A Multiple-Dose Study of LY3502970 in Healthy Participants

NCT ID: NCT05110794

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2022-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3502970 (Fed)

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

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered Orally.

LY3502970 (Fasted)

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

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered Orally.

Interventions

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LY3502970

Administered Orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type DERIVED
PMID: 38402332 (View on PubMed)

Other Identifiers

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J2A-MC-GZGJ

Identifier Type: OTHER

Identifier Source: secondary_id

18277

Identifier Type: -

Identifier Source: org_study_id

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