Actively Recruiting
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Led by Massachusetts General Hospital · Updated on 2026-04-06
125
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or non-pregnant females
- Ages 18-65 (inclusive)
- Able and willing to give consent
- Fasting glucose between 100-125 mg/dL indicating normal glycemia to pre-diabetes based on existing lab data
You will not qualify if you...
- Currently taking or planning to take medications for diabetes
- Currently taking or planning to take medications that affect glycemic parameters such as glucocorticoids, growth hormone, or fluoroquinolones
- 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
- Estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2
- History of cirrhosis or liver enzymes (AST or ALT) more than three times the upper limit of normal
- Dietary restrictions that prevent consumption of the mixed meal tolerance test
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Participation in other interventional studies during this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
V
Varinderpal Kaur
CONTACT
J
Josephine Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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