GLP-PROCT

Not yet recruiting

GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity

Early Proctologic Effects of GLP-1 Receptor Agonist Therapy in Morbidly Obese Patients: A Prospective Cohort Study With Baseline and 3-Month Proctologic Assessment

Lead sponsor

Gazi University

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Estimated enrollment

100

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥40

Primary endpoint

•Newly developed proctologic disease

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07668765

Org study IDGU-GLP1-PROCT-2026

Timeline

Milestones

Study first posted2026-06-25actual

Last update posted2026-06-25actual

Study start2026-08estimated (month precision)

Primary completion2027-04estimated (month precision)

Study completion2027-05estimated (month precision)

Assets

Investigational agents

Semaglutide Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Morbidly obese adult patients who are newly prescribed GLP-1 receptor agonist therapy in routine clinical practice and are referred for participation in the study.

Inclusion criteria

•Age ≥18 years

•Morbid obesity (BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities)

•Newly prescribed GLP-1 receptor agonist therapy

•Ability and willingness to provide written informed consent

•Ability to attend 3-month follow-up visit

Exclusion criteria

•Inflammatory bowel disease

•Perianal Crohn's disease

•History of anorectal malignancy

•Previous pelvic radiotherapy

•Anorectal surgery within the previous 3 months

•Pregnancy

•Neurogenic bowel dysfunction

•Inability to comply with follow-up visits

•Discontinuation of GLP-1 receptor agonist therapy before follow-up assessment

•Active anorectal infection or abscess

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Weight & body composition

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Correlation between percent body weight loss and anorectal symptom score

Time frame:3 months

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of participants with worsening of pre-existing anorectal disease

Time frame:3 months

event count, event

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Incidence of newly developed proctologic disease

Time frame:3 months

event count, event

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Change in anorectal symptom severity

Time frame:Baseline to 3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in bowel movement frequency

Time frame:Baseline to 3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Bristol Stool Form Scale score

Time frame:Baseline to 3 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.