Clinical trial NCT05936138: A Study of LY3502970 in Participants With Normal and Impaired Renal Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970
timeFrame: Predose up to 12 days postdose
measure: PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970
timeFrame: Predose up to 12 days postdose
measure: PK: Maximum observed concentration (Cmax) of LY3502970
timeFrame: Predose up to 12 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Knoxville
country: United States
facility: Alliance For multispecialty Research, LLC
state: Tennessee
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: