PATHS-T2D

Not yet recruitingPhase 4

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

Polygenic Assessment and Testing of Heterogeneity and Subtypes in Type 2 Diabetes (PATHS-T2D): A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses

Lead sponsor

Massachusetts General Hospital

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

100

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoints

•Physiologic characterization by MMTT•Acute drug challenges

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07739537

Org study ID2026P002001

Secondary ID1R01DK148455-01

Timeline

Milestones

Study first posted2026-07-31actual

Last update posted2026-08-31actual

Study start2026-10-01estimated

Primary completion2029-09-30estimated

Study completion2030-09-30estimated

Assets

Investigational agents

Orforglipron

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age79 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•Known contraindication for orforglipron (e.g., Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN 2), allergies to any component)

•Personal history of pancreatitis, gallbladder disease, intestinal malabsorption, severe gastroparesis, gastric outlet obstruction, or other clinically significant gastrointestinal motility disorder

•History of liver disease or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x upper limit of normal

•Estimated glomerular filtration rate (eGFR) < 45 mg/min/1.73m2 per the Modification of Diet in Renal Disease equation

•Active gallbladder disease or cholecystectomy within the past 6 months

•Current use of a strong CYP3A4 inducer (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, rifabutin, or St. John's wort) or ritonavir, cobicistat, cyclosporine, or another strong CYP3A4 inhibitor that also inhibits OATP1B

•Current simvastatin dose >20 mg daily

•Measured most recent HbA1c level greater than 7.5% in the last 6 months

•Average glucose by fingerstick or continuous glucose monitor exceeding 180 mg/dL in the last 3 months

•Current uses of any oral or injectable GLP-1 receptor agonists, insulin, or the use of two or more antidiabetic agents

•Currently taking or planning to start other medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones during the study

•Planned to change any prescribed medication during the study

•Planned surgeries or procedures requiring general anesthesia during or within 10 days after completing the study

•Participating in any other interventional study simultaneously

•Dietary restrictions that prevent the consumption of the standardized liquid mixed meal

•Pregnant, nursing, or postpartum in the last 6 months

•Current suicidal ideation or suicide attempt within the past 5 years

•Psychiatric illness, substance use disorder, or eating disorder that, in the opinion of the investigator, would compromise participant safety or study compliance

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Physiologic characterization by MMTT

Time frame:1 day

descriptive

Primary/protocol endpoint/low confidence

The acute drug challenges

Time frame:12 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.