Trial Outcomes & Findings for A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes (NCT NCT04050670)
NCT ID: NCT04050670
Last Updated: 2023-05-06
Results Overview
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC\[0-∞\]) was evaluated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
Results posted on
2023-05-06
Participant Flow
There was a washout period of at least 35 days between Tirzepatide injections.
Participant milestones
| Measure |
Sequence 1
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on upper arm in period 1, on thigh in period 2 and on abdomen in period 3.
|
Sequence 2
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on abdomen in period 1, on upper arm in period 2 and on thigh in period 3.
|
Sequence 3
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on thigh in period 1, on abdomen in period 2 and on upper arm in period 3.
|
|---|---|---|---|
|
Period 1
STARTED
|
18
|
18
|
18
|
|
Period 1
Received at Least One Dose of Study Drug
|
18
|
18
|
18
|
|
Period 1
COMPLETED
|
18
|
18
|
18
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2
STARTED
|
18
|
18
|
18
|
|
Period 2
Received at Least One Dose
|
18
|
18
|
18
|
|
Period 2
COMPLETED
|
18
|
18
|
18
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 3
STARTED
|
18
|
18
|
18
|
|
Period 3
Received at Least One Dose
|
18
|
17
|
18
|
|
Period 3
COMPLETED
|
18
|
17
|
18
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on upper arm in period 1, on thigh in period 2 and on abdomen in period 3.
|
Sequence 2
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on abdomen in period 1, on upper arm in period 2 and on thigh in period 3.
|
Sequence 3
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection on thigh in period 1, on abdomen in period 2 and on upper arm in period 3.
|
|---|---|---|---|
|
Period 3
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes
Baseline characteristics by cohort
| Measure |
All Participants
n=54 Participants
Participants received 5mg Tirzepatide by subcutaneous injection administered through either upper arms or abdomen or thigh as per the dosing sequence.
|
|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 12.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
54 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dosePopulation: 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 of Tirzepatide From Time Zero to Infinity (AUC\[0-∞\]) was evaluated.
Outcome measures
| Measure |
Tirzepatide - Abdomen
n=54 Participants
Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.
|
Tirzepatide - Upper Arm
n=54 Participants
Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
|
Tirzepatide - Thigh
n=53 Participants
Participants received 5mg Tirzepatide by subcutaneous injection on thigh.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])
|
112000 Hour * nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 24
|
111000 Hour * nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 21
|
106000 Hour * nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK samples.
PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated.
Outcome measures
| Measure |
Tirzepatide - Abdomen
n=54 Participants
Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.
|
Tirzepatide - Upper Arm
n=54 Participants
Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
|
Tirzepatide - Thigh
n=53 Participants
Participants received 5mg Tirzepatide by subcutaneous injection on thigh.
|
|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Tirzepatide
|
603 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 25
|
556 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 23
|
520 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 21
|
Adverse Events
Tirzepatide - Abdomen
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Tirzepatide - Upper Arm
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Tirzepatide - Thigh
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tirzepatide - Abdomen
n=54 participants at risk
Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.
|
Tirzepatide - Upper Arm
n=54 participants at risk
Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
|
Tirzepatide - Thigh
n=53 participants at risk
Participants received 5mg Tirzepatide by subcutaneous injection on thigh.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
14.8%
8/54 • Number of events 8 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
18.5%
10/54 • Number of events 10 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
15.1%
8/53 • Number of events 8 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
4/54 • Number of events 4 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
3.7%
2/54 • Number of events 3 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
3.8%
2/53 • Number of events 2 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
3/54 • Number of events 3 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
3.7%
2/54 • Number of events 2 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.5%
10/54 • Number of events 11 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
20.4%
11/54 • Number of events 13 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
11.3%
6/53 • Number of events 7 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
5.6%
3/54 • Number of events 3 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
7.4%
4/54 • Number of events 5 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
3/54 • Number of events 3 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
1.9%
1/54 • Number of events 1 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
1.9%
1/53 • Number of events 1 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
37.0%
20/54 • Number of events 21 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
22.2%
12/54 • Number of events 12 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
20.8%
11/53 • Number of events 12 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
9/54 • Number of events 10 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
18.5%
10/54 • Number of events 10 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
7.5%
4/53 • Number of events 4 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
3.7%
2/54 • Number of events 2 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/54 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
5.7%
3/53 • Number of events 3 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.1%
13/54 • Number of events 13 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
13.0%
7/54 • Number of events 7 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
5.7%
3/53 • Number of events 3 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
22.2%
12/54 • Number of events 14 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
14.8%
8/54 • Number of events 8 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
11.3%
6/53 • Number of events 7 • Up to 36 days
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER