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

Last updated: April 22, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

1

Condition

Kidney Disease

Kidney Failure (Pediatric)

Renal Failure

Treatment

LY3502970

Clinical Study ID

NCT05936138
18633
J2A-MC-GZPC
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 contraceptionmay participate in this trial. Participants with Normal Renal Function:
  • Healthy males or females as determined by medical history, physical examination, andother screening procedures, with normal renal function. Have estimated glomerularfiltration 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 3months prior to planned dosing.

Exclusion

Exclusion Criteria:

  • Have a current, functioning organ transplant. Non-functional renal allografts may beallowed.
  • Regularly use known drugs of abuse or show positive findings on urinary drug screenthat are not otherwise explained by permitted concomitant medications.
  • Have known allergies to LY3502970, related compounds, or any components of theformulation, or history of severe atopy.
  • Are lactating, pregnant, or intend to become pregnant, or to breastfeed during thestudy.
  • 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-likePeptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor inthe past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosingon Day 1

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: LY3502970
Phase: 1
Study Start date:
July 13, 2023
Estimated Completion Date:
April 11, 2024

Connect with a study center

  • Advanced Pharma CR, LLC

    Miami, Florida 33147
    United States

    Site Not Available

  • Advanced Pharma Clinical Research

    Miami, Florida 33147-4040
    United States

    Site Not Available

  • Clinical Pharmacology of Miami

    Miami, Florida 33014
    United States

    Site Not Available

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Site Not Available

  • Alliance For multispecialty Research, LLC

    Knoxville, Tennessee 37920
    United States

    Site Not Available

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