NCT05611957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2022

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

November 16, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 15, 2023

Enrollment Period

10 months

First QC Date

November 3, 2022

Last Update Submit

September 29, 2023

Conditions

HealthyRenal Insufficiency

Outcome Measures

Primary Outcomes (2)

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

    PK: AUC0-∞ of LY3437943

    Predose up to 31 days postdose

  • PK: Maximum observed concentration (Cmax) of LY3437943

    PK: Cmax of LY3437943

    Predose up to 31 days postdose

Study Arms (3)

LY3437943 (Control)

EXPERIMENTAL

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

Drug: LY3437943

LY3437943 (Severe Renal Impairment)

EXPERIMENTAL

LY3437943 administered SC to participants with severe renal impairment

Drug: LY3437943

LY3437943 (End-Stage Renal Disease)

EXPERIMENTAL

LY3437943 administered SC to participants with end-stage renal disease

Drug: LY3437943

Interventions

LY3437943DRUG

Administered SC.

LY3437943 (Control)LY3437943 (End-Stage Renal Disease)LY3437943 (Severe Renal Impairment)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orange County Research Center

Tustin, California, 92780, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Nucleus Networks

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

retatrutide

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

November 16, 2022

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

October 2, 2023

Record last verified: 2023-09-15

Data Sharing

IPD Sharing
Will not share

Locations

US(4)