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Nerve damage may worsen semaglutide side effect, study warns

NCT ID NCT07156591

Knowledge-focused Sponsor: Fudan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study will follow 460 diabetes patients who take semaglutide to see if those with nerve damage (neuropathy) are more likely to develop stomach retention, where food stays in the stomach too long. Participants will have a stomach exam to check for retained food or liquid. The goal is to better understand who might be at risk for this side effect.

What this could mean

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

Active substance
semaglutide
What this could lead to
If it works, this could help doctors identify which patients on semaglutide are at higher risk for stomach retention, leading to safer prescribing.
What could go wrong
This is an observational study, not a treatment trial. It only looks for a link, not a cause, and results may not apply to all patients.

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 460 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

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

Diabetic patients undergoing esophagogastroduodenoscopy who have been on long-term semaglutide therapy (≥4 weeks), either with neuropathy (exposure group) or without neuropathy (non-exposure group).

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: * Confirmed diagnosis of diabetes mellitus. * Long-term use of semaglutide (for at least 4 weeks) without discontinuation prior to endoscopic examination. * Age ≥ 18 years, with no restriction on sex. * American Society of Anesthesiologists (ASA) physical status classification I-II. * Fasting for at least 8 hours and no water intake for at least 4 hours prior to gastroscopy. * Underwent assessment for both autonomic and peripheral neuropathy within 2 weeks prior to gastroscopy, with a clear determination of neuropathy status. Exclusion Criteria: * History of hiatal hernia or any prior gastric surgery (including gastrectomy, Roux-en-Y gastric bypass, etc.). * Pregnancy. * Medically unfit for gastrointestinal endoscopy. * Deemed unsuitable for participation at the discretion of the investigators.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy gastroparesis type 2 diabetes mellitus

As listed by the trial registrant

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

Gastric retention

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

  • Huadong hospital, Fudan university

    Shanghai, Shanghai Municipality, 200040, China

More trials for these conditions

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