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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05936138
Collaborator
(none)
26
Enrollment
4
Locations
3
Arms
11.3
Anticipated Duration (Months)
6.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Jul 13, 2023
Anticipated Primary Completion Date :
Jun 21, 2024
Anticipated Study Completion Date :
Jun 21, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3502970 (Control)

LY3819469 administered orally to participants with normal renal function

Drug: LY3502970
Administered orally.
Experimental: LY3502970 (Severe Renal Impairment)

LY3502970 administered orally to participants with severe renal impairment

Drug: LY3502970
Administered orally.
Experimental: LY3502970 (End-Stage Renal Disease)

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

Drug: LY3502970
Administered orally.

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970 [Predose up to 12 days postdose]

    PK: (AUC0-∞) of LY3502970

  2. PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970 [Predose up to 12 days postdose]

    PK: AUC0-tlast of LY3502970

  3. PK: Maximum observed concentration (Cmax) of LY3502970 [Predose up to 12 days postdose]

    PK: Cmax of LY3502970

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Pharmacology of Miami Miami Florida United States 33014
2 Advanced Pharma Clinical Research Miami Florida United States 33147-4040
3 Orlando Clinical Research Center Orlando Florida United States 32809
4 Alliance for Multispecialty Research, LLC Knoxville Tennessee United States 37920

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05936138
Other Study ID Numbers:
  • 18633
  • J2A-MC-GZPC
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 30, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency

Study Results

No Results Posted as of Jul 7, 2023