Type 2 DiabetesPhase 1NCT07234864
Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.
A Phase 1 study testing ZE63-0302 in people with Type 2 Diabetes, run by Eilean Therapeutics at 10 sites in 3 countries.
Trial summary
A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of ZE63-0302 administrated orally in T2DM patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ZE63-0302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 19 Nov 2025to Nov 2026
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females, ≥18 to ≤65 years of age (inclusive) at screening.
- Diagnosis of T2DM of at least 7 years at the time of screening.
- Must be receiving treatment with up to 3 antidiabetic agents (except insulin) at a stable, optimal, or maximum tolerated dose for at least 3 months prior to screening and with no dose changes expected during the study.
- Must have HbA1c ≥7.5% and ≤9.5% at the screening visit.
- Must have BMI ≥ 22.5 and ≤38.5 kg/m2 at the screening visit, with stable (± 5%) body weight within the previous 3 months of screening.
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- Female volunteers:
- Must be of non-childbearing potential, i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone [FSH] level consistent with postmenopausal status, per local laboratory guidelines), or
- If of childbearing potential, must:
- Have a negative pregnancy test at the screening visit and on Day 1. ii. Agree not to attempt to become pregnant or donate ova from signing the informed consent form (ICF) until at least 33 days after the last dose of study drug.
- Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from one month prior to screening until at least 33 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
- Male volunteers:
- Must agree not to donate sperm from signing the ICF until at least 93 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the ICF until at least 93 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom from signing the ICF until at least 3 days after the last dose of study drug.
- Have suitable venous access for blood sampling, as determined by the investigator (or delegate).
- Willing and able to comply with all study assessments, including performing SMPG and completing a study diary, and adhere to the protocol schedule and restrictions.
Who cannot join
- Diagnosis of diabetes other than T2DM (e.g., type 1 diabetes, latent autoimmune diabetes of adults, monogenic diabetes, gestational diabetes) or at least one of the following at screening:
- Fasting C-peptide <0.8 ng/mL
- Fasting insulin >50 µIU/mL
- Treatment with insulin within 3 months prior to or during screening.
- Severe hypoglycaemia (defined as the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery), hypoglycaemia unawareness, diabetic ketoacidosis, or non-ketotic hyperosmolar state within 3 months of screening.
- Use of weight loss agents (Section 21.2) or diet (hypocaloric diet), unless the diet or weight loss treatment (prescription, herbal, over-the-counter, or other) has been stopped at least 3 months prior to screening and the participant has had stable (± 5%) body weight within the previous 3 months of screening.
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- Chronic systemic corticosteroid use, defined as any daily dose >10 mg prednisone or equivalent, for more than 2 consecutive weeks within 3 months prior to or during screening.
- Note: Topical, inhaled, ocular, nasal, or other non-systemic corticosteroid use is allowed.
- Any use of hepatotoxic drugs (e.g., statins), gastric acid reducing medications, medications metabolized via the cytochrome P450 system (e.g., P-gp inhibitors, antifungal agents [ketoconazole, itraconazole], macrolides [erythromycin, clarithromycin], calcium channel blockers [verapamil, diltiazem], or medications with the potential for drug-drug interactions) within 3 months of screening.
- Personal or family history (first-degree relative) of multiple endocrine neoplasia type 1.
- History of or current acute or chronic pancreatitis or pancreatectomy.
- History of or current liver cirrhosis, liver transplant, or any other liver disease including, but not limited to, the following: alcoholic liver disease, autoimmune or viral hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitryspin deficiency requiring treatment.
- Note: Metabolic dysfunction-associated liver disease/metabolic dysfunction associated steatohepatitis without portal hypertension or cirrhosis and with acceptable liver function test results, as determined by the investigator (or delegate), is not exclusionary.
- Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the gastrointestinal tract (including weight-reducing surgery and procedures) that could affect the interpretation of study data, as determined by the Investigator (or delegate).
- Note: Appendectomy, hernia repair, cholecystectomy, and similar conditions, as determined by the investigator (or delegate), are not exclusionary.
- Any of the following events or conditions within 3 months prior to or during screening: hospitalisation due to unstable angina, myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angioplasty, transient ischemic attack or significant cerebrovascular disease, or symptomatic heart failure (New York Heart Association Class III or IV).
- Mean QT interval corrected using the Fridericia method (QTcF) >450 msec for men and >470 msec for women on screening ECG; or unstable, uncontrolled, or life-threatening arrhythmia or heart block, as assessed by the investigator (or delegate).
- Untreated or unstable hypertension, defined as systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg after 10 minutes of supine rest and confirmed by repeated measurement at screening. Individuals with blood pressure above this threshold may have blood pressure-lowering medication(s) initiated and/or adjusted and be rescreened.
- Any history of malignant disease in the last 5 years (excludes surgically resected squamous cell or basal cell carcinoma of the skin and cervical cancer in situ that have been treated with potentially curative therapy).
- History of or current haemoglobinopathy (e.g., sickle cell anaemia, thalassaemia major, sideroblastic anaemia) or any other clinically important haematological abnormality (e.g., leucopoenia, thrombocytopaenia) as judged by the investigator (or delegate).
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months of screening, as determined by the investigator (or delegate) to be clinically relevant.
- Any of the following laboratory abnormalities at screening:
- Aspartate aminotransferase ≥1.5 × upper limit of normal range (ULN)
- Alanine aminotransferase ≥1.5 × ULN
- Alkaline phosphatase (ALP) ≥1.5 × ULN
- Total bilirubin ≥1.5 × ULN (except for Gilbert's syndrome, which is not exclusionary, provided that direct (conjugated) bilirubin is ≤ ULN)
- Haemoglobin <11.5 g/dL (115 g/L) for males and <10.5 g/dL (105 g/L) for females
- Estimated glomerular filtration rate ≤60 mL/minute/1.73 m2 as defined by the Chronic Kidney Disease Epidemiology Collaboration formula
- Fasting triglycerides >400 mg/dL at screening Note: Individuals who fail screening based on this criterion must have their fasting status verified by the investigator (or delegate) and may have triglyceride-lowering medications adjusted and be retested during the screening window.
- Lipase and/or amylase ≥1.5 × ULN
- Thyroid stimulating hormone >6 mIU/L Note: Laboratory abnormalities (except for any exclusionary liver function test result) can be repeated once during the screening window at the discretion of the investigator (or delegate), if there is reasonable belief that the exclusionary result was obtained in error or is transient.
- A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at the screening visit.
- Known or suspected history of alcohol or drug abuse within the past 3 years as judged by the investigator (or delegate).
- Note: Individuals on stable methadone or buprenorphine maintenance treatment for at least 12 months prior to screening may be included in the study.
- Binge drinking behaviour or significant alcohol consumption, defined as consumption of >21 units/week if male and >14 units/week if female for a period of more than 3 consecutive months within 1 year prior to screening.
- Known hypersensitivity to any of the proposed study treatments or ingredients/excipients.
- Females who are breastfeeding or planning to breastfeed.
- Donation of blood or plasma of ≥450 mL or loss of whole blood of ≥450 mL within 60 days prior to Day 1, or receipt of a blood transfusion within 60 days of Day 1, that may interfere with HbA1c determination.
- Use of any vaccinations within 30 days prior to screening.
- Administration of any investigational drug or participation in another interventional clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
- Note: Participation in an observational research study is not exclusionary.
- Individuals who are employees, or close relative of an employee, of the Sponsor, CRO, or the study site, regardless of the employee's role.
- Unavailability for follow-up assessments (e.g., planned major surgery during the study, relocation for job or family reasons) or concern for willingness or ability to follow study procedures (e.g., inability to complete long OGTT study visits, variable work schedule, travel, or shift work)
- Any other condition or prior therapy that, in the opinion of the PI (or delegate), would make the individual unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements, or would interfere with evaluation of the study drug, put the individual at risk, or affect the interpretation of the results of the study.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
New Zealand5 sites
PCRN Christchurch
Christchurch, Canterbury, 8013
Momentum Dunedin
Dunedin, Otago, 9016
PCRN Waikato
Hamilton, Waikato Region, 3200
PCRN Rotorua
Rotorua, Bay of Plenty, 3010
Momentum Wellington
Wellington, Wellington Region, 6011
Australia4 sites
Emeritus Research Sydney
Botany, New South Wales, 2019
Momentum Clinical Research Taringa
Brisbane, Queensland, 4068
Momentum Clinical Research Sunshine
Melbourne, Victoria, 3021
Emeritus Research Camberwell
Melbourne, Victoria, 3124
Uzbekistan1 site
The Republican Specialized Scientific and Prectical Medical Center of Endocrinology named after Academician Yo. Kh. Turakulov
Tashkent, Tashkent, 100125
About this study
Official title: An Exploratory Randomised, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE63-0302 in Participants With Type 2 Diabetes Mellitus
A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of ZE63-0302 administrated orally in T2DM patients.
Read the detailed description
This is an exploratory randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 4-week treatment with ZE63-0302 versus placebo in participants with T2DM managed with up to 3 antidiabetic agents (except for insulin). Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. In this study patients will be enrolled to receive BID of ZE63-0302 or Placebo under fasted condition.
- Conditions
- Type 2 Diabetes
- Being tested
- ZE63-0302, Placebo
- Keywords
- Type 2 diabetes, menin-inhibitor, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZE63-0302Drug
Oral capsules BID
PlaceboDrug
Oral capsules BID
| Study group | Role | What they receive |
|---|---|---|
| ZE63-0302 treatment | Experimental | Oral capsules BID Receives: Drug: ZE63-0302 |
| Placebo | Placebo comparator | Oral capsules BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE/SAE.
To assess the incidence of adverse events and serious adverse events.
Measured: From dosing to Week 4.
Change from baseline throughout the study in the vital signs and physical examination findings.
Measured: From dosing to Week 4.
Change from baseline throughout the study in 12-lead electrocardiogram results
Measured: From dosing to Week 4
Change from baseline throughout the study in Clinical laboratory assessments.
Measured: From dosing to Week 4.
Secondary outcomes (7)
Half-life (t1/2) of ZE63-0302
Measured: PK samples will be collected 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Plasma Cmax
ZE63-0302 peak plasma concentration
Measured: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose
Time to maximum concentration.
ZE63-0302 time to maximum concentration.
Measured: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Area under the concentration time curve from time 0 to 12 hours
Measured: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Area under the concentration time curve from time 0 to 6 hours
Measured: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Trough plasma concentration
Measured: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Accumulation ratio.
Measured: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start19 Nov 2025
- Primary completion21 Apr 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eilean Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234864
- Sponsor's protocol ID
- ZE63-0302-0002
- Status last verified
- May 2026
- First submitted
- 25 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomised, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE63-0302 in Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07234864
- Acronym / sponsor ID
- ZE63-0302-0002
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, menin-inhibitor, type 2 diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eilean TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Nov 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.
A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of ZE63-0302 administrated orally in T2DM patients.
Detailed description
This is an exploratory randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 4-week treatment with ZE63-0302 versus placebo in participants with T2DM managed with up to 3 antidiabetic agents (except for insulin). Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. In this study patients will be enrolled to receive BID of ZE63-0302 or Placebo under fasted condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZE63-0302 treatment | Experimental | Drug: ZE63-0302Oral capsules BID |
| Placebo | Placebo comparator | Drug: PlaceboOral capsules BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females, ≥18 to ≤65 years of age (inclusive) at screening.
- Diagnosis of T2DM of at least 7 years at the time of screening.
- Must be receiving treatment with up to 3 antidiabetic agents (except insulin) at a stable, optimal, or maximum tolerated dose for at least 3 months prior to screening and with no dose changes expected during the study.
- Must have HbA1c ≥7.5% and ≤9.5% at the screening visit.
Key exclusion criteria (44 listed)
- Diagnosis of diabetes other than T2DM (e.g., type 1 diabetes, latent autoimmune diabetes of adults, monogenic diabetes, gestational diabetes) or at least one of the following at screening:
- Treatment with insulin within 3 months prior to or during screening.
- Severe hypoglycaemia (defined as the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery), hypoglycaemia unawareness, diabetic ketoacidosis, or non-ketotic hyperosmolar state within 3 months of screening.
- Use of weight loss agents (Section 21.2) or diet (hypocaloric diet), unless the diet or weight loss treatment (prescription, herbal, over-the-counter, or other) has been stopped at least 3 months prior to screening and the participant has had stable (± 5%) body weight within the previous 3 months of screening.
- Chronic systemic corticosteroid use, defined as any daily dose >10 mg prednisone or equivalent, for more than 2 consecutive weeks within 3 months prior to or during screening.
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 |
|---|---|---|
| ZE63-0302Oral capsules BID | Drug | ZE63-0302 treatment |
| PlaceboOral capsules BID | Drug | Placebo |
Primary outcome
Incidence of AE/SAE.
Time frame: From dosing to Week 4.
To assess the incidence of adverse events and serious adverse events.
Change from baseline throughout the study in the vital signs and physical examination findings.
Time frame: From dosing to Week 4.
Change from baseline throughout the study in 12-lead electrocardiogram results
Time frame: From dosing to Week 4
Change from baseline throughout the study in Clinical laboratory assessments.
Time frame: From dosing to Week 4.
7 secondary outcomes
Half-life (t1/2) of ZE63-0302
Time frame: PK samples will be collected 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Plasma Cmax
Time frame: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose
Time to maximum concentration.
Time frame: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Area under the concentration time curve from time 0 to 12 hours
Time frame: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Area under the concentration time curve from time 0 to 6 hours
Time frame: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Trough plasma concentration
Time frame: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
Accumulation ratio.
Time frame: PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.
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 11 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZE63-0302 in people with Type 2 Diabetes, run by Eilean Therapeutics at 10 sites in 3 countries.
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 17 inclusion and 44 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in New Zealand, Australia, Uzbekistan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AE/SAE. (time frame: From dosing to Week 4.). The study lists 4 primary outcomes in all. 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 11 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.