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Can a weekly shot help dialysis patients control diabetes?

NCT ID NCT06042153

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether semaglutide, a once-weekly injection, can improve blood sugar control in people with type 2 diabetes who are on chronic dialysis. About 43 participants will receive either semaglutide or a placebo for over a year, and their blood sugar levels will be tracked using a continuous glucose monitor. The goal is to see if semaglutide helps keep blood sugar in a healthy range without causing dangerous lows.

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 offer a new way to manage blood sugar in people with diabetes who are on dialysis, potentially improving their health and quality of life.
What could go wrong
This is a small, early-phase study with only 43 participants, so results may not apply to everyone. Semaglutide can cause side effects like nausea or vomiting, and its safety in dialysis patients is not fully known.

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

43 people

The number who actually took part.

Started

Dec 2023

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.

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: 1. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedures that are carried out as a part of trial, including activities to determine suitability for the trial. 2. Male or female Adults (age \> 18 years at the time of signing the consent) 3. Type 2 diabetes mellitus diagnosed \> 6 months prior to screening 4. On current chronic treatment with Hemodialysis or Peritoneal dialysis for \> 6 months prior to screening 5. Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at randomization. 6. Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download 7. Time in Range 15 to 60% Exclusion Criteria: 1. BMI \< 23 kg/m2 at screening 2. Current (within the past 90 days of screening) use of any GLP-1 RA 3. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2 4. Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products) 5. Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures 6. Active weight loss, defined as weight loss of \>5% of body weight in the past 3 months 7. Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization 8. Any medical condition which in the judgement of the investigator precludes safe participation in the trial (includes, but not limited to active neoplasm, severe heart failure, recent cardiovascular event, severe frailty, planned cardiac or vascular surgeries on the day of screening etc) 9. If weight loss is not desired by the participant, or if the provider or investigator considers intentional weight loss to be detrimental to the health of the participant 10. Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.) 11. Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA. 12. Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator) 13. Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening 14. Known current uncontrolled or unstable retinopathy (by medical history)

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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.

Contacts and locations

Locations

  • DaVita UT Southwestern - East Dallas

    Dallas, Texas, 75228, United States

  • DaVita UT Southwestern - Irving

    Irving, Texas, 75062, United States

  • DaVita UT Southwestern - Preston

    Dallas, Texas, 75240, United States

  • Davita UT Southwestern - Oak Cliff

    Dallas, Texas, 75224, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

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