PATHS-T2D: A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-79
SponsorMassachusetts General Hospital
About this trial
We are conducting a research study to learn 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. In longer studies, it has helped people lose weight and improve blood sugar, blood pressure, and cholesterol. By taking part, you will receive detailed metabolic testing and may receive study results that provide additional information about your blood sugar and metabolic health.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Orforglipron
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov