Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Multiple-Dose Study of LY3502970 in Healthy Participants

NCTNCT05110794Other id18277Other idJ2A-MC-GZGJ

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 34 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
Singapore
Start: 5 Nov 2021
Primary completion: 10 Feb 2022
Completion: 10 Feb 2022
First posted: 8 Nov 2021
Last update posted: 26 May 2026
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 1
A Multiple-Dose Study of LY3502970 in Healthy Participants
NCT05110794
5 Nov 2021 to 10 Feb 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LY3502970Drug

Arms3

Experimental
LY3502970 Titration
Dose Titration Period: Participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21. Day 1 to Day 8: 2 milligram (mg) LY3502970 every day (QD), Day 8 to Day 15: 4 mg LY3502970 QD, Day 15 to Day 21: 8 mg LY3502970 QD, Participants were randomized to Fasted state or Fed state sequence on Day 22.
Experimental
LY3502970 (Fasted/Fed)
Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fasted state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state.
Experimental
LY3502970 (Fed/Fasted)
Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state.

Primary outcomes3

Outcomes the sponsor listed as primary.

PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame · PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
Registry description
PK: Cmax of LY3502970.
PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970
Time frame · PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
Registry description
PK: AUC0-24 of LY3502970.
Time to Maximum Observed Concentration (Tmax) of LY3502970
Time frame · PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
Registry description
PK: Tmax of LY3502970

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

PK: Maximum Observed Concentration (Cmax) of LY3502970

Group	Value (nanograms per milliliter (ng/mL))	Spread
16 mg LY3502970 (Fasted)	80.5	64
16 mg LY3502970 (Fed)	67.5	40

Primary outcomeGeometric mean· PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970

Group	Value (ng*hour(h)/mL)	Spread
16 mg LY3502970 (Fasted)	1200	58
16 mg LY3502970 (Fed)	1050	40

Primary outcomeMedian· PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

Time to Maximum Observed Concentration (Tmax) of LY3502970

Group	Value (hour)
16 mg LY3502970 (Fasted)	8.0
16 mg LY3502970 (Fed)	8.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
2 Milligram (mg) LY3502970 QD2 mg LY3502970 administered orally every day (QD), Day 1 to Day 8.	0 / 33	0 / 33	27 / 33
4 mg LY3502970 QD4 mg LY3502970 administered orally QD, Day 8 to Day 15	0 / 30	0 / 30	15 / 30
8 mg LY3502970 QD8 mg LY3502970 administered orally QD, Day 15 to Day 22.	0 / 30	0 / 30	13 / 30
16 mg LY3502970 QD (Fasted)16 mg LY3502970 administered orally QD (fasted).	0 / 28	0 / 28	18 / 28
16 mg LY3502970 QD (Fed)16 mg LY3502970 administered orally QD (fed).	0 / 27	0 / 27	12 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2024

11 results

Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist.

Ma et al. 2024Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 22

PMID 38402332PMC10951152DOI 10.1007/s13300-024-01554-1PUB-38402332

Free to read · publisher termsCC BY-NC11 results

Read at source See results (11)

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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