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A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
Plain-language guide to NCT06972472: phase 3 randomized trial of Orforglipron (Foundayo, non-peptide), 600 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06972472
- Phase
- phase 3
- Status
- active, not recruiting
- Start
- 2025-05-19
- Completion (planned or actual)
- 2027-08
- Participants
- 600 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Obesity; Overweight; Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Orforglipron (Foundayo, non-peptide).
This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792).
Participation in the study will last about 18 months.
It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).
Participants will receive orforglipron orally.
Participants will receive orforglipron orally.
Participants will receive orforglipron orally.
The registry classes the interventions as drug.
Who Took Part
The registry lists 600 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening. Have type 2 diabetes. Have a history of at least one unsuccessful dietary effort to lose body weight.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have type 1 diabetes; have an unstable body weight within 90 days prior to screening; have new york heart association functional classification iv congestive heart failure or an acute cardiovascular condition within 90 days prior to screening.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Orforglipron (Foundayo, non-peptide) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Orforglipron (Foundayo, non-peptide) study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2025-05-19 with completion listed for 2027-08.
It ran at 80 sites in United States (35), Japan (13), China (12), Germany (7), Argentina (6) and Czechia (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change from Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 40).
It also tracked 11 secondary outcomes, for example Percent Change from Baseline in Body Weight, Change from Baseline in HbA1c at Week 72, Change from Baseline in Fasting Glucose, Change from Baseline in Waist Circumference, Change from Baseline in Body Mass Index (BMI) and Change from Baseline in Systolic Blood Pressure (SBP).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 600 people.
With 600 participants it is a large trial for this field.
Its status is active not recruiting; 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.