RecruitingRecruiting
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
NCT06003153 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
On day 1 (Visit 1), the research subject will present to the Translational and Clinical Research Center (TCRC) after an overnight fast. We will obtain informed consent, check vital signs, take anthropometric measurements, and draw fasting blood work through an intravenous catheter. The subject will then be provided a standard mixed meal to be consumed within 30 minutes. Additional blood will be drawn at the time of meal completion (0 minutes), as well as 5, 15, 30, 60, 90, and 120 minutes following the meal. During study days 3-15, the subject will take 7 mg of oral semaglutide once daily. On day 16 (Visit 2), the research subject will return to the TCRC. During this visit, the subject will take the final (14th) dose of semaglutide, receive fasting blood work, and receive another mixed meal with subsequent blood draws at several time points over 120 minutes.
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
Study design
Enrollment target: 125 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-12
Estimated completion: 2027-05-31
Last updated: 2026-04-06
Interventions
Drug: oral semaglutideOther: Mixed Meal Tolerance Test (MMTT)
Primary outcomes
- • Insulin response to oral semaglutide treatment (15 days)
Sponsor
Massachusetts General Hospital · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactVarinderpal Kaur · contact · vkaur@mgh.harvard.edu · 6176435419
ContactJosephine Li · contact · jli71@mgh.harvard.edu · 617-643-4987
InvestigatorJosephine Li, MD · principal_investigator, MGH
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States