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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Insufficiency

Treatments: Drug: LY3437943

Study type: Interventional

Funder types: Industry

Identifiers

NCT05611957

18529

J1I-MC-GZBL (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

LY3437943 (Control)

Experimental group

Description:

LY3437943 administered subcutaneous (SC) to participants with normal renal function

Treatment:

Drug: LY3437943

LY3437943 (Severe Renal Impairment)

Experimental group

Description:

LY3437943 administered SC to participants with severe renal impairment

Treatment:

Drug: LY3437943

LY3437943 (End-Stage Renal Disease)

Experimental group

Description:

LY3437943 administered SC to participants with end-stage renal disease

Treatment:

Drug: LY3437943