Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Healthy Lactating Females (NCT NCT05978713)
NCT ID: NCT05978713
Last Updated: 2025-04-27
Results Overview
PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose
Results posted on
2025-04-27
Participant Flow
Participant milestones
| Measure |
5 mg Tirzepatide
Participants received a single dose of 5 mg tirzepatide injection administered subcutaneously (SC).
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
Received a Dose of Tirzepatide
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
Baseline characteristics by cohort
| Measure |
5 mg Tirzepatide
n=11 Participants
Participants received a single dose of 5 mg tirzepatide injection administered SC.
|
|---|---|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 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
United States
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dosePopulation: Participants who received a dose of tirzepatide were eligible for this outcome analysis.
PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk
Outcome measures
| Measure |
5 mg Tirzepatide
n=11 Participants
Participants received a single dose of 5 mg tirzepatide injection administered SC.
|
|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])
|
NA nanogram*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
For all participants, insufficient quantifiable concentrations, due to data below the level of detection, were available after the maximum observed drug concentration (Cmax) to calculate the elimination phase parameters for breastmilk. Therefore, AUC(0-∞) in breastmilk was not calculated.
|
Adverse Events
5 mg Tirzepatide
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5 mg Tirzepatide
n=11 participants at risk
Participants received a single dose of 5 mg tirzepatide injection administered SC.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.2%
2/11 • Number of events 3 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Abdominal distension
|
27.3%
3/11 • Number of events 3 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Diarrhoea
|
63.6%
7/11 • Number of events 7 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Nausea
|
81.8%
9/11 • Number of events 10 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
4/11 • Number of events 4 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
General disorders
Fatigue
|
36.4%
4/11 • Number of events 5 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Immune system disorders
Seasonal allergy
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
90.9%
10/11 • Number of events 10 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
2/11 • Number of events 2 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Nervous system disorders
Headache
|
45.5%
5/11 • Number of events 5 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Nervous system disorders
Lethargy
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Psychiatric disorders
Abnormal dreams
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 29)
All enrolled participants who received a dose of Tirzepatide.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60