Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1 Therapy Discontinuation

What Was Tested

This registered phase 4 trial tested Orforglipron (Foundayo, non-peptide).

This study will compare the effect of orforglipron and phentermine on weight maintenance.

It had two arms (groups): Phentermine (active comparator) and Orforglipron (active comparator).

Phentermine.

Orforglipron.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-80 years at screening. History of BMI ≥30 kg/m². Current or recent (within 8 weeks) treatment with injectable semaglutide, tirzepatide, or similar GLP-1 based medication. Willing to participate in the study after reviewing study infographic and confirming understanding of randomization and study procedures. Ability to understand and the willingness to sign a written informed consent document.

The full record lists 7 inclusion and 25 exclusion criteria; among the exclusions: current type 2 diabetes mellitus; recent or planned surgical obesity treatment (bariatric surgery \>1 year prior to glp-1 initiation allowed); pregnancy, intent to become pregnant, or current breastfeeding (participants of childbearing potential must have a negative pregnancy test at baseline).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Being open-label, the Orforglipron (Foundayo, non-peptide) study did not mask who received what.

It started in 2026-11-01 with completion listed for 2031-07-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent change in body weight (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Orforglipron (Foundayo, non-peptide) in 60 people.

Its status is not yet 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.