A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)

What Was Tested

In this phase 3 trial, researchers set out to test Orforglipron (Foundayo, non-peptide).

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.

More on the Plan

All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria.

All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.

Who Took Part

The registry lists 376 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 completed the SURMOUNT-5 study (NCT05822830; a trial of injectable tirzepatide \[Zepbound\] versus injectable semaglutide \[Wegovy\]) on study treatment.

The full record lists 1 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 a prior or planned surgical treatment for obesity; have acute or chronic hepatitis.

How the Study Was Run

Design: 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.

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 2024-09-13 with completion listed for 2025-11-21.

It ran at 29 sites in United States (27) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment, Change from Baseline in Body Weight and Change from Baseline in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Orforglipron (Foundayo, non-peptide) in 376 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.