Home › Trials › NCT06976658
Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 74

Dorzagliatin for glucokinase (GCK-MODY) diabetes

Official title: Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial

Run by Chinese University of Hong Kong · NCT06976658 · Data updated 2026-11-12

This trial will test whether dorzagliatin, a drug that activates glucokinase, can lower blood sugar in adults with GCK-MODY caused by an inactivating GCK mutation.

More Diabetes Mellitus trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 74 Years
SexAll
Enrollment44 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedApril 30, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 30, 2026
Trial IDNCT06976658 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–74 who are heterozygous carriers of a pathogenic or likely pathogenic GCK mutation, have BMI 18–30 kg/m2, fasting plasma glucose >5.6 mmol/L, and meet organ function and safety criteria are the intended candidates.

Probably not a fit

People without GCK mutations, those with severe renal or hepatic dysfunction, pregnancy or recent cardiovascular events, or those with recent severe hypoglycaemia are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled cross-over trial enrolling adults who are heterozygous for pathogenic or likely pathogenic GCK mutations and have mild fasting hyperglycemia. Participants receive dorzagliatin and matched placebo in separate treatment periods with washout between periods to compare within-person glucose responses. Key eligibility includes age 18–74, BMI 18–30 kg/m2, fasting plasma glucose >5.6 mmol/L, and adequate renal and hepatic function. Major exclusions are pregnancy, recent cardiovascular events, severe renal or hepatic dysfunction, recent severe hypoglycaemia, or substance misuse.

Why it matters

Potential benefit: If successful, dorzagliatin could lower fasting glucose and improve day-to-day glycemic control in people with GCK-MODY, potentially reducing the need for other glucose-lowering measures in this group.

How similar studies have gone: Some glucokinase activators have lowered glucose in type 2 diabetes but showed mixed durability and safety signals, and targeted trials in GCK-MODY are limited, so this application is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • 3M, Diabetes and Endocrine Research Center
    Hong Kong, Hong Kong     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Diabetes Mellitus 218Monogenic Diabetes 5Chinese University of Hong Kong 279
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.