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CompletedNCT05611957Updated Oct 2, 2023

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

A Phase 1 interventional study of LY3437943 in Healthy and Renal Insufficiency, sponsored by Eli Lilly and Company. Completed at 4 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-02.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Sep 2023, 3 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Renal Insufficiency

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 29 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    LY3437943 (Control)

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

    Drug: LY3437943

  • Experimental
    LY3437943 (Severe Renal Impairment)

    LY3437943 administered SC to participants with severe renal impairment

    Drug: LY3437943

  • Experimental
    LY3437943 (End-Stage Renal Disease)

    LY3437943 administered SC to participants with end-stage renal disease

    Drug: LY3437943

Interventions

  • DrugLY3437943

    Administered SC.

06

What researchers measure

Primary outcomes

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

    PK: AUC0-∞ of LY3437943

    Time frame: Predose up to 31 days postdose

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

    PK: Cmax of LY3437943

    Time frame: Predose up to 31 days postdose

07

Study locations

4 sites
  • Orange County Research Center
    Tustin, California 92780, United States
  • Clinical Pharmacology of Miami
    Miami, Florida 33014-3616, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • Nucleus Networks
    Saint Paul, Minnesota 55114, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05611957
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 10, 2022
Start date
Nov 16, 2022
Primary completion
Sep 5, 2023
Completion
Sep 5, 2023
Last update
Oct 2, 2023

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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