NCT07739537Not 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
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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. In longer studies, it has helped people lose weight and improve blood sugar, blood pressure, and cholesterol. By taking part, participants will receive detailed metabolic testing and may receive study results with additional information about their blood sugar and metabolic health.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07739537
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 1 Oct 2026 to the primary completion date, 30 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- Active gallbladder disease or cholecystectomy within the past 6 months
- Psychiatric illness, substance use disorder, or eating disorder that, in the opinion of the investigator, would compromise participant safety or study compliance
Lab values
- 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
- 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
Other
- Current simvastatin dose \>20 mg daily
- Current uses of any oral or injectable GLP-1 receptor agonists, insulin, or the use of two or more antidiabetic agents
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.