental	Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation. Receives: Drug: Tirzepatide
5 mg Tirzepatide SC (Lyophilized)-Part A	Experimental	Participants received 5 mg of tirzepatide SC lyophilized formulation. Receives: Drug: Tirzepatide
0.5 mg LY3298176 IV-Part B	Experimental	Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide formulation. Receives: Drug: Tirzepatide
5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C	Experimental	Participants received tirzepatide subcutaneous solution at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4). Receives: Drug: Tirzepatide
Placebo SC-Part C	Placebo comparator	Participants received SC injection of placebo. Receives: Drug: Placebo
0.5 mg LY3298176 Bolus IV-Part D	Experimental	Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation. Receives: Drug: Tirzepatide

What is being measured

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

Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
Pharmacokinetics (PK) Part A: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide.
Measured: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose
PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide.
Measured: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose
PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
PK Part B: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide.
Measured: Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose

Secondary outcomes (3)

PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide
PK Part C: Area under the concentration versus time curve during one dosing interval (168 hours) [AUC (0-τ)] of tirzepatide.
Measured: Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose
PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
PK Part C: Maximum observed plasma drug concentration (Cmax) of tirzepatide.
Measured: Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose
PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
PK Part D: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide.
Measured: Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose

Timeline

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

19 Dec 201727 Dec 2018

First posted18 Dec 2017
Study start19 Dec 2017
Primary completion27 Dec 2018
Study completion27 Dec 2018

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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03375463
Sponsor's protocol ID: 16671
Other IDs: I8F-MC-GPGE
Status last verified: Feb 2024
First submitted: 13 Dec 2017
Last updated: 5 Feb 2024
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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects
ClinicalTrials.gov ID: NCT03375463
Acronym / sponsor ID: 16671
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 19 Dec 2017 (actual)
Primary completion: 27 Dec 2018 (actual)
Study completion: 27 Dec 2018 (actual)
First posted: 18 Dec 2017 (actual)
Results: Posted 5 Feb 2024

Clinical summary

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

This study has four parts. Each participant will enroll in one part.

Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein.

Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution.

Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
5 mg Tirzepatide SC (Solution)-Part A	Experimental	Drug: TirzepatideParticipants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation.
5 mg Tirzepatide SC (Lyophilized)-Part A	Experimental	Drug: TirzepatideParticipants received 5 mg of tirzepatide SC lyophilized formulation.
0.5 mg LY3298176 IV-Part B	Experimental	Drug: TirzepatideParticipants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide formulation.
5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C	Experimental	Drug: TirzepatideParticipants received tirzepatide subcutaneous solution at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4).
Placebo SC-Part C	Placebo comparator	Drug: PlaceboParticipants received SC injection of placebo.
0.5 mg LY3298176 Bolus IV-Part D	Experimental	Drug: TirzepatideParticipants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.

Who may qualify

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

Key inclusion criteria (4 listed)

Overtly healthy males or females, as determined by medical history and physical examination
Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product
Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state
Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive

Key exclusion criteria (4 listed)

Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening
Have a history of heart block, or a pulse rate (PR) interval greater than (>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data

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	5 mg Tirzepatide SC (Lyophilized)-Part A, 5 mg Tirzepatide SC (Solution)-Part A, 5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C
TirzepatideAlso: LY3298176Administered IV	Drug	0.5 mg LY3298176 IV-Part B
PlaceboAdministered SC	Drug	Placebo SC-Part C
TirzepatideAlso: LY3298176Administered IV	Drug	0.5 mg LY3298176 Bolus IV-Part D

Primary outcome

Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
Time frame: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose
Pharmacokinetics (PK) Part A: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide.
PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
Time frame: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose
PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide.
PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
Time frame: Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose
PK Part B: Area under the concentration versus time curve [AUC (0-∞)] of tirzepatide.

3 secondary outcomes

PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide
Time frame: Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose
PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
Time frame: Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdose
PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
Time frame: Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdose

Results and safety

Results posted to the registry on 5 Feb 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-Part A	10	10
Sequence 2-Part A	10	10
0.5 mg Tirzepatide IV-Part B	8	7
Placebo SC-Part C	4	4
5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C	12	11
0.5 mg Tirzepatide Bolus IV-Part D	8	8

Primary outcome: Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter(ng*hr/mL)

Measure	5 mg Tirzepatide SC (Lyophilized)-Part A n = 19	5 mg Tirzepatide SC (Solution)-Part A n = 20
Value	113000 (19)	109000 (17)

Population analysed: All randomized participants from Part A group, who received at least one dose of study drug and had evaluable PK data

Primary outcome: PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

Time frame: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	5 mg Tirzepatide SC (Lyophilized)-Part A n = 20	5 mg Tirzepatide SC (Solution)-Part A n = 20
Value	524 (27)	575 (22)

Population analysed: All randomized participants from Part A group, who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide

Time frame: Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	0.5 mg Tirzepatide IV-Part B n = 8
Value	6680 (26)

Population analysed: All randomized participants from Part B group, who received at least one dose of study drug and had evaluable PK data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 92 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5 mg Tirzepatide SC (Lyophilized)-Part A	0 of 20 (0%)	9 of 20 (45%)	0 of 20
5 mg Tirzepatide SC (Solution)-Part A	0 of 20 (0%)	5 of 20 (25%)	0 of 20
0.5 mg Tirzepatide IV-Part B	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Placebo SC-Part C	0 of 4 (0%)	1 of 4 (25%)	0 of 4
5 mg Tirzepatide SC, First-Part C	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
5 mg Tirzepatide SC, Second Dose-Part C	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
7.5 mg LY3298176 SC-Part C	0 of 12 (0%)	6 of 12 (50%)	0 of 12
10 mg Tirzepatide SC-Part C	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11
0.5 mg Tirzepatide Bolus IV-Part D	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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

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 4 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 5 Feb 2024. 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. Some participants in this study may receive a placebo. 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 5 Feb 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) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide (time frame: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose). 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 NCT03375463.

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 5 Feb 2024.