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A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
Plain-language guide to NCT06440980: phase 1 randomized trial of Orforglipron (Foundayo, non-peptide), 533 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06440980
- Phase
- phase 1
- Status
- completed
- Start
- 2024-06-24
- Completion (planned or actual)
- 2025-06-02
- Participants
- 533 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Healthy; Obese; Overweight; Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Orforglipron (Foundayo, non-peptide).
The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants.
The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated.
The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.
It had 14 arms (groups): Part A: LY3502970 QD Oral Administration (Cohort 1A, Sequence 1) (experimental), Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 2) (experimental), Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 3) (experimental), Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 4) (experimental) and Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 1) (experimental).
The registry classes the interventions as drug.
Who Took Part
533 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: Participants who are overtly healthy as determined by medical history and physical examination. Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. Have venous access sufficient to allow for blood sampling.
The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: have hemoglobin a1c (hba1c) level of 6.5 percent (%) or greater; obesity induced by other endocrine disorders, such as cushing's syndrome or prader-willi syndrome; have undergone bariatric surgery (for example: lap-band, gastric bypass).
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Orforglipron (Foundayo, non-peptide) and who got the comparison, which limits bias.
The Orforglipron (Foundayo, non-peptide) group and the comparison group ran side by side rather than switching.
Being open-label, the Orforglipron (Foundayo, non-peptide) study did not mask who received what.
It started in 2024-06-24 with completion listed for 2025-06-02.
It ran at 7 sites in United States (7).
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Orforglipron (Foundayo, non-peptide) in 533 people.
With 533 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.