NCT06003153 GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
| NCT ID | NCT06003153 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Genetic Predisposition |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 125 participants in total. It began in 2024-03-12 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology.
Eligibility Criteria
Inclusion Criteria: 1. Males or non-pregnant females 2. Ages 18-65 (inclusive) 3. Able/willing to give consent 4. Span the metabolic range between normal glycemia and pre-diabetes (fasting glucose of 100-125 mg/dL based on chart review of existing laboratory data) Exclusion Criteria: 1. Currently taking medications or intending to take medications for diabetes 2. Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones 3. Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis 4. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 5. Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 per the Modification of Diet in Renal Disease equation 6. History of cirrhosis and/or aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal 7. Dietary restrictions preventing consumption of a MMTT 8. Women who are pregnant, nursing, or at risk of becoming pregnant 9. Participation in other interventional studies during the current study
Contact & Investigator
Josephine Li, MD
PRINCIPAL INVESTIGATOR
MGH
Frequently Asked Questions
Who can join the NCT06003153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Genetic Predisposition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06003153 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06003153 currently recruiting?
Yes, NCT06003153 is actively recruiting participants. Contact the research team at vkaur@mgh.harvard.edu for enrollment information.
Where is the NCT06003153 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06003153 clinical trial?
NCT06003153 is sponsored by Massachusetts General Hospital. The principal investigator is Josephine Li, MD at MGH. The trial plans to enroll 125 participants.