CompletedNCT05051566Updated May 29, 2026Results posted

A Multiple Dose Study of LY3502970 in Healthy Participants

A Phase 1 interventional study of LY3502970 and Esomeprazole in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 26
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 26 participants (actual)

Study arms

Experimental
Part A
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 milligrams (mg), increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD) * Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
Drug: LY3502970
Experimental
Part B
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI 40 mg Esomeprazole tablet first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK (pharmacokinetic) parameters were evaluated under these elevated gastric pH conditions
Drug: LY3502970 · Drug: Esomeprazole

Interventions

DrugLY3502970
Administered orally.
DrugEsomeprazole
Administered orally.

What researchers measure

Primary outcomes

Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
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
Part A: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Part A: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Part B: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
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
Part B: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Part B: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

Results

Posted May 29, 2026

Participant flow

The study was conducted in 2 parts: Part A: This is the initial formulation evaluation phase, where multiple oral doses of LY3502970 formulation prototypes were tested in a group of participants. Part B: This is the secondary evaluation phase in another group of participants, where, depending on the results of Part A, one of the prototypes may be further evaluated with regard to the effects of food, proton pump inhibitors (PPIs), or additional prototype formulations may be explored.

Participant flow — Overall Study
Milestone	Part A	Part B
Started	12	14
Received at least 1 dose of study drug (safety analyses set)	12	14
Completed	10	12
Not completed	2	2
Withdrew: Withdrawal by subject	2	0
Withdrew: Adverse event	0	2

Outcome measures

PrimaryPart A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

Time frame:: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Reported as:: Geometric mean · nanograms per milliliter (ng/mL)

Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
nanograms per milliliter (ng/mL)	Part A (LY3502970)
16 mg reference capsule (Day 24)	66.2 ± 77.4
16 mg prototype 1 tablet (Days 30 and 36)	111 ± 81.2
16 mg prototype 2 tablet (Days 30 and 36)	97.4 ± 58.9

PrimaryPart 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

Part A: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

Time frame:: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Reported as:: Geometric mean · nanogram*hours per milliliter (ng*h/mL)

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
nanogramhours per milliliter (ngh/mL)	Part A (LY3502970)
16 mg reference capsule (Day 24)	988 ± 66.9
16 mg prototype 1 tablet (Days 30 and 36)	1480 ± 75.2
16 mg prototype 2 tablet (Days 30 and 36)	1400 ± 51.2

PrimaryPart A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Part A: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).

Time frame:: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Reported as:: Median · hours

Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
hours	Part A (LY3502970)
16 mg reference capsule (Day 24)	7.02 (4 to 8)
16 mg prototype 1 tablet (Days 30 and 36)	8 (4 to 16)
16 mg prototype 2 tablet (Days 30 and 36)	8 (4 to 16)

PrimaryPart B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Part B: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

Time frame:: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Reported as:: Geometric mean · ng/mL

Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
ng/mL	Part B
16 mg prototype 2 tablet (Fasted) (Day 24)	63.4 ± 32.2
16 mg prototype 2 tablet (Fed) (Day 30)	56.3 ± 29.6
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)	59.6 ± 51.0

PrimaryPart 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

Part B: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

Time frame:: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Reported as:: Geometric mean · ng*h/mL

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
ng*h/mL	Part B
16 mg prototype 2 tablet (Fasted) (Day 24)	903 ± 25.3
16 mg prototype 2 tablet (Fed) (Day 30)	865 ± 24.6
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)	956 ± 40.1

PrimaryPart B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Part B: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.

Time frame:: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Reported as:: Median · hours

Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
hours	Part B
16 mg prototype 2 tablet (Fasted) (Day 24)	8.00 (4.00 to 12.00)
16 mg prototype 2 tablet (Fed) (Day 30)	7.00 (2.00 to 16.05)
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)	7.00 (4.00 to 12.00)

Adverse events

Collected over Baseline to the end of follow-up (up to Day 53). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part A - 2 mg Capsule	0/12 (0%)	0/12 (0%)	11/12 (91.7%)
Part A - 4 mg Capsule	0/12 (0%)	0/12 (0%)	11/12 (91.7%)
Part A - 8 mg Capsule	0/12 (0%)	0/12 (0%)	11/12 (91.7%)
Part A - 16 mg Capsule	0/11 (0%)	0/11 (0%)	11/11 (100%)
Part A - 16 mg Prototype 1 Tablet	0/10 (0%)	0/10 (0%)	9/10 (90%)
Part A - 16 mg Prototype 2 Tablet	0/10 (0%)	0/10 (0%)	8/10 (80%)
Part B - 2 mg Capsule	0/14 (0%)	0/14 (0%)	13/14 (92.9%)
Part B - 4 mg Capsule	0/14 (0%)	0/14 (0%)	12/14 (85.7%)
Part B - 8 mg Capsule	0/14 (0%)	0/14 (0%)	13/14 (92.9%)
Part B -16 mg Prototype 2 Tablet/Fasted	0/14 (0%)	0/14 (0%)	12/14 (85.7%)
Part B - 16 mg Prototype 2 Tablet/Fed	0/12 (0%)	0/12 (0%)	8/12 (66.7%)
Part B - 16 mg Prototype 2 Tablet + PPI	0/12 (0%)	0/12 (0%)	8/12 (66.7%)

Most frequent other events

Showing 10 of 69

Most frequent other events
Event	Part A - 2 mg Capsule	Part A - 4 mg Capsule	Part A - 8 mg Capsule	Part A - 16 mg Capsule	Part A - 16 mg Prototype 1 Tablet	Part A - 16 mg Prototype 2 Tablet	Part B - 2 mg Capsule	Part B - 4 mg Capsule	Part B - 8 mg Capsule	Part B -16 mg Prototype 2 Tablet/Fasted	Part B - 16 mg Prototype 2 Tablet/Fed	Part B - 16 mg Prototype 2 Tablet + PPI
NauseaGastrointestinal disorders	7/12	6/12	6/12	8/11	5/10	6/10	7/14	3/14	3/14	4/14	3/12	1/12
Weight decreasedInvestigations	0/12	0/12	8/12	0/11	0/10	0/10	0/14	0/14	3/14	3/14	1/12	1/12
ConstipationGastrointestinal disorders	5/12	1/12	4/12	3/11	0/10	0/10	7/14	3/14	3/14	1/14	1/12	1/12
HeadacheNervous system disorders	6/12	3/12	4/12	2/11	3/10	0/10	4/14	2/14	0/14	4/14	1/12	1/12
Decreased appetiteMetabolism and nutrition disorders	5/12	2/12	3/12	0/11	0/10	0/10	6/14	2/14	2/14	0/14	1/12	0/12
Abdominal distensionGastrointestinal disorders	4/12	1/12	1/12	1/11	2/10	1/10	4/14	1/14	0/14	0/14	1/12	1/12
VomitingGastrointestinal disorders	4/12	0/12	1/12	2/11	1/10	1/10	4/14	0/14	0/14	2/14	1/12	0/12
FatigueGeneral disorders	1/12	0/12	0/12	0/11	3/10	0/10	1/14	0/14	0/14	0/14	0/12	0/12
DysgeusiaNervous system disorders	0/12	0/12	2/12	1/11	3/10	0/10	1/14	0/14	0/14	0/14	0/12	0/12
Abdominal discomfortGastrointestinal disorders	0/12	1/12	2/12	2/11	0/10	0/10	0/14	0/14	3/14	3/14	1/12	0/12

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Categorical
Age, Categorical(Participants)	Part A (LY3502970)	Part B (LY3502970)	Total
<=18 years	0	0	0
Between 18 and 65 years	12	14	26
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Part A (LY3502970)	Part B (LY3502970)	Total
Female	3	1	4
Male	9	13	22

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part A (LY3502970)	Part B (LY3502970)	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	12	14	26
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part A (LY3502970)	Part B (LY3502970)	Total
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	11	14	25
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Study locations

1 site

Quotient Clinical Ltd
Nottingham, NG11 6JS, United Kingdom

References and documents

Study documents

Study protocol · Jan 31, 2022
Statistical analysis plan · Oct 5, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05051566
Lead sponsor: Eli Lilly and Company
Collaborators: Quotient Sciences
Responsible party: Sponsor
First posted: Sep 21, 2021
Start date: Sep 16, 2021
Primary completion: Apr 4, 2022
Completion: Apr 4, 2022
Results posted: May 29, 2026
Last update: May 29, 2026

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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