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OpenTrials
Completed

NCT Number: NCT05611957

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

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.

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Key information

Conditions

Healthy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orange County Research Center, Tustin, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3437943

Drug

Administered SC.

Primary outcomes

  1. Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943

    Time frame: Predose up to 31 days postdose

    PK: AUC0-∞ of LY3437943

  2. PK: Maximum observed concentration (Cmax) of LY3437943

    Time frame: Predose up to 31 days postdose

    PK: Cmax of LY3437943

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 10, 2022
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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