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NCT06003153 · ClinicalTrials.gov registry record · Phase 4
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
A Phase 4 study of Type 2 Diabetes and Genetic Predisposition, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT06003153: Recruiting Phase 4 study of Type 2 Diabetes and Genetic Predisposition, sponsored by Massachusetts General Hospital.
NCT06003153 is a Phase 4 study of Type 2 Diabetes and Genetic Predisposition that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 125 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06003153, a Phase 4 study of Type 2 Diabetes and Genetic Predisposition, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Investigators will measure the change in insulin area under the curve (AUC) over 120 minutes of the MMTT, calculated using the trapezoidal method, between Visit 1 and Visit 2 as an index of response to oral semaglutide, and compare this outcome by genotype at selected loci.
Conditions Studied
Interventions
- DRUG oral semaglutide
- OTHER Mixed Meal Tolerance Test (MMTT)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2024-03-12 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 4 |
What NCT06003153 shows while recruiting
NCT06003153 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which oral semaglutide is the first listed.
NCT06003153 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06003153 about?
NCT06003153 is a clinical study titled "GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH". 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 ...
What is the current status of trial NCT06003153?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 125 participants. The study started on 2024-03-12. Estimated completion is 2027-05-31.
What conditions does trial NCT06003153 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Genetic Predisposition, Metabolic Diseases.
What interventions are being tested in trial NCT06003153?
The interventions under investigation include: oral semaglutide (DRUG), Mixed Meal Tolerance Test (MMTT) (OTHER).
Who is sponsoring clinical trial NCT06003153?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06003153 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06003153's enrollment target sits among peer trials
125 130th of 327 higher than 197 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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