PATHS-T2D: A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses

What Was Tested

In this phase 4 trial, researchers set out to test Orforglipron (Foundayo, non-peptide).

This research study aims to learn about how the body responds to food through different genetic pathways and how these responses may change during a short course of orforglipron.

Orforglipron is an oral glucagon-like peptide-1 (GLP-1) receptor agonist that was approved by the U.S.

Food and Drug Administration (FDA) on April 1, 2026, for long-term weight management.

It had two arms (groups): Drug challenge (experimental) and Baseline (no intervention).

MMTT pre-drug challenge.

The registry classes the interventions as drug.

More on the Plan

This study will enroll approximately 100 adults aged 18-79 years who have previously agreed to be recontacted for future studies through the MGB biobank.

The study population will consist of four groups of high genetic risk for glycemic/insulinemic associations based on three pPS, along with controls selected from the interquartile range (IQR) across all pPS to provide a mechanism-agnostic comparator.

Blood glucose, insulin, and incretin hormone levels will be measured during a baseline mixed-meal tolerance test (MMTT) at Visit 1.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 79 years.

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

Examples of who could join: Adult male or non-pregnant female volunteers (Age 18-79). Not currently taking more than two home oral antidiabetic agents, with or without a diagnosis of type 2 diabetes. Able and willing to stop home oral antidiabetic medications for 5 days prior to the start of the study, with approval from healthcare providers. Able and willing to give informed consent.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: history of liver disease or aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>3 x upper limit of normal; active gallbladder disease or cholecystectomy within the past 6 months; current uses of any oral or injectable glp-1 receptor agonists, insulin, or the use of two or more antidiabetic agents.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-10-01 with completion listed for 2029-09-30.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Physiologic characterization by MMTT (time frame: 1 day). The acute drug challenges (time frame: 12 days).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Orforglipron (Foundayo, non-peptide) in 100 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.