A Study of LY3473329 in Participants With Impaired and Normal Renal Function

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05778864
• Collaborator: (none)
• Enrollment: 48
• Locations: 4
• Arms: 5
• Anticipated Duration (Months): 8.6
• Patients Per Site: 12
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the amount of study drug (LY3473329) 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 participants with normal renal function. The safety and tolerability of LY3473329 will also be evaluated in these participants. The study will last up to 8 weeks including screening period.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency	Drug: LY3473329	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics of LY3473329 Following Oral Administration in Participants With Renal Impairment Compared With Participants With Normal Renal Function
• Anticipated Study Start Date: Mar 16, 2023
• Anticipated Primary Completion Date: Dec 4, 2023
• Anticipated Study Completion Date: Dec 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3473329 (Control) LY3473329 administered orally to participants with normal renal function	Drug: LY3473329; Administered orally.
Experimental: LY3473329 (Mild Renal Impairment) LY3473329 administered orally to participants with mild renal impairment	Drug: LY3473329; Administered orally.
Experimental: LY3473329 (Moderate Renal Impairment) LY3473329 administered orally to participants with moderate renal impairment	Drug: LY3473329; Administered orally.
Experimental: LY3473329 (Severe Renal Impairment) LY3473329 administered orally to participants with severe renal impairment	Drug: LY3473329; Administered orally.
Experimental: LY3473329 (End-Stage Renal Disease) LY3473329 administered orally to participants with end-stage renal disease	Drug: LY3473329; Administered orally.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329 [Predose up to 34 days postdose]

   PK: AUC0-∞ of LY3473329

2. PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329 [Predose up to 34 days postdose]

   PK: AUC0-tlast of LY3473329

3. PK: Maximum observed concentration (Cmax) of LY3473329 [Predose up to 34 days postdose]

   PK: Cmax of LY3473329

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)

• Men who agree to use highly effective or effective methods of contraception, women of childbearing potential (WOCP) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (WNOCBP) may participate in this trial

• Have clinical laboratory test results within the normal reference range for the population

Exclusion Criteria:

• Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study

• Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study

• Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms

• Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age

• Smoke more than 10 cigarettes per day or the equivalent

• Have donated blood of more than 500 milliliter (mL) within 3 months prior to screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida	United States	32132
2	Advanced Pharma Clinical Research	Miami	Florida	United States	33147-4040
3	Orlando Clinical Research Center	Orlando	Florida	United States	32809
4	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee	United States	37920

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: NCT05778864
• Other Study ID Numbers: 18638; J2O-MC-EKBE
• First Posted: Mar 21, 2023
• Last Update Posted: Mar 21, 2023
• Last Verified: Mar 7, 2023

• 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 Mar 21, 2023