Type 2 Diabetes MellitusPhase 1NCT05491421
A Study of ZT002 in Healthy Participants
A Phase 1 study testing ZT002 in people with Type 2 Diabetes Mellitus, run by QL Biopharmaceutical Australia Pty Ltd at 1 site in Australia.
Trial summary
This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- ZT002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Sep 2022to 28 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, age 18-55 years, both inclusive, at time of informed consent
- Body Mass Index (BMI) between 22.0～35.0 kg/m2 both included. For the MAD portion only, participants with BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥ 80 kg will be included.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and before administration of study drug, as assessed by the Investigator
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
- Has no relevant dietary restrictions (not including those common restrictions that can be easily accommodated, i.e., veganism, vegetarianism, halal, etc.), and willing to consume standard meals within the options provided by the site
- Male participants must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a woman of childbearing potential (WOCBP), the participant must be surgically sterile (>30 days since vasectomy with no viable sperm) or the participant and his partner must be using an acceptable, highly effective contraceptive method from 4 weeks prior to dosing until study completion, including the follow-up period.
Show all 11Show fewer
- Female participants that are WOCBP must be non-pregnant and non-lactating, and using an acceptable, highly effective contraceptive method from 4 weeks prior to dosing until study completion, including the follow-up period, OR must be abstinent from heterosexual intercourse OR their partner must be surgically sterile (>30 days since vasectomy with no viable sperm), provided the male partner is a sole partner.
- Female participants that are not WOCBP must have documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), OR must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants.
- Acceptable methods of contraception include the use of condoms AND the use of an effective contraceptive for the female partner that includes: oral contraceptive pill (OCPs), long acting implantable hormones, injectable hormones, contraceptive patches, a vaginal ring or an intrauterine device (IUD).
- Participants with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle, and no contraception is required.
- Male participants agree not to donate sperm for at least 90 days after the last dose of study drug.
Who cannot join
- History of significant drug allergy or drug hypersensitivity.
- Known or suspected allergy to trial product or related products.
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee), that could adversely affect the safety of the participant or their likelihood to comply with the protocol or complete the study per protocol. Fully resolved childhood asthma is not exclusionary. Gestational diabetes is exclusionary.
- eGFR value ≤90 mL/min/1.73m2 using the MDRD equation.
- Clinically significant abnormal laboratory test results during the Screening and before administration of study drug, as judged by the Investigator.
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the participant.
Show all 33Show fewer
- History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
- History of acute or chronic pancreatitis.
- Calcitonin equal or above 50 ng/L at screening.
- Fever (body temperature >37.5°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening and Day -1.
- History of severe allergic or anaphylactic reactions.
- QTcF > 450 ms for male participants or > 470 ms for female participants, or any other abnormal ECG findings that are considered by the Investigator to be clinically significant, at Screening and before administration of study drug.
- History or presence of a condition associated with significant immunosuppression.
- History of life -threatening infection (e.g. meningitis).
- Infections requiring parenteral antibiotics within the 6 months prior to Screening.
- History of drug/chemical substance abuse within 1 year from Screening.
- Positive alcohol breath test result, or positive urine drug screen (confirmed by repeat), at Screening or check-in.
- Regular alcohol consumption (by self-declaration) in the past 6 months, defined as greater than 21 alcohol units per week for males and 14 units per week for females (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- Unwilling to abstain from alcohol consumption from 24 hours prior to admission to the CRU, during the residency period, and 24 hours prior to each non-residential visit.
- Have smoked >5 cigarettes or use the equivalent tobacco or nicotine containing products per day in the past 1 month prior to Screening (vaping with nicotine containing vapes included) or unable or unwilling to refrain from smoking and use of nicotine substitute products until after the final study visit, as judged by the Investigator.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
- Previously dosed in a clinical trial involving this or other IPs within the last 3 months before dosing.
- Blood donation or considerable blood loss - more than 400 mL, during the 3 months prior to study start, and plasma donation within 7 days prior to study start.
- Systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <40 mmHg, and pulse rate >100 or <40 beats per minute. Abnormal values should be confirmed by a repeat measurement (one repeat only).
- Impaired hepatic function measured as ALT (Alanine aminotransferase), AST (Aspartate aminotransferase), alkaline phosphatase above 1.5 times the upper reference limit (one retest of the initial test is permitted, the last result being conclusive).
- Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycemic episodes within 12 months prior to Screening, and any current or prior use of insulin secretagogues (e.g., sulfonylurea) or insulin.
- Impaired glucose tolerance results for oral glucose tolerance test (OGTT) performed at screening. A blood glucose level ≥7.8 mmol/L at 2 hours will be considered as impaired glucose tolerance.
- Those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated within 4 weeks of dosing, except for COVID-19 and influenza vaccines, exclusionary when the participant is scheduled to be vaccinated within 1 week of dosing.
- Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical trial) within the 4 months prior to Screening or 5 half-lives, whichever is longer.
- Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, supplements, acetylsalicylic acid, paracetamol and contraceptives; herbal preparations or dietary supplements that are specifically marketed for control of body weight or appetite remain excluded) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the dosing and for the duration of the study. Paracetamol/acetaminophen (1-2 therapeutic doses per week) may be used for minor ailments during the course of the study, at the discretion of the Investigator.
- Poor peripheral venous access.
- Participant is unwilling to refrain from strenuous exercise (including weightlifting) from 48 hours prior to admission to the investigational site until completion of the residency (inpatient) period, and from 48 hours prior to the Day 15, Day 29, Day 43, and Day 71/Early Withdrawal visits.
- Any disorder or other circumstance which in the Investigator's opinion might jeopardize participant's safety, evaluation of results, or compliance with the protocol, meaning that, in the opinion of the Investigator (or designee), the participant should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Parallel Assignment, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of ZT002 in Healthy Participants
This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.
Read the detailed description
This study is planned to be conducted in 2 portions: single ascending dose and multiple ascending doses.
For the SAD portion, there are a total of 4 cohorts. In each cohort 6 participants will receive ZT002, and 2 participants will receive placebo, for a total of 8 participants in each cohort.
For the MAD portion, the study is planned to be conducted in healthy participants with a BMI range of 26kg/m^2 to 40kg/m^2 and a body weight of >/= 80kg. This portion is planned to be conducted in 3 cohorts (Cohort 1 to 3), 6 participants will receive ZT002, and 2 participants will receive placebo, across of total of 8 participants (for a total of 24 participants across 3 cohorts). In each cohort, 3 escalating doses of ZT002 are planned. Dosing is planned to be administered every 2 weeks (Q2W).
Potential participants will be screened to assess their eligibility to enter the study in a Screening period from days -28 to -2, prior to the scheduled treatment on Day 1.
A Safety Monitoring Committee (SMC) meeting to discuss dose escalation will be held after each cohort
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ZT002, Placebo
- 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.
ZT002Drug
Participants will receive a single subcutaneous (SC) ZT002 dose of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under fasted conditions.
Participants will MAD Cohorts will receive a single subcutaneous (SC) ZT002 in following doses under fasting conditions-
- Cohort 1: 7.0mg, 10mg, 20mg;
- Cohort 2: 10 mg, 20mg, 40mg;
- Cohort 3: To be decided post safety review meetings
PlaceboOther
Participants will receive same volume as of the study drug of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under the fasted condition.
Participants in MAD cohorts will receive same volume as study drug in the following cohorts under fasted condition-
- Cohort 1: 7.0mg, 10mg, 20mg;
- Cohort 2: 10 mg, 20mg, 40mg;
- Cohort 3: To be decided post safety review meetings
| Study group | Role | What they receive |
|---|---|---|
| A (ZT002) | Experimental | Drug: ZT002
Dose level:
SAD dose (Cohort 1-4)
* 0.03 mg/kg, 0.09 mg/kg, 0.18 mg/kg, 0.3 mg/kg;
MAD dose (Cohort 1-3)
* Cohort 1: 7.0mg, 10mg, 20mg;
* Cohort 2: 10 mg, 20mg, 40mg;
* Cohort 3: To be decided post safety review meetings
Dose: Subcutaneous Injection Receives: Drug: ZT002 |
| B (Placebo) | Placebo comparator | Dose level:
SAD dose (Cohort 1-4)
* 0.03 mg/kg, 0.09 mg/kg, 0.18 mg/kg, 0.3 mg/kg;
MAD dose (Cohort 1-3)
* Cohort 1: 7.0mg, 10mg, 20mg;
* Cohort 2: 10 mg, 20mg, 40mg;
* Cohort 3: To be decided post safety review meetings
Dose: Subcutaneous Injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to 71 days
Safety and tolerability of a single escalation dose of ZT002 through the incidence severity of serious adverse events in SAD Cohorts. Number of participants with serious adverse events.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to 71 days
To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through number of participants with treatment emergent adverse events in MAD Cohorts.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: up to 85 days
To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through incidence severity of serious adverse events in MAD Cohorts.
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Upto 85 days
Secondary outcomes (5)
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD Cohorts. Parameter: Maximum observed plasma concentration of ZT002 (Cmax)
Measured: Up to 85 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD Cohorts. Parameter: Area under the drug-time curve from 0 h after dosing to the last quantifiable concentration time point (AUC0-last)
Measured: Up to 85 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD cohorts. Parameter: Area under the drug-time curve to infinity (AUC0-inf)
Measured: Up to 85 days
The anti-drug antibody (ADA) response through an anti-drug antibody assay in SAD and MAD cohorts.
Measured: Up to 85 days
The anti-drug antibody (ADA) response through testing serum or plasma of the participant post dosing in SAD and MAD cohorts.
Measured: Up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start2 Sep 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- QL Biopharmaceutical Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited, Beijing QL Biopharmaceutical Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Kristi McLendon, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491421
- Sponsor's protocol ID
- ZT002
- Status last verified
- Jan 2026
- First submitted
- 1 Aug 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Parallel Assignment, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of ZT002 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05491421
- Acronym / sponsor ID
- ZT002
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- QL Biopharmaceutical Australia Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited, Beijing QL Biopharmaceutical Co.,Ltd
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 8 Aug 2022 (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.
This study will comprise a randomized, parallel assignment, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in healthy participants.
Detailed description
This study is planned to be conducted in 2 portions: single ascending dose and multiple ascending doses.
For the SAD portion, there are a total of 4 cohorts. In each cohort 6 participants will receive ZT002, and 2 participants will receive placebo, for a total of 8 participants in each cohort.
For the MAD portion, the study is planned to be conducted in healthy participants with a BMI range of 26kg/m^2 to 40kg/m^2 and a body weight of >/= 80kg. This portion is planned to be conducted in 3 cohorts (Cohort 1 to 3), 6 participants will receive ZT002, and 2 participants will receive placebo, across of total of 8 participants (for a total of 24 participants across 3 cohorts). In each cohort, 3 escalating doses of ZT002 are planned. Dosing is planned to be administered every 2 weeks (Q2W).
Potential participants will be screened to assess their eligibility to enter the study in a Screening period from days -28 to -2, prior to the scheduled treatment on Day 1.
A Safety Monitoring Committee (SMC) meeting to discuss dose escalation will be held after each cohort
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (ZT002) | Experimental | Drug: ZT002Drug: ZT002 Dose level: SAD dose (Cohort 1-4) * 0.03 mg/kg, 0.09 mg/kg, 0.18 mg/kg, 0.3 mg/kg; MAD dose (Cohort 1-3) * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings Dose: Subcutaneous Injection |
| B (Placebo) | Placebo comparator | Other: PlaceboDose level: SAD dose (Cohort 1-4) * 0.03 mg/kg, 0.09 mg/kg, 0.18 mg/kg, 0.3 mg/kg; MAD dose (Cohort 1-3) * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings Dose: Subcutaneous Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female, age 18-55 years, both inclusive, at time of informed consent
- Body Mass Index (BMI) between 22.0～35.0 kg/m2 both included. For the MAD portion only, participants with BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥ 80 kg will be included.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and before administration of study drug, as assessed by the Investigator
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
- Has no relevant dietary restrictions (not including those common restrictions that can be easily accommodated, i.e., veganism, vegetarianism, halal, etc.), and willing to consume standard meals within the options provided by the site
Key exclusion criteria (33 listed)
- History of significant drug allergy or drug hypersensitivity.
- Known or suspected allergy to trial product or related products.
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee), that could adversely affect the safety of the participant or their likelihood to comply with the protocol or complete the study per protocol. Fully resolved childhood asthma is not exclusionary. Gestational diabetes is exclusionary.
- eGFR value ≤90 mL/min/1.73m2 using the MDRD equation.
- Clinically significant abnormal laboratory test results during the Screening and before administration of study drug, as judged by the Investigator.
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 |
|---|---|---|
| ZT002Participants will receive a single subcutaneous (SC) ZT002 dose of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under fasted conditions. Participants will MAD Cohorts will receive a single subcutaneous (SC) ZT002 in following doses under fasting conditions- * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings | Drug | A (ZT002) |
| PlaceboParticipants will receive same volume as of the study drug of 0.03, 0.09, 0.18, or 0.3 mg/kg respectively, for SAD Cohorts 1 to 4 under the fasted condition. Participants in MAD cohorts will receive same volume as study drug in the following cohorts under fasted condition- * Cohort 1: 7.0mg, 10mg, 20mg; * Cohort 2: 10 mg, 20mg, 40mg; * Cohort 3: To be decided post safety review meetings | Other | B (Placebo) |
Primary outcome
Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events.
Time frame: Up to 71 days
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
Safety and tolerability of a single escalation dose of ZT002 through the incidence severity of serious adverse events in SAD Cohorts. Number of participants with serious adverse events.
Time frame: Up to 71 days
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through number of participants with treatment emergent adverse events in MAD Cohorts.
Time frame: up to 85 days
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
To assess safety and tolerability of multiple escalation doses of ZT002 in healthy participants with a BMI range of 26 kg/m2 to 40 kg/m2 and a body weight of ≥80 kg through incidence severity of serious adverse events in MAD Cohorts.
Time frame: Upto 85 days
Coded by the most updated version of the Medical Dictionary for Regulatory Activities (MedDRA).
5 secondary outcomes
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD Cohorts. Parameter: Maximum observed plasma concentration of ZT002 (Cmax)
Time frame: Up to 85 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD Cohorts. Parameter: Area under the drug-time curve from 0 h after dosing to the last quantifiable concentration time point (AUC0-last)
Time frame: Up to 85 days
The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in healthy participants in SAD and MAD cohorts. Parameter: Area under the drug-time curve to infinity (AUC0-inf)
Time frame: Up to 85 days
The anti-drug antibody (ADA) response through an anti-drug antibody assay in SAD and MAD cohorts.
Time frame: Up to 85 days
The anti-drug antibody (ADA) response through testing serum or plasma of the participant post dosing in SAD and MAD cohorts.
Time frame: Up to 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Kristi McLendon principal investigator
Nucleus Network Pty Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZT002 in people with Type 2 Diabetes Mellitus, run by QL Biopharmaceutical Australia Pty Ltd at 1 site in Australia.
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 11 inclusion and 33 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: finished, as of the sponsor's last update on 16 Jan 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of a single escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in SAD Cohorts. Number of participants with treatment-emergent adverse events. (time frame: Up to 71 days). 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 16 Jan 2026.