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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611957
• Other study ID #: 18529
• Secondary ID: J1I-MC-GZBL
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2022
• Est. completion date: September 5, 2023

Study information

• Verified date: September 15, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Renal Insufficiency

Intervention

Drug:
• LY3437943
Administered SC.

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Nucleus Networks	Saint Paul	Minnesota
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-8) of LY3437943	PK: AUC0-8 of LY3437943	Predose up to 31 days postdose
Primary	PK: Maximum observed concentration (Cmax) of LY3437943	PK: Cmax of LY3437943	Predose up to 31 days postdose