Trial Outcomes & Findings for A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment. (NCT NCT05936138)
NCT ID: NCT05936138
Last Updated: 2026-06-09
Results Overview
PK: (AUC0-∞) of LY3502970 is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
LY3502970 (Normal Renal Function)
A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function \[defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)\] on day 1.
|
LY3502970 (Severe Renal Impairment)
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
LY3502970 (End-Stage Renal Disease)
A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
8
|
|
Overall Study
COMPLETED
|
9
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
LY3502970 (Normal Renal Function)
A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function \[defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)\] on day 1.
|
LY3502970 (Severe Renal Impairment)
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
LY3502970 (End-Stage Renal Disease)
A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
|---|---|---|---|
|
Overall Study
Inadvertent Enrollment
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.
Baseline characteristics by cohort
| Measure |
LY3502970 (Normal Renal Function)
n=10 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with normal renal function \[defined as an eGFR: ≥ 90 mL/min, and without a diagnosis of T2D\] on day 1.
|
LY3502970 (Severe Renal Impairment)
n=6 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
LY3502970 (End-Stage Renal Disease)
n=8 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 6.54 • n=20 Participants
|
61.7 years
STANDARD_DEVIATION 17.07 • n=20 Participants
|
53.8 years
STANDARD_DEVIATION 10.42 • n=40 Participants
|
57.8 years
STANDARD_DEVIATION 11.09 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
20 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
16 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
24 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable PK data.
PK: (AUC0-∞) of LY3502970 is reported.
Outcome measures
| Measure |
LY3502970 (Normal Renal Function)
n=9 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with normal renal function \[defined as an eGFR: ≥ 90 mL/min, and without a diagnosis of T2D\] on day 1.
|
LY3502970 (Severe Renal Impairment)
n=5 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
LY3502970 (End-Stage Renal Disease)
n=7 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970
|
113 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32.1
|
167 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 48.6
|
108 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 87.8
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable PK data.
PK: AUC0-tlast of LY3502970 is reported.
Outcome measures
| Measure |
LY3502970 (Normal Renal Function)
n=9 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with normal renal function \[defined as an eGFR: ≥ 90 mL/min, and without a diagnosis of T2D\] on day 1.
|
LY3502970 (Severe Renal Impairment)
n=5 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
LY3502970 (End-Stage Renal Disease)
n=7 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970
|
98.9 ng*hr/mL
Geometric Coefficient of Variation 32.9
|
120 ng*hr/mL
Geometric Coefficient of Variation 48.9
|
90.2 ng*hr/mL
Geometric Coefficient of Variation 79.7
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdosePopulation: All enrolled participants who received at least one dose of study drug and have evaluable PK data.
PK: Cmax of LY3502970 is reported.
Outcome measures
| Measure |
LY3502970 (Normal Renal Function)
n=9 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with normal renal function \[defined as an eGFR: ≥ 90 mL/min, and without a diagnosis of T2D\] on day 1.
|
LY3502970 (Severe Renal Impairment)
n=5 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
LY3502970 (End-Stage Renal Disease)
n=7 Participants
A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970
|
5.01 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 20.7
|
6.01 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 54.9
|
4.29 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 67.3
|
Adverse Events
LY3502970 (Normal Renal Function)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY3502970 (Severe Renal Impairment)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY3502970 (End-Stage Renal Disease)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY3502970 (Normal Renal Function)
n=10 participants at risk
A single oral dose of 1 mg LY3502970 was administered to participants with normal renal function \[defined as an eGFR: ≥ 90 mL/min, and without a diagnosis of T2D\] on day 1.
|
LY3502970 (Severe Renal Impairment)
n=6 participants at risk
A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
LY3502970 (End-Stage Renal Disease)
n=8 participants at risk
A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/10 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Haemodialysis
|
0.00%
0/10 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline through follow-up (Up to 12 Days)
All enrolled participants who received at least one dose of study drug.
|
62.5%
5/8 • Number of events 20 • Baseline through follow-up (Up to 12 Days)
All enrolled 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: GT60