NCT05051566

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2021

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 15, 2022

Enrollment Period

7 months

First QC Date

September 16, 2021

Last Update Submit

April 25, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

    PK: Cmax of LY3502970

    Predose up to 24 hours postdose

  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970

    PK: AUC of LY3502970

    Predose up to 24 hours postdose

  • PK: Time of Maximum Observed Concentration (Tmax) of LY3502970

    PK: Tmax of LY3502970

    Predose up to 24 hours postdose

Study Arms (5)

LY3502970 Prototype (Part A)

EXPERIMENTAL

Multiple doses of LY3502970 prototype administered orally.

Drug: LY3502970

LY3502970 Reference (Part A)

EXPERIMENTAL

Multiple doses of LY3502970 reference administered orally.

Drug: LY3502970

LY3502970 Prototype (Part B)

EXPERIMENTAL

Multiple doses of LY3502970 prototype administered orally.

Drug: LY3502970

LY3502970 Reference (Part B)

EXPERIMENTAL

Multiple doses of LY3502970 reference administered orally.

Drug: LY3502970

Esomeprazole (Part B)

ACTIVE COMPARATOR

Multiple doses of Esomeprazole (Proton Pump Inhibitor) administered orally.

Drug: Esomeprazole

Interventions

LY3502970DRUG

Administered orally.

LY3502970 Prototype (Part A)LY3502970 Prototype (Part B)LY3502970 Reference (Part A)LY3502970 Reference (Part B)
EsomeprazoleDRUG

Administered orally.

Esomeprazole (Part B)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are overtly healthy as determined by medical evaluation.
  • Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical Ltd

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

orforglipronEsomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 21, 2021

Study Start

September 16, 2021

Primary Completion

April 4, 2022

Study Completion

April 4, 2022

Last Updated

April 26, 2022

Record last verified: 2022-04-15

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)