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Can a popular diabetes drug help liver transplant patients control blood sugar?

NCT ID NCT05195944

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two diabetes medications, semaglutide and sitagliptin, in 58 adults who have had a liver transplant and have poorly controlled diabetes. The goal is to see which drug better lowers blood sugar and body weight. Participants will take the study drug daily for the trial duration, and all will continue standard post-transplant medications for life.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 58 people

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

Started

Oct 2022

Expected to finish

Dec 2026

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.

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: * Male or female, age ≥18 years at the time of signing informed consent. * Willing and able to provide informed consent. * Recipient of liver graft (Liver/Kidney recipients and retransplants allowed) * Time from transplant surgery ≥ 3 months at time of screening visit with no evidence of active rejection. Liver enzymes must be stable with elevations no greater than 2xULN. However, if patients have elevated liver enzymes beyond 2xULN due to NASH, as confirmed on liver biopsy, they may be included. * Patient diagnosed with type 2 diabetes or post-transplant diabetes * Patients transplanted for hepatocellular carcinoma may be included provide their latest surveillance imaging is negative for recurrence * The use of any immunosuppression regimen (calcineurin inhibitors, mycophenolate mofetil, maintenance prednisone or sirolimus) is acceptable * HbA1c 6.5-10.5% (53-91 mmol/mol) (both inclusive, not under optimal glycemic control). For purposes of clarification, patients on stable treatment with one of the following insulin regimens (minimum 10 IU/day) ≥ 90 days prior to the day of screening, may be included (maximum 20% change in total daily dose within the 90 days is acceptable): * Basal insulin alone * Basal and bolus insulin in any combination * Premixed insulin including combinations of soluble insulin Concomitant treatment with stable daily dose of metformin and/or an SGLT2 inhibitor ≥ 90 days prior to the day of screening is allowed. Being on insulin, metformin, and/or an SGLT-2 inhibitor is optional. Exclusion Criteria: * Known or suspected hypersensitivity to trial products or related products. * Previous participation in this trial. * Active graft dysfunction that requires investigation (at screening). * Currently receiving steroids (prednisone) for treatment of acute cellular rejection. * Patients transplanted for multisystem genetic disorders such as amyloidosis or cystic fibrosis. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly-effective contraceptive methods (). * Receipt of any investigational medicinal product within 90 days before screening. * Any disorder or medical condition which, in the investigator's opinion, might jeopardize patient's safety or compliance with the protocol. * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). * History of pancreatitis (acute or chronic). * History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). * Any of the following: myocardial infarction (MI), stroke or hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening and randomization. * Classified as being in New York Heart Association (NYHA) Class IV. * Planned coronary, carotid or peripheral artery revascularization known on the day of screening. * Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term change of insulin treatment for acute illness for a total of ≤ 14 days. * Known history of proliferative retinopathy or maculopathy requiring acute treatment, unless stable * History or presence of actively treated malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, hepatocellular carcinoma, and carcinoma in situ.)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2, Canada

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