Phase 1
N=26
A Multiple Dose Study of LY3502970 in Healthy Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05051566 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation — 66.2; 111; 97.4 nanograms per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY3502970 (Drug); Esomeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation |
66.2; 111; 97.4 | — |
| PRIMARY Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation |
988; 1480; 1400 | — |
| PRIMARY Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation |
7.02; 8; 8 | — |
| PRIMARY Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation |
63.4; 56.3; 59.6 | — |
| PRIMARY Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation |
903; 865; 956 | — |
| PRIMARY Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation |
8.00; 7.00; 7.00 | — |
Summary
The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.
Eligibility Criteria
Inclusion Criteria
- Are overtly healthy as determined by medical evaluation.
- Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).
Exclusion Criteria
- Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed
- Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2X ULN (Upper Limit of Normal)
- Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
- Are women of child-bearing potential
- Are women who are lactating
Data sourced from ClinicalTrials.gov (NCT05051566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.