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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2024-04-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Insufficiency Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3502970 (Control)

LY3502970 administered orally to participants with normal renal function

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

LY3502970 (Severe Renal Impairment)

LY3502970 administered orally to participants with severe renal impairment

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

LY3502970 (End-Stage Renal Disease)

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

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Interventions

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LY3502970

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes