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A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

Plain-language guide to NCT06948422: phase 3 randomized trial of Orforglipron (Foundayo, non-peptide), 974 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06948422
Phase
phase 3
Status
active, not recruiting
Start
2025-04-30
Completion (planned or actual)
2027-09
Participants
974 (estimated)
Design
randomized, double-blind, screening
Conditions studied
Hypertension
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Orforglipron (Foundayo, non-peptide).

The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2).

It had two arms (groups): Orforglipron (GZL1) (experimental) and Orforglipron (GZL2) (experimental).

Participants will receive orforglipron orally or placebo.

Participants will receive orforglipron orally or placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 974 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: Has SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at week 0 (Visit 3). Untreated for hypertension, or on stable antihypertensive medications ≥ 30 days prior to Visit 1. Have a body mass index (BMI) ≥ 25 kg/m².

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: has sbp ≥170 mmhg and/or dbp ≥110 mmhg at visit 1 or at visit 3; has known secondary causes of hypertension; have had any of the following conditions within 90 days prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

The Orforglipron (Foundayo, non-peptide) group and the comparison group ran side by side rather than switching.

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 2025-04-30 with completion listed for 2027-09.

It ran at 100 sites in United States (29), China (12), Argentina (9), Czechia (9), Germany (9) and Poland (8).

Its stated primary purpose is screening.

What Was Measured

Researchers chose this as the main measure: Number of Participants Allocated to Each ISA (time frame: Week -8 to Week 0).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 974 people.

With 974 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.