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A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight

Plain-language guide to NCT06824051: phase 1 randomized trial of Orforglipron (Foundayo, non-peptide), 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06824051
Phase
phase 1
Status
completed
Start
2025-02-17
Completion (planned or actual)
2026-01-26
Participants
120 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Obesity; Overweight
Results posted
not yet

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 orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight.

Participation in the study will last approximately 8 months.

It had two arms (groups): Orforglipron (experimental) and Placebo (placebo comparator).

Participants will receive orforglipron orally.

Participants will receive placebo orally.

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 actual participants took part.

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 a Body Mass Index (BMI). ≥30.0 kilograms per square meter (kg/m2), or. ≥27.0 kg/m2 with comorbidities.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma; have an unstable body weight within 90 days prior to screening; have acute or chronic hepatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Orforglipron (Foundayo, non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2025-02-17 with completion listed for 2026-01-26.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline in Visceral Adipose Tissue (VAT) (time frame: Baseline, Week 36).

It also tracked 6 secondary outcomes, for example Percent Change from Baseline in Energy Intake, Percent Change from Baseline in Appetite, Percent Change from Baseline in Body Weight, Percent Change from Baseline in Fasting Total Cholesterol, Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) and Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Orforglipron (Foundayo, non-peptide) in 120 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.