Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.

NCTNCT05936138Other id18633Other idJ2A-MC-GZPC

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 24 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 13 Jul 2023
Primary completion: 11 Apr 2024
Completion: 11 Apr 2024
First posted: 7 Jul 2023
Last update posted: 9 Jun 2026
Conditions: Renal Insufficiency · Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 1
A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.
NCT05936138
13 Jul 2023 to 11 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period.

Interventions

LY3502970Drug

Arms3

Experimental
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.
Experimental
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.
Experimental
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.

Primary outcomes3

Outcomes the sponsor listed as primary.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970
Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
Registry description
PK: (AUC0-∞) of LY3502970 is reported.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970
Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
Registry description
PK: AUC0-tlast of LY3502970 is reported.
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
Registry description
PK: Cmax of LY3502970 is reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970

Group	Value (nanogramhour per milliliter (nghr/mL))	Spread
LY3502970 (Normal Renal Function)	113	32.1
LY3502970 (Severe Renal Impairment)	167	48.6
LY3502970 (End-Stage Renal Disease)	108	87.8

Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose

PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970

Group	Value (ng*hr/mL)	Spread
LY3502970 (Normal Renal Function)	98.9	32.9
LY3502970 (Severe Renal Impairment)	120	48.9
LY3502970 (End-Stage Renal Disease)	90.2	79.7

Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose

PK: Maximum Observed Concentration (Cmax) of LY3502970

Group	Value (nanogram per millilitre (ng/mL))	Spread
LY3502970 (Normal Renal Function)	5.01	20.7
LY3502970 (Severe Renal Impairment)	6.01	54.9
LY3502970 (End-Stage Renal Disease)	4.29	67.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LY3502970 (Normal Renal Function)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.	0 / 10	0 / 10	0 / 10
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.	0 / 6	0 / 6	2 / 6
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.	0 / 8	0 / 8	6 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 85 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive. * Men and women who agree to use highly effective or effective methods of contraception may participate in this trial. Participants with Normal Renal Function: * Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min) Participants with Renal Impairment: * Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis. * ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing. Exclusion Criteria: * Have a current, functioning organ transplant. Non-functional renal allografts may be allowed. * Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications. * Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy. * Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study. * Have a history or presence of chronic or acute pancreatitis Participants with Renal Impairment: * Have hemoglobin \<8.5 g/dL. * Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1

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