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New pill could tame rare genetic diabetes

NCT ID NCT06976658

Disease control Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new drug called dorzagliatin in 44 adults with a rare, inherited form of diabetes (GCK-MODY). The drug works by activating a key enzyme to help the body better control blood sugar. Participants will receive both the drug and a placebo at different times to see if the drug improves blood sugar levels and other measures.

What this could mean

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

Active substance
Dorzagliatin (a drug that activates glucokinase, an enzyme that helps regulate blood sugar)
What this could lead to
If successful, this could provide a targeted oral treatment option for people with GCK-MODY, potentially improving blood sugar control without the need for insulin or other diabetes drugs.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 44 participants, so results may not apply to everyone. The drug may not significantly improve blood sugar or could have side effects. It is not a cure, as ongoing treatment would likely be needed.

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 44 people

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

Started

Apr 2025

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 to 74 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. Age ≥18 and \<75 years 2. body mass index (BMI) \>18 and \<30 kg/m2 3. fasting plasma glucose \>5.6 mmol/L at screening 4. Participants with GCK-MODY had and are heterozygous carriers of a pathogenic or likely pathogenic GCK mutation at screening based on guidelines published by the American College of Medical Genetics and Genomics (ACMG), Association for Clinical Genomic Science (ACGS) and the ClinGen Monogenic Diabetes Expert Panel (MDEP) . Exclusion Criteria: 1. Body weight \<45kg at screening 2. Current or planning pregnancy or lactating 3. troke or cardiovascular disease within 6 months of recruitment 4. severe renal dysfunction (estimated glomerular filtration rate \<30mL/min/1.73m2 or renal replacement therapy) 5. severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase \> 3 times upper limit of normal) 6. history of drug abuse or excessive alcohol intake 7. severe hypoglycemia within 6 months prior to screening 8. anaemia with Hb \<10 g/dL at screening 9. excessive blood loss \>300mL within 1 month of screening 10. use of strong or moderate CYP3A4 inhibitors or inducers 11. use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation 12. use of long-term high-dose corticosteroids at randomisation 13. serious concurrent infections at time of screening

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Conditions

The condition(s) this trial relates to.

diabetes mellitus maturity-onset diabetes of the young type 2 monogenic diabetes

As listed by the trial registrant

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

Diabetes mellitus Monogenic diabetes

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

  • 3M, Diabetes and Endocrine Research Center

    RECRUITING

    Hong Kong, Hong Kong

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