Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.

NCT07234864 | Recruiting Phase 1

• 1 other identifier: ZE63-0302-0002
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; menin-inhibitor; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (4)

• Incidence of AE/SAE.

  To assess the incidence of adverse events and serious adverse events.

  From dosing to Week 4.

• Change from baseline throughout the study in the vital signs and physical examination findings.

  From dosing to Week 4.

• Change from baseline throughout the study in 12-lead electrocardiogram results

  From dosing to Week 4

• Change from baseline throughout the study in Clinical laboratory assessments.

  From dosing to Week 4.

Secondary Outcomes (7)

• Half-life (t1/2) of ZE63-0302

  PK samples will be collected 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.

• Plasma Cmax

  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.

  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

  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

  PK samples will be collected within 15 minutes prior to dosing with ZE63-0302/Placebo to Day 28 6 hours post-dose.

Other Outcomes (9)

• Absolute and percent change from baseline in Haemoglobin A1c and Fasting blood glucose.

  From dosing to Week 4

• Absolute and percent change from baseline in Fasting insulin, fasting C peptide, fasting glucagon, fasting C peptide-to-glucose ratio, and fasting proinsulin to-insulin ratio

  From dosing to Week 4

• Percent change from baseline to Week 12 in the AUC0 2h of Glucose, Insulin, C peptide, Glucagon, Incretin after OGTT.

  From dosing to Week 4

Study Arms (2)

ZE63-0302 treatment

EXPERIMENTAL

Oral capsules BID

Drug: ZE63-0302

Placebo

PLACEBO COMPARATOR

Oral capsules BID

Drug: Placebo

Interventions

ZE63-0302 DRUG

Oral capsules BID

ZE63-0302 treatment

Placebo DRUG

Oral capsules BID

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• i. 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.
• iii. 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.

You may not qualify if:

• 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.
• 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.
• 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).
• 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).

Sponsors & Collaborators

• Eilean Therapeutics: lead

Study Sites (5)

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

RECRUITING

Momentum Clinical Research Taringa

Brisbane, Queensland, 4068, Australia

NOT YET RECRUITING

Momentum Clinical Research Sunshine

Melbourne, Victoria, 3021, Australia

NOT YET RECRUITING

Emeritus Research Camberwell

Melbourne, Victoria, 3124, Australia

RECRUITING

The Republican Specialized Scientific and Prectical Medical Center of Endocrinology named after Academician Yo. Kh. Turakulov

Tashkent, Tashkent, 100125, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ekaterina Dokukina

CONTACT

+38269728309; kdokukina@eilenther.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 19, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); UZ (1)