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

Completed · Phase 1

Conditions studied: Renal Insufficiency, Healthy

In brief

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.

Key facts

Study ID

NCT05936138

Run by

Eli Lilly and Company

People needed

24

Starts

2023-07-13

Expected to finish

2024-04-11

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinical Pharmacology of Miami — Miami, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Alliance For multispecialty Research, LLC — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.