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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05611957
Collaborator
(none)
20
Enrollment
2
Locations
3
Arms
5
Anticipated Duration (Months)
10
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Nov 16, 2022
Anticipated Primary Completion Date :
Apr 17, 2023
Anticipated Study Completion Date :
Apr 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3437943 (Control)

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

Drug: LY3437943
Administered SC.
Experimental: LY3437943 (Severe Renal Impairment)

LY3437943 administered SC to participants with severe renal impairment

Drug: LY3437943
Administered SC.
Experimental: LY3437943 (End-Stage Renal Disease)

LY3437943 administered SC to participants with end-stage renal disease

Drug: LY3437943
Administered SC.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. PK: Maximum observed concentration (Cmax) of LY3437943 [Predose up to 31 days postdose]

    PK: Cmax of LY3437943

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Orlando Clinical Research Center Orlando Florida United States 32809
2 Nucleus Networks Saint Paul Minnesota United States 55114

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05611957
Other Study ID Numbers:
  • 18529
  • J1I-MC-GZBL
First Posted:
Nov 10, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency

Study Results

No Results Posted as of Dec 12, 2022