NCT05110794

Brief Summary

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2021

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

October 28, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

June 23, 2022

Status Verified

June 15, 2022

Enrollment Period

3 months

First QC Date

October 28, 2021

Last Update Submit

June 22, 2022

Conditions

Healthy

Keywords

FoodFood Effect

Outcome Measures

Primary Outcomes (3)

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

    PK: Cmax of LY3502970

    Predose up to 41 days postdose

  • PK: Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of LY3502970

    PK: AUC0-24 of LY3502970

    Predose up to 41 days postdose

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

    PK: Tmax of LY3502970

    Predose up to 41 days postdose

Study Arms (2)

LY3502970 (Fed)

EXPERIMENTAL

LY3502970 administered orally to participants who are in a fed state.

Drug: LY3502970

LY3502970 (Fasted)

EXPERIMENTAL

LY3502970 administered orally to participants who are in a fasted state.

Drug: LY3502970

Interventions

LY3502970DRUG

Administered Orally.

LY3502970 (Fasted)LY3502970 (Fed)

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are overtly healthy as determined by medical evaluation.
  • Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

You may not qualify if:

  • Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
  • Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
  • Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.
  • Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.
  • Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Publications (1)

  • Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24.

    PMID: 38402332DERIVED

MeSH Terms

Interventions

orforglipron

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
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 8, 2021

Study Start

November 5, 2021

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

June 23, 2022

Record last verified: 2022-06-15

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)