GLP - 1Phase 4NCT07127354
The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality
A Phase 4 study testing Continue GLP/GIP in people with GLP - 1 and Bowel Preparation for Colonoscopy, run by The Cleveland Clinic at 3 sites in United States.
Trial summary
The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are: Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation? Does the quality of bowel preparation differ in patients who… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- GLP - 1, Bowel Preparation for Colonoscopy
- What is being tested?
- Continue GLP/GIP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2025to Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient (Age 18 years or older)
- Patient scheduled for outpatient screening, surveillance, or diagnostic colonoscopy
- Using a GLP-1 or GIP agonist at a stable dose for at least one month
Who cannot join
- Unable to provide informed consent, e.g., dementia
- Patient refuses the USMSTF recommended bowel cleansing regimen for patients with diabetes or obesity (split-dose 4 liters polyethylene glycol + 15 mg bisacodyl the afternoon before; low residue diet 3 days before colonoscopy; clear liquid diet the day before colonoscopy)
- Risk factors for inadequate bowel preparation besides diabetes and obesity with a likelihood ratio of 1.6 or greater:
- Cirrhosis
- Parkinson's disease
- Dementia
Show all 11Show fewer
- Tricyclic antidepressant use
- Opioid use
- Gastroparesis* or suspected gastric outlet obstruction on pre-procedure imaging (*defined based on a documented 4-hour solid phase gastric emptying study or prior history of retained gastric contents during upper endoscopy)
- Previous colorectal surgery
- Prior history of inadequate bowel preparation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Florida, 44195
Samita Garg, M.D., 216-444-7000, GARGS@ccf.org
Samita Garg, M.D.
- Recruiting
Cleveland Clinic
Cleveland, Florida, 44195
Samita Garg, MD, 216-444-2386, GARGS@ccf.org
Samita Garg, MD
- Recruiting
Cleveland Clinic Weston
Weston, Florida, 33331
Tilak Shah, M.D., 877.463.2010, SHAHT3@ccf.org
Akram Ahmad, M.D., ahmada5@ccf.org
About this study
Official title: The Impact of GLP-1 Agonist and GIP Agonist on Bowel Preparation Quality: A Randomized Controlled Trial
The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are:
- Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation?
- Does the quality of bowel preparation differ in patients who hold vs. those who continue a single dose of their GLP-1 or GIP agonist medication?
- Are there any differences in the rates of complications gastric aspiration in patients who hold vs. continue a single dose of their GLP-1 or GIP agonist medication?
- Conditions
- GLP - 1, Bowel Preparation for Colonoscopy
- Being tested
- Continue GLP/GIP
- Keywords
- GLP-1, Bowel preparation for colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continue GLP/GIPDrug
Continue GLP-1 or GIP-based therapy as prescribed prior to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Continue GLP/GIP medication | Active comparator | Patient maintains dose, frequency, duration of medication prior to colonoscopy. Receives: Drug: Continue GLP/GIP |
| Hold medication | No intervention | Withholds prior dose of GLP-1 or GIP therapy per ASA guidance recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of inadequate bowel preparation
Measured: During Surgery
Secondary outcomes (9)
Median Boston bowel prep score
Measured: During Surgery
Median Ottawa bowel preparation score
Measured: During Surgery
Adenoma detection rate
Measured: During Surgery
Colonoscope Insertion time
Time it takes to reach the cecum
Measured: During Surgery
Withdrawal time
Measured: During Surgery
Total procedure time
Measured: During Surgery
Rate of unplanned endotracheal intubation
Measured: During Surgery
hospitalization/emergency department evaluation/readmission for hypoxia or pnemonia within 96 hours after the procedure
Measured: From the day of the procedure to 96 hours after the procedure
Other serious adverse events
Measured: Day of the procedure up to 96 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP - 1Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shah,Tilak, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127354
- Sponsor's protocol ID
- 25-509
- Status last verified
- Nov 2025
- First submitted
- 11 Aug 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of GLP-1 Agonist and GIP Agonist on Bowel Preparation Quality: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07127354
- Acronym / sponsor ID
- 25-509
- Conditions
- GLP - 1, Bowel Preparation for Colonoscopy
- Keywords
- GLP-1, Bowel preparation for colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are:
- Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation?
- Does the quality of bowel preparation differ in patients who hold vs. those who continue a single dose of their GLP-1 or GIP agonist medication?
- Are there any differences in the rates of complications gastric aspiration in patients who hold vs. continue a single dose of their GLP-1 or GIP agonist medication?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue GLP/GIP medication | Active comparator | Drug: Continue GLP/GIPPatient maintains dose, frequency, duration of medication prior to colonoscopy. |
| Hold medication | No intervention | –Withholds prior dose of GLP-1 or GIP therapy per ASA guidance recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (Age 18 years or older)
- Patient scheduled for outpatient screening, surveillance, or diagnostic colonoscopy
- Using a GLP-1 or GIP agonist at a stable dose for at least one month
Key exclusion criteria (11 listed)
- Unable to provide informed consent, e.g., dementia
- Patient refuses the USMSTF recommended bowel cleansing regimen for patients with diabetes or obesity (split-dose 4 liters polyethylene glycol + 15 mg bisacodyl the afternoon before; low residue diet 3 days before colonoscopy; clear liquid diet the day before colonoscopy)
- Risk factors for inadequate bowel preparation besides diabetes and obesity with a likelihood ratio of 1.6 or greater:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continue GLP/GIPContinue GLP-1 or GIP-based therapy as prescribed prior to the procedure. | Drug | Continue GLP/GIP medication |
Primary outcome
Rate of inadequate bowel preparation
Time frame: During Surgery
9 secondary outcomes
Median Boston bowel prep score
Time frame: During Surgery
Median Ottawa bowel preparation score
Time frame: During Surgery
Adenoma detection rate
Time frame: During Surgery
Colonoscope Insertion time
Time frame: During Surgery
Withdrawal time
Time frame: During Surgery
Total procedure time
Time frame: During Surgery
Rate of unplanned endotracheal intubation
Time frame: During Surgery
hospitalization/emergency department evaluation/readmission for hypoxia or pnemonia within 96 hours after the procedure
Time frame: From the day of the procedure to 96 hours after the procedure
Other serious adverse events
Time frame: Day of the procedure up to 96 hours after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continue GLP/GIP in people with GLP - 1 and Bowel Preparation for Colonoscopy, run by The Cleveland Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of inadequate bowel preparation (time frame: During Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.