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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Insufficiency

Treatments: Drug: LY3502970

Study type: Interventional

Funder types: Industry

Identifiers

NCT05936138

18633

J2A-MC-GZPC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

LY3502970 (Control)

Experimental group

Description:

LY3502970 administered orally to participants with normal renal function

Treatment:

Drug: LY3502970

LY3502970 (Severe Renal Impairment)

Experimental group

Description:

LY3502970 administered orally to participants with severe renal impairment

Treatment:

Drug: LY3502970

LY3502970 (End-Stage Renal Disease)

Experimental group

Description:

LY3502970 administered orally to participants with end-stage renal disease (ESRD)

Treatment:

Drug: LY3502970