A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

A Parallel-group, Phase 1, Open-label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Renal Impairment Compared With Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05611957

Enrollment

Registered

2022-11-10

Start date

2022-11-16

Completion date

2023-09-05

Last updated

2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Renal Insufficiency

Brief summary

The main purpose of this study is to assess the amount of study drug 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 healthy participants. The study will last up to 5 weeks, excluding screening.

Interventions

DRUGLY3437943

Administered SC.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Normal Participants: * Healthy male and female participants as determined by physical examination * Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min). * Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²) * Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate. Participants with Renal Impairment: * Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator * Participants with type 2 diabetes must have a glycated hemoglobin (HbA1c) ≥ 5.0% and ≤ 11.5% * Are males or females with severe renal impairment as determined by a stable eGFR \<30 mL/min, not requiring hemodialysis OR * Are males or females with end-stage renal disease (have received hemodialysis for at least 3 months)

Exclusion criteria

* Have known allergies to LY3437943 or related compounds * Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed * Have any abnormality in the 12-lead electrocardiogram (ECG) * Are women with a positive pregnancy test or women who are lactating

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943	Predose up to 31 days postdose	PK: AUC0-∞ of LY3437943
PK: Maximum observed concentration (Cmax) of LY3437943	Predose up to 31 days postdose	PK: Cmax of LY3437943

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026