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

NCT05936138 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18633J2A-MC-GZPC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

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.

Conditions

Renal Insufficiency; Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970

  PK: (AUC0-∞) of LY3502970

  Predose up to 12 days postdose

• PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970

  PK: AUC0-tlast of LY3502970

  Predose up to 12 days postdose

• PK: Maximum observed concentration (Cmax) of LY3502970

  PK: Cmax of LY3502970

  Predose up to 12 days postdose

Study Arms (3)

LY3502970 (Control)

EXPERIMENTAL

LY3502970 administered orally to participants with normal renal function

Drug: LY3502970

LY3502970 (Severe Renal Impairment)

EXPERIMENTAL

LY3502970 administered orally to participants with severe renal impairment

Drug: LY3502970

LY3502970 (End-Stage Renal Disease)

EXPERIMENTAL

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

Drug: LY3502970

Interventions

LY3502970 DRUG

Administered orally.

LY3502970 (Control); LY3502970 (End-Stage Renal Disease); LY3502970 (Severe Renal Impairment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Alliance For multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 7, 2023
• Study Start: July 13, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)