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
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 StatesSite Not Available
Advanced Pharma Clinical Research
Miami, Florida 33147-4040
United StatesSite Not Available
Clinical Pharmacology of Miami
Miami, Florida 33014
United StatesSite Not Available
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesSite Not Available
Alliance For multispecialty Research, LLC
Knoxville, Tennessee 37920
United StatesSite Not Available
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