Diabetes MellitusPhase 2RESENSENCT06976658
Glucokinase Activator in Monogenic Diabetes
A Phase 2 study testing Dorzagliatin in people with Diabetes Mellitus and Monogenic Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Monogenic Diabetes
- What is being tested?
- Dorzagliatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Apr 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and <75 years
- body mass index (BMI) >18 and <30 kg/m2
- fasting plasma glucose >5.6 mmol/L at screening
- 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) .
Who cannot join
- Body weight <45kg at screening
- Current or planning pregnancy or lactating
- troke or cardiovascular disease within 6 months of recruitment
- severe renal dysfunction (estimated glomerular filtration rate <30mL/min/1.73m2 or renal replacement therapy)
- severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase > 3 times upper limit of normal)
- history of drug abuse or excessive alcohol intake
Show all 13Show fewer
- severe hypoglycemia within 6 months prior to screening
- anaemia with Hb <10 g/dL at screening
- excessive blood loss >300mL within 1 month of screening
- use of strong or moderate CYP3A4 inhibitors or inducers
- 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
- use of long-term high-dose corticosteroids at randomisation
- serious concurrent infections at time of screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
3M, Diabetes and Endocrine Research Center
Hong Kong
Michelle Luk, +852 35052648, michelleluk@cuhk.edu.hk
About this study
Official title: Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Read the detailed description
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
- Conditions
- Diabetes Mellitus, Monogenic Diabetes
- Being tested
- Dorzagliatin, matched placebo
- Keywords
- GCK-MODY, glucokinase activator
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DorzagliatinDrug
Dorzagliatin 50mg bd
matched placeboDrug
matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | active drug or placebo in a cross over randomised sequence Receives: Drug: Dorzagliatin |
| placebo | Placebo comparator | placebo in a cross over randomised sequence Receives: Drug: matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose
Difference in fasting plasma glucose (FPG) between treatment periods
Measured: 8 weeks
Secondary outcomes (6)
• HbA1c
Difference between HbA1c at end of treatment periods
Measured: 8 weeks
CGM metrics time in range
Time in range defined by CGM at end of treatment periods
Measured: 8 weeks
CGM metric coefficient of variation
Difference in % CV at end of treatment periods
Measured: 8 weeks
Glucose area under the curve during OGTT
Difference between AUC glucose at end of treament periods
Measured: 8 weeks
Insulin area under the curve during OGTT
Difference between AUC insulin at end of treament periods
Measured: 8 weeks
GLP1 area under the curve during OGTT
Difference between AUC GLP-1 at end of treament periods
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Chow, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976658
- Sponsor's protocol ID
- RESENSE
- Acronym
- RESENSE
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial
- ClinicalTrials.gov ID
- NCT06976658
- Acronym / sponsor ID
- RESENSE / RESENSE
- Conditions
- Diabetes Mellitus, Monogenic Diabetes
- Keywords
- GCK-MODY, glucokinase activator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Detailed description
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Dorzagliatinactive drug or placebo in a cross over randomised sequence |
| placebo | Placebo comparator | Drug: matched placeboplacebo in a cross over randomised sequence |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 and <75 years
- body mass index (BMI) >18 and <30 kg/m2
- fasting plasma glucose >5.6 mmol/L at screening
- 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) .
Key exclusion criteria (13 listed)
- Body weight <45kg at screening
- Current or planning pregnancy or lactating
- troke or cardiovascular disease within 6 months of recruitment
- severe renal dysfunction (estimated glomerular filtration rate <30mL/min/1.73m2 or renal replacement therapy)
- severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase > 3 times upper limit of normal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DorzagliatinDorzagliatin 50mg bd | Drug | Intervention |
| matched placebomatched placebo | Drug | placebo |
Primary outcome
Fasting plasma glucose
Time frame: 8 weeks
Difference in fasting plasma glucose (FPG) between treatment periods
6 secondary outcomes
• HbA1c
Time frame: 8 weeks
CGM metrics time in range
Time frame: 8 weeks
CGM metric coefficient of variation
Time frame: 8 weeks
Glucose area under the curve during OGTT
Time frame: 8 weeks
Insulin area under the curve during OGTT
Time frame: 8 weeks
GLP1 area under the curve during OGTT
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dorzagliatin in people with Diabetes Mellitus and Monogenic Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine Chow, MD (+852 35051641, e.chow@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.