Trial Outcomes & Findings for A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants (NCT NCT04004988)

Last Updated: 2023-04-18

Results Overview

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

47 participants

Primary outcome timeframe

Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence A Participants received single dose of 5 milligram (mg) tirzepatide by subcutaneous injection (SC) administered through autoinjector on day 1 of period 1. Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 2.	Sequence B Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 1. Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector on day 1 of period 2.
Period 1 STARTED	24	23
Period 1 Received at Least One Dose of Study Drug	22	23
Period 1 COMPLETED	21	20
Period 1 NOT COMPLETED	3	3
Period 2 STARTED	21	20
Period 2 Received at Least One Dose of Study Drug	21	20
Period 2 COMPLETED	21	20
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence A Participants received single dose of 5 milligram (mg) tirzepatide by subcutaneous injection (SC) administered through autoinjector on day 1 of period 1. Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 2.	Sequence B Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe on day 1 of period 1. Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector on day 1 of period 2.
Period 1 Physician Decision	2	0
Period 1 Withdrawal by Subject	0	1
Period 1 Adverse Event	1	2

Baseline Characteristics

A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=47 Participants Participants received 5mg of tirzepatide by SC injection administered by autoinjector or prefilled syringe on day 1 of each period as per the dosing sequence.
Age, Continuous	44.6 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	47 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Singapore	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.

Outcome measures

Outcome measures
Measure	5 mg Tirzepatide AI n=42 Participants Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector.	5 mg Tirzepatide PFS n=42 Participants Participants received single dose of 5mg tirzepatide by SC injection administered through prefilled syringe.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)	101000 Nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 18	104000 Nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 18

PRIMARY outcome

Timeframe: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

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

PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported

Outcome measures

Outcome measures
Measure	5 mg Tirzepatide AI n=42 Participants Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector.	5 mg Tirzepatide PFS n=44 Participants Participants received single dose of 5mg tirzepatide by SC injection administered through prefilled syringe.
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide	530 Nanogram per Milliliter (ng/mL) Geometric Coefficient of Variation 25	556 Nanogram per Milliliter (ng/mL) Geometric Coefficient of Variation 22

Adverse Events

5 mg Tirzepatide AI

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

5 mg Tirzepatide PFS

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5 mg Tirzepatide AI n=42 participants at risk Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector.	5 mg Tirzepatide PFS n=44 participants at risk Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe.
General disorders Catheter site phlebitis	0.00% 0/42 • Up to 72 days All participants who received at least one dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 72 days All participants who received at least one dose of study drug.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	5 mg Tirzepatide AI n=42 participants at risk Participants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector.	5 mg Tirzepatide PFS n=44 participants at risk Participants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe.
Gastrointestinal disorders Abdominal distension	47.6% 20/42 • Number of events 21 • Up to 72 days All participants who received at least one dose of study drug.	65.9% 29/44 • Number of events 34 • Up to 72 days All participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	7.1% 3/42 • Number of events 4 • Up to 72 days All participants who received at least one dose of study drug.	9.1% 4/44 • Number of events 4 • Up to 72 days All participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	9.5% 4/42 • Number of events 4 • Up to 72 days All participants who received at least one dose of study drug.	4.5% 2/44 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.
Gastrointestinal disorders Eructation	11.9% 5/42 • Number of events 6 • Up to 72 days All participants who received at least one dose of study drug.	18.2% 8/44 • Number of events 8 • Up to 72 days All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	33.3% 14/42 • Number of events 14 • Up to 72 days All participants who received at least one dose of study drug.	27.3% 12/44 • Number of events 13 • Up to 72 days All participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	33.3% 14/42 • Number of events 26 • Up to 72 days All participants who received at least one dose of study drug.	36.4% 16/44 • Number of events 31 • Up to 72 days All participants who received at least one dose of study drug.
General disorders Catheter site bruise	7.1% 3/42 • Number of events 4 • Up to 72 days All participants who received at least one dose of study drug.	13.6% 6/44 • Number of events 6 • Up to 72 days All participants who received at least one dose of study drug.
General disorders Catheter site erythema	9.5% 4/42 • Number of events 5 • Up to 72 days All participants who received at least one dose of study drug.	13.6% 6/44 • Number of events 6 • Up to 72 days All participants who received at least one dose of study drug.
General disorders Catheter site phlebitis	0.00% 0/42 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
General disorders Catheter site swelling	4.8% 2/42 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
General disorders Pain	0.00% 0/42 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
General disorders Vessel puncture site bruise	16.7% 7/42 • Number of events 8 • Up to 72 days All participants who received at least one dose of study drug.	4.5% 2/44 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.
General disorders Vessel puncture site phlebitis	7.1% 3/42 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.	4.5% 2/44 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/42 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	2.4% 1/42 • Number of events 1 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	57.1% 24/42 • Number of events 24 • Up to 72 days All participants who received at least one dose of study drug.	50.0% 22/44 • Number of events 22 • Up to 72 days All participants who received at least one dose of study drug.
Nervous system disorders Dizziness	7.1% 3/42 • Number of events 4 • Up to 72 days All participants who received at least one dose of study drug.	4.5% 2/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
Nervous system disorders Headache	19.0% 8/42 • Number of events 11 • Up to 72 days All participants who received at least one dose of study drug.	25.0% 11/44 • Number of events 12 • Up to 72 days All participants who received at least one dose of study drug.
Nervous system disorders Lethargy	7.1% 3/42 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.	4.5% 2/44 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.
Nervous system disorders Somnolence	4.8% 2/42 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	4.8% 2/42 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dry throat	7.1% 3/42 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.	2.3% 1/44 • Number of events 1 • Up to 72 days All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 3/42 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.	4.5% 2/44 • Number of events 2 • Up to 72 days All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/42 • Up to 72 days All participants who received at least one dose of study drug.	6.8% 3/44 • Number of events 3 • Up to 72 days All participants who received at least one dose of study drug.