Trial Outcomes & Findings for A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices (NCT NCT05810597)
NCT ID: NCT05810597
Last Updated: 2024-10-15
Results Overview
PK: Cmax of Tirzepatide
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
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.
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Sequence 1: Tirzepatide by SDP / MUPFP
Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via a Single-Dose Pen (SDP) in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a Multi-use Prefilled Pen (MUPFP) in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
|
Sequence 2: Tirzepatide by MUPFP / SDP
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.
|
|---|---|---|
|
Period 1
STARTED
|
34
|
31
|
|
Period 1
Received At Least 1 Dose of Study Drug
|
34
|
31
|
|
Period 1
COMPLETED
|
31
|
31
|
|
Period 1
NOT COMPLETED
|
3
|
0
|
|
Period 2
STARTED
|
31
|
31
|
|
Period 2
Received At Least 1 Dose of Study Drug
|
31
|
31
|
|
Period 2
COMPLETED
|
31
|
31
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Tirzepatide by SDP / MUPFP
Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via a Single-Dose Pen (SDP) in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a Multi-use Prefilled Pen (MUPFP) in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations.
|
Sequence 2: Tirzepatide by MUPFP / SDP
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.
|
|---|---|---|
|
Period 1
Adverse Event
|
2
|
0
|
|
Period 1
Physician Decision
|
1
|
0
|
Baseline Characteristics
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
Baseline characteristics by cohort
| Measure |
Sequence 1: Tirzepatide by SDP / MUPFP
n=34 Participants
Participants received a single dose of 5 mg tirzepatide administered 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
n=31 Participants
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.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.10 years
STANDARD_DEVIATION 13.32 • n=99 Participants
|
41.10 years
STANDARD_DEVIATION 14.52 • n=107 Participants
|
41.10 years
STANDARD_DEVIATION 13.79 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.Population: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax of Tirzepatide
Outcome measures
| Measure |
Tirzepatide (SDP)
n=65 Participants
Participants received 5 mg tirzepatide SC via an SDP.
|
Tirzepatide (MUPFP)
n=62 Participants
Participants received 5 mg tirzepatide SC via a MUPFP.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide
|
647 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
524 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
PRIMARY outcome
Timeframe: 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.Population: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC(0-t) of Tirzepatide
Outcome measures
| Measure |
Tirzepatide (SDP)
n=65 Participants
Participants received 5 mg tirzepatide SC via an SDP.
|
Tirzepatide (MUPFP)
n=62 Participants
Participants received 5 mg tirzepatide SC via a MUPFP.
|
|---|---|---|
|
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
|
124000 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
118000 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: 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.Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
PK: AUC(0-∞) of Tirzepatide
Outcome measures
| Measure |
Tirzepatide (SDP)
n=65 Participants
Participants received 5 mg tirzepatide SC via an SDP.
|
Tirzepatide (MUPFP)
n=61 Participants
Participants received 5 mg tirzepatide SC via a MUPFP.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide
|
126000 ng*h/mL
Geometric Coefficient of Variation 22
|
119000 ng*h/mL
Geometric Coefficient of Variation 22
|
Adverse Events
Tirzepatide (SDP)
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Tirzepatide (MUPFP)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tirzepatide (SDP)
n=65 participants at risk
Participants received 5 mg tirzepatide SC via an SDP.
|
Tirzepatide (MUPFP)
n=62 participants at risk
Participants received 5 mg tirzepatide SC via a MUPFP.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
3/65 • Number of events 3 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
6.5%
4/62 • Number of events 4 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
10/65 • Number of events 10 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
11.3%
7/62 • Number of events 7 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
|
Gastrointestinal disorders
Nausea
|
24.6%
16/65 • Number of events 17 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
22.6%
14/62 • Number of events 15 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
9/65 • Number of events 9 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
11.3%
7/62 • Number of events 7 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
|
General disorders
Pain
|
6.2%
4/65 • Number of events 4 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
9.7%
6/62 • Number of events 6 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.2%
17/65 • Number of events 18 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
22.6%
14/62 • Number of events 14 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
|
Nervous system disorders
Headache
|
15.4%
10/65 • Number of events 11 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
8.1%
5/62 • Number of events 6 • Baseline Up To 82 Days
All participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60