NCT06003153RecruitingPhase 4
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- First submitted
- 9 Aug 2023
- Start date
- 12 Mar 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06003153
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 125
- From 12 Mar 2024 to the primary completion date, 31 May 2027
- 1 site in 1 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
- Currently taking medications or intending to take medications for diabetes
- Currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
Other illness
- Personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
- History of cirrhosis and/or aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal
Lab values
- Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 per the Modification of Diet in Renal Disease equation
Other
- Dietary restrictions preventing consumption of a MMTT
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Participation in other interventional studies during the current study
Who the study is looking for
- Males or non-pregnant females
- Ages 18-65 (inclusive)
- Able/willing to give consent
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.