Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function (NCT NCT03482024)
NCT ID: NCT03482024
Last Updated: 2023-03-23
Results Overview
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC\[0-tlast\]) of Tirzepatide was evaluated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
Results posted on
2023-03-23
Participant Flow
Participant milestones
| Measure |
Tirzepatide - Control
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection.
|
Tirzepatide - Mild Renal Impairment
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Moderate Renal Impairment
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Severe Renal Impairment
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - End Stage Renal Disease (ESRD)
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
8
|
8
|
7
|
8
|
|
Overall Study
Received At Least One Dose of Study Drug
|
14
|
8
|
8
|
7
|
8
|
|
Overall Study
COMPLETED
|
13
|
8
|
8
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tirzepatide - Control
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection.
|
Tirzepatide - Mild Renal Impairment
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Moderate Renal Impairment
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Severe Renal Impairment
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - End Stage Renal Disease (ESRD)
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function
Baseline characteristics by cohort
| Measure |
Tirzepatide - Control
n=14 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Mild Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Moderate Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Severe Renal Impairment
n=7 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - End Stage Renal Disease (ESRD)
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
52.9 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
60.3 years
STANDARD_DEVIATION 10.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC\[0-tlast\]) of Tirzepatide was evaluated.
Outcome measures
| Measure |
Tirzepatide - Control
n=13 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Mild Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Moderate Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Severe Renal Impairment
n=6 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - End Stage Renal Disease (ESRD)
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast])
|
78400 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 24
|
81900 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 36
|
98300 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 32
|
81200 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 9
|
88500 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 14
|
PRIMARY outcome
Timeframe: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data
Cmax is the maximum observed concentration of Tirzepatide.
Outcome measures
| Measure |
Tirzepatide - Control
n=13 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Mild Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Moderate Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Severe Renal Impairment
n=6 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - End Stage Renal Disease (ESRD)
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
|---|---|---|---|---|---|
|
PK: Maximum Concentration of Tirzepatide
|
339 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 21
|
353 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 42
|
369 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 36
|
417 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 11
|
347 Nanogram per Millilitre (ng/mL)
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\]) of Tirzepatide was evaluated.
Outcome measures
| Measure |
Tirzepatide - Control
n=13 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Mild Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Moderate Renal Impairment
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Severe Renal Impairment
n=6 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - End Stage Renal Disease (ESRD)
n=8 Participants
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf])
|
80500 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 25
|
84200 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 37
|
10400 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 32
|
83000 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 10
|
93400 Nanogram*hour per Millilitre (ng*h/mL)
Geometric Coefficient of Variation 12
|
Adverse Events
Tirzepatide - Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Tirzepatide - Mild Renal Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Tirzepatide - Moderate Renal Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tirzepatide - Severe Renal Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tirzepatide - End Stage Renal Disease (ESRD)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tirzepatide - Control
n=14 participants at risk
Participants received single dose of 5 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Mild Renal Impairment
n=8 participants at risk
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Moderate Renal Impairment
n=8 participants at risk
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - Severe Renal Impairment
n=7 participants at risk
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
Tirzepatide - End Stage Renal Disease (ESRD)
n=8 participants at risk
Participants received single dose of 5mg Tirzepatide by subcutaneous injection.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
14.3%
1/7 • Number of events 1 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
0.00%
0/7 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Up to 28days
|
25.0%
2/8 • Number of events 2 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
0.00%
0/7 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
14.3%
1/7 • Number of events 1 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
0.00%
0/7 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
14.3%
1/7 • Number of events 1 • Up to 28days
|
25.0%
2/8 • Number of events 2 • Up to 28days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
0.00%
0/7 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
12.5%
1/8 • Number of events 1 • Up to 28days
|
0.00%
0/7 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
14.3%
1/7 • Number of events 1 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/14 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
14.3%
1/7 • Number of events 1 • Up to 28days
|
0.00%
0/8 • Up to 28days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60