A Study of LY3502970 in Participants With Normal and Impaired Renal Function

Healthy Clinical Trial

Official title:

A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05936138
• Other study ID #: 18633
• Secondary ID: J2A-MC-GZPC
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2023
• Est. completion date: April 11, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess the amount of study drug (LY3502970) 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 LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive.

• Men and women who agree to use highly effective or effective methods of contraception may participate in this trial.

Participants with Normal Renal Function:

• Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min)

Participants with Renal Impairment:

• Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis.

• ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.

Exclusion Criteria:

• Have a current, functioning organ transplant. Non-functional renal allografts may be allowed.

• Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications.

• Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy.

• Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study.

• Have a history or presence of chronic or acute pancreatitis

Participants with Renal Impairment:

• Have hemoglobin <8.5 g/dL.

• Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1

Related Conditions & MeSH terms

• Healthy
• Renal Insufficiency

Intervention

Drug:
• LY3502970
Administered orally.

Locations

Country	Name	City	State
United States	Alliance For multispecialty Research, LLC	Knoxville	Tennessee
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-8) of LY3502970	PK: (AUC0-8) of LY3502970	Predose up to 12 days postdose
Primary	PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970	PK: AUC0-tlast of LY3502970	Predose up to 12 days postdose
Primary	PK: Maximum observed concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 12 days postdose