Trial Outcomes & Findings for A Study of LY3502970 in Participants With Impaired and Normal Liver Function (NCT NCT05882032)
NCT ID: NCT05882032
Last Updated: 2026-05-27
Results Overview
PK: AUC (0-∞) of LY3502970.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Results posted on
2026-05-27
Participant Flow
Participant milestones
| Measure |
1 mg LY3502970 (Control: Normal Hepatic Function)
Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Mild Hepatic Impairment)
Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Moderate Hepatic Impairment)
Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Severe Hepatic Impairment)
Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
6
|
6
|
|
Overall Study
Received At Least One Dose of LY3502970
|
11
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
Baseline characteristics by cohort
| Measure |
1 mg LY3502970 (Control: Normal Hepatic Function)
n=11 Participants
Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Mild Hepatic Impairment)
n=6 Participants
Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Moderate Hepatic Impairment)
n=6 Participants
Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Severe Hepatic Impairment)
n=6 Participants
Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 11.2 • n=51 Participants
|
58.8 years
STANDARD_DEVIATION 14.6 • n=14 Participants
|
64.3 years
STANDARD_DEVIATION 5.5 • n=65 Participants
|
47.5 years
STANDARD_DEVIATION 6.8 • n=24 Participants
|
55.8 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
4 Participants
n=24 Participants
|
12 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
5 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
17 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
4 Participants
n=24 Participants
|
18 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
11 Participants
n=107 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=107 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
6 Participants
n=65 Participants
|
6 Participants
n=24 Participants
|
25 Participants
n=107 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
6 Participants
n=65 Participants
|
6 Participants
n=24 Participants
|
29 Participants
n=107 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1Population: All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).
PK: AUC (0-∞) of LY3502970.
Outcome measures
| Measure |
1 mg LY3502970 (Moderate Hepatic Impairment)
n=6 Participants
Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Severe Hepatic Impairment)
n=6 Participants
Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Control: Normal Hepatic Function)
n=10 Participants
Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Mild Hepatic Impairment)
n=6 Participants
Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970
|
209 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 32.6
|
611 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 84.6
|
130 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26.8
|
132 nanogram *hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 60.2
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1Population: All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).
PK: AUC0-tlast of LY3502970.
Outcome measures
| Measure |
1 mg LY3502970 (Moderate Hepatic Impairment)
n=6 Participants
Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Severe Hepatic Impairment)
n=6 Participants
Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Control: Normal Hepatic Function)
n=10 Participants
Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Mild Hepatic Impairment)
n=6 Participants
Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970
|
169 ng*h/mL
Geometric Coefficient of Variation 32.7
|
385 ng*h/mL
Geometric Coefficient of Variation 54.7
|
109 ng*h/mL
Geometric Coefficient of Variation 29.1
|
112 ng*h/mL
Geometric Coefficient of Variation 64.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1Population: All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).
PK: Cmax of LY3502970.
Outcome measures
| Measure |
1 mg LY3502970 (Moderate Hepatic Impairment)
n=6 Participants
Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Severe Hepatic Impairment)
n=6 Participants
Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Control: Normal Hepatic Function)
n=11 Participants
Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Mild Hepatic Impairment)
n=6 Participants
Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
|---|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970
|
6.12 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43.6
|
5.95 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36.1
|
5.10 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21.0
|
5.47 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 57.5
|
Adverse Events
1 mg LY3502970 (Control: Normal Hepatic Function)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1 mg LY3502970 (Mild Hepatic Impairment)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1 mg LY3502970 (Moderate Hepatic Impairment)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1 mg LY3502970 (Severe Hepatic Impairment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 mg LY3502970 (Control: Normal Hepatic Function)
n=11 participants at risk
Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Mild Hepatic Impairment)
n=6 participants at risk
Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Moderate Hepatic Impairment)
n=6 participants at risk
Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
1 mg LY3502970 (Severe Hepatic Impairment)
n=6 participants at risk
Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11 • Number of events 1 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
16.7%
1/6 • Number of events 1 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
16.7%
1/6 • Number of events 1 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
0.00%
0/6 • Baseline up to end of follow-up (up to 14 days)
Safety population consisted of all enrolled participants who received at least one dose of LY3502970.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60