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Can a shingles vaccine and diabetes drug save insulin cells?

NCT ID NCT07614412

Disease control Sponsor: Ministry of Health, Saudi Arabia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the shingles vaccine Shingrix and the diabetes drug semaglutide, alone or together, can help preserve the body's ability to make insulin in adults recently diagnosed with type 1 diabetes. The goal is to slow the immune attack on insulin-producing cells and protect them from damage. About 240 adults aged 18 to 50 who were diagnosed within the last 100 days will take part. The main measure is how well the pancreas responds to a meal test after one year.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 50 years

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. Diagnosis of Type 1 Diabetes (T1D) according to American Diabetes Association (ADA) criteria. 2. Age 18 to 50 years (inclusive) at the time of screening. 3. Randomization within 100 days of the first insulin injection. 4. Confirmed residual beta-cell function, defined as a peak stimulated C-peptide level ≥0.2 nmol/L during a Mixed Meal Tolerance Test (MMTT) performed at screening. 5. Presence of at least one T1D-related autoantibody (GADA, IA-2A, ZnT8A, or ICA). 6. Willingness to comply with intensive insulin therapy and glucose monitoring. 7. Females of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception. Exclusion Criteria: 1. History of diabetic ketoacidosis (DKA) within 4 weeks of screening. 2. Prior use of any immunotherapy or investigational agents for T1D. 3. Current or prior use of GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors. 4. History of pancreatitis or medullary thyroid carcinoma. 5. Active or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis). 6. Pregnancy or breastfeeding. 7. Significant renal, hepatic, or cardiovascular disease. 8. History of severe allergic reaction to any component of the Recombinant Zoster Vaccine (Shingrix) or semaglutide. 9. Current use of systemic corticosteroids or other immunosuppressive medications.

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Conditions

The condition(s) this trial relates to.

autoimmune disease type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes mellitus

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

  • Ministry of Health Medical City

    Riyadh, Saudi Arabia

More trials for these conditions

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