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

Phase 1

Completed

• Conditions: Healthy; Renal Insufficiency
• Interventions: Drug: LY3437943

• Registration Number: NCT05611957
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Study Start: 2022-11-16
• Primary Completion: 2023-09-05
• Study Completion: 2023-09-05
• Status Verified: 2023-09-15
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3437943 (Control)	LY3437943	LY3437943 administered subcutaneous (SC) to participants with normal renal function
LY3437943 (Severe Renal Impairment)	LY3437943	LY3437943 administered SC to participants with severe renal impairment
LY3437943 (End-Stage Renal Disease)	LY3437943	LY3437943 administered SC to participants with end-stage renal disease

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Orange County Research Center; 🇺🇸 Tustin, California, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Nucleus Networks; 🇺🇸 Saint Paul, Minnesota, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States