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

Completed · Phase 1

Conditions studied: Healthy, Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT05611957

Run by

Eli Lilly and Company

People needed

29

Starts

2022-11-16

Expected to finish

2023-09-05

Last updated by the study team

2023-10-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Orange County Research Center — Tustin, California, 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

Full record on ClinicalTrials.gov

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