Clinical trial NCT05611957: A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Renal Insufficiency
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-11-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
timeFrame: Predose up to 31 days postdose
measure: PK: Maximum observed concentration (Cmax) of LY3437943
timeFrame: Predose up to 31 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Saint Paul
country: United States
facility: Nucleus Networks
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: