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Weight-Loss drugs may cause hidden anal issues, new study warns

NCT ID NCT07668765

Knowledge-focused Sponsor: Gazi University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 100 people with severe obesity who are starting a GLP-1 drug (like Ozempic or Wegovy) to see if it causes new anal or rectal problems within the first 3 months. Participants will have a check-up before starting the drug and again after 3 months to look for issues like hemorrhoids, anal fissures, or changes in bowel habits. The goal is to better understand these side effects so doctors can help patients manage them.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GLP-1 receptor agonist (a class of diabetes/weight-loss drugs)
What this could lead to
If successful, this could help doctors understand and manage common anorectal side effects like constipation or hemorrhoids in people taking GLP-1 drugs for obesity.
What could go wrong
This is a small, early observational study with no control group. It only looks at short-term effects (3 months) and cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

constipation disorder diarrheal disease Drug-Related Side Effects and Adverse Reactions Fissure in Ano hemorrhoid morbid obesity Obesity rectal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anorectal diseases Constipation Diarrhea Drug-related side effects and adverse reactions Morbid obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gazi University Faculty of Medicine

    Ankara, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.