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A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants

Plain-language guide to NCT06692348: phase 1 randomized trial of Orforglipron (Foundayo, non-peptide), 86 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06692348
Phase
phase 1
Status
completed
Start
2024-12-13
Completion (planned or actual)
2025-06-09
Participants
86 (actual)
Design
randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1 trial tested Orforglipron (Foundayo, non-peptide).

The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions.

How the body handles and eliminates the study drug after meals and on an empty stomach will be measured.

Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated.

It had 1 arm (groups): Orforglipron (experimental).

The registry classes the interventions as drug.

Who Took Part

86 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Have venous access sufficient to allow for blood sampling. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Orforglipron (Foundayo, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Orforglipron (Foundayo, non-peptide) and the comparison at some point, usually with a gap in between.

Being open-label, the Orforglipron (Foundayo, non-peptide) study did not mask who received what.

It started in 2024-12-13 with completion listed for 2025-06-09.

It ran at 3 sites in Japan (3).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State) (time frame: Week 3 Through Week 16). PK: Steady-state AUC of Orforglipron (Fed State) (time frame: Week 3 Through Week 16). PK: Steady-state Cmax of Orforglipron (Fed State) (time frame: Week 3 Through Week 16).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Orforglipron (Foundayo, non-peptide) in 86 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.

Our Notes on the Compound

Orforglipron (Foundayo, non-peptide): An oral small-molecule GLP-1 receptor agonist (not a peptide); FDA-approved as Foundayo on April 1, 2026 for chronic weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.